Trial Outcomes & Findings for COPD Access to Pulmonary Rehabilitation Intervention (NCT NCT03794921)
NCT ID: NCT03794921
Last Updated: 2026-04-02
Results Overview
Daily Step Count was directly measured with a wearable monitoring device. Change in daily step count at 12 weeks compared to baseline from the adjusted mixed model.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
146 participants
Primary outcome timeframe
12 weeks compared to baseline
Results posted on
2026-04-02
Participant Flow
Participants were enrolled from September, 2019-June, 2024 at VA Boston. 146 consented; 109 randomized (57 allocated to intervention, 52 allocated to usual care); 109 included in final analysis and analyzed as intention-to-treat
37 not randomized (28 ineligible, 5 lost to follow-up, 4 withdrew)
Participant milestones
| Measure |
Every Step Counts Intervention
Patients referred to conventional PR or eligible for PR but declined or cannot access were enrolled. After randomization to ESC, participants will be mailed detailed instructions about the website. They will be asked to wear the lightweight, unobtrusive pedometer every day, except while asleep or showering/bathing, during the 12-week intervention period. Subjects will be instructed to upload their date and time-stamped step-count data to the study website at least weekly. Each week, the study computer will run the goal calculation algorithm and provide each participant with his/her daily step-count goal for the week. The week's step-count goal will be displayed on each subject's personal study web page. Participants will be instructed to exercise and reach their individualized step-count goals with walking of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover.
|
Usual Care
Patients referred to conventional PR or eligible for PR but declined or cannot access were enrolled. Using a standardized script at the randomization phone call, study staff will deliver verbal instructions to slowly and steadily increase one's walking and exercise each week. Participants will be asked to perform exercise of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. Use of the Borg rating scale for dyspnea will be reviewed with each participant. Exercise is defined as planned PA, outside of activities performed as part of one's daily routine. Exercise can be walking in the community or using exercise equipment at a local gym. Adapted written materials reinforce the verbal instructions. Participants will receive this 45-page spiral-bound book with information about aerobic and strength training exercises.
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
52
|
|
Overall Study
COMPLETED
|
53
|
43
|
|
Overall Study
NOT COMPLETED
|
4
|
9
|
Reasons for withdrawal
| Measure |
Every Step Counts Intervention
Patients referred to conventional PR or eligible for PR but declined or cannot access were enrolled. After randomization to ESC, participants will be mailed detailed instructions about the website. They will be asked to wear the lightweight, unobtrusive pedometer every day, except while asleep or showering/bathing, during the 12-week intervention period. Subjects will be instructed to upload their date and time-stamped step-count data to the study website at least weekly. Each week, the study computer will run the goal calculation algorithm and provide each participant with his/her daily step-count goal for the week. The week's step-count goal will be displayed on each subject's personal study web page. Participants will be instructed to exercise and reach their individualized step-count goals with walking of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover.
|
Usual Care
Patients referred to conventional PR or eligible for PR but declined or cannot access were enrolled. Using a standardized script at the randomization phone call, study staff will deliver verbal instructions to slowly and steadily increase one's walking and exercise each week. Participants will be asked to perform exercise of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. Use of the Borg rating scale for dyspnea will be reviewed with each participant. Exercise is defined as planned PA, outside of activities performed as part of one's daily routine. Exercise can be walking in the community or using exercise equipment at a local gym. Adapted written materials reinforce the verbal instructions. Participants will receive this 45-page spiral-bound book with information about aerobic and strength training exercises.
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
4
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
Number of participants male/female by group
Baseline characteristics by cohort
| Measure |
Every Step Counts Intervention
n=57 Participants
Patients referred to conventional PR or eligible for PR but declined or cannot access were enrolled. After randomization to ESC, participants will be mailed detailed instructions about the website. They will be asked to wear the lightweight, unobtrusive pedometer every day, except while asleep or showering/bathing, during the 12-week intervention period. Subjects will be instructed to upload their date and time-stamped step-count data to the study website at least weekly. Each week, the study computer will run the goal calculation algorithm and provide each participant with his/her daily step-count goal for the week. The week's step-count goal will be displayed on each subject's personal study web page. Participants will be instructed to exercise and reach their individualized step-count goals with walking of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover.
|
Usual Care
n=52 Participants
Patients referred to conventional PR or eligible for PR but declined or cannot access were enrolled. Using a standardized script at the randomization phone call, study staff will deliver verbal instructions to slowly and steadily increase one's walking and exercise each week. Participants will be asked to perform exercise of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. Use of the Borg rating scale for dyspnea will be reviewed with each participant. Exercise is defined as planned PA, outside of activities performed as part of one's daily routine. Exercise can be walking in the community or using exercise equipment at a local gym. Adapted written materials reinforce the verbal instructions. Participants will receive this 45-page spiral-bound book with information about aerobic and strength training exercises.
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
73.1 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
72.6 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
72.8 years
STANDARD_DEVIATION 7.3 • n=10 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants • Number of participants male/female by group
|
2 Participants
n=5 Participants • Number of participants male/female by group
|
3 Participants
n=10 Participants • Number of participants male/female by group
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants • Number of participants male/female by group
|
50 Participants
n=5 Participants • Number of participants male/female by group
|
106 Participants
n=10 Participants • Number of participants male/female by group
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
46 Participants
n=5 Participants
|
96 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
56 Participants
n=5 Participants
|
52 Participants
n=5 Participants
|
108 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Daily Step Count Average
|
4,222 steps per day
STANDARD_DEVIATION 1,929 • n=5 Participants
|
4,851 steps per day
STANDARD_DEVIATION 2,637 • n=5 Participants
|
4,522 steps per day
STANDARD_DEVIATION 2,305 • n=10 Participants
|
|
FEV1 Percent Predicted
|
73.4 percent predicted of FEV1
STANDARD_DEVIATION 21.9 • n=5 Participants
|
73.2 percent predicted of FEV1
STANDARD_DEVIATION 24.1 • n=5 Participants
|
73.3 percent predicted of FEV1
STANDARD_DEVIATION 22.9 • n=10 Participants
|
PRIMARY outcome
Timeframe: 12 weeks compared to baselineDaily Step Count was directly measured with a wearable monitoring device. Change in daily step count at 12 weeks compared to baseline from the adjusted mixed model.
Outcome measures
| Measure |
Every Step Counts Intervention
n=57 Participants
Patients referred to conventional PR or eligible for PR but declined or cannot access. After randomization to ESC, participants will be mailed detailed instructions about the website. They will be asked to wear the lightweight, unobtrusive pedometer every day, except while asleep or showering/bathing, during the 12-week intervention period. Subjects will be instructed to upload their date and time-stamped step-count data to the study website at least weekly. Each week, the study computer will run the goal calculation algorithm and provide each participant with his/her daily step-count goal for the week. The week's step-count goal will be displayed on each subject's personal study web page. Participants will be instructed to exercise and reach their individualized step-count goals with walking of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover.
|
Usual Care
n=52 Participants
Patients referred to conventional PR or eligible for PR but declined or cannot access. Using a standardized script at the randomization phone call, study staff will deliver verbal instructions to slowly and steadily increase one's walking and exercise each week. Participants will be asked to perform exercise of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. Use of the Borg rating scale for dyspnea will be reviewed with each participant. Exercise is defined as planned PA, outside of activities performed as part of one's daily routine. Exercise can be walking in the community or using exercise equipment at a local gym. Adapted written materials reinforce the verbal instructions. Participants will receive this 45-page spiral-bound book with information about aerobic and strength training exercises.
|
|---|---|---|
|
Physical Activity Measured as Change in Average Daily Step Count
|
1302.34 steps per day
Standard Error 326.33
|
-108.15 steps per day
Standard Error 366.36
|
SECONDARY outcome
Timeframe: 12 weeks compared to baselineAssessed by the Exercise Self-Regulatory Efficacy Scale questionnaire. 16-item questionnaire. Participants indicate their confidence level from 0% (not at all confident) to 100% (highly confident). Change in EX-SRES score at 12 weeks compared to baseline from the adjusted mixed model.
Outcome measures
| Measure |
Every Step Counts Intervention
n=57 Participants
Patients referred to conventional PR or eligible for PR but declined or cannot access. After randomization to ESC, participants will be mailed detailed instructions about the website. They will be asked to wear the lightweight, unobtrusive pedometer every day, except while asleep or showering/bathing, during the 12-week intervention period. Subjects will be instructed to upload their date and time-stamped step-count data to the study website at least weekly. Each week, the study computer will run the goal calculation algorithm and provide each participant with his/her daily step-count goal for the week. The week's step-count goal will be displayed on each subject's personal study web page. Participants will be instructed to exercise and reach their individualized step-count goals with walking of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover.
|
Usual Care
n=52 Participants
Patients referred to conventional PR or eligible for PR but declined or cannot access. Using a standardized script at the randomization phone call, study staff will deliver verbal instructions to slowly and steadily increase one's walking and exercise each week. Participants will be asked to perform exercise of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. Use of the Borg rating scale for dyspnea will be reviewed with each participant. Exercise is defined as planned PA, outside of activities performed as part of one's daily routine. Exercise can be walking in the community or using exercise equipment at a local gym. Adapted written materials reinforce the verbal instructions. Participants will receive this 45-page spiral-bound book with information about aerobic and strength training exercises.
|
|---|---|---|
|
Exercise Self-Regulatory Efficacy Measured as Change Score
|
1.16 score on a scale
Standard Error 3.07
|
-0.86 score on a scale
Standard Error 3.41
|
SECONDARY outcome
Timeframe: 12 weeks compared to baselineAssessed by the St. George's Respiratory Questionnaire. The investigators will use the Total Score which ranges from 0 to 100, with lower scores representing better health related quality of life. Change in total score at 12 weeks compared to baseline from the adjusted mixed model.
Outcome measures
| Measure |
Every Step Counts Intervention
n=57 Participants
Patients referred to conventional PR or eligible for PR but declined or cannot access. After randomization to ESC, participants will be mailed detailed instructions about the website. They will be asked to wear the lightweight, unobtrusive pedometer every day, except while asleep or showering/bathing, during the 12-week intervention period. Subjects will be instructed to upload their date and time-stamped step-count data to the study website at least weekly. Each week, the study computer will run the goal calculation algorithm and provide each participant with his/her daily step-count goal for the week. The week's step-count goal will be displayed on each subject's personal study web page. Participants will be instructed to exercise and reach their individualized step-count goals with walking of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover.
|
Usual Care
n=52 Participants
Patients referred to conventional PR or eligible for PR but declined or cannot access. Using a standardized script at the randomization phone call, study staff will deliver verbal instructions to slowly and steadily increase one's walking and exercise each week. Participants will be asked to perform exercise of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. Use of the Borg rating scale for dyspnea will be reviewed with each participant. Exercise is defined as planned PA, outside of activities performed as part of one's daily routine. Exercise can be walking in the community or using exercise equipment at a local gym. Adapted written materials reinforce the verbal instructions. Participants will receive this 45-page spiral-bound book with information about aerobic and strength training exercises.
|
|---|---|---|
|
Disease Specific Health-Related Quality of Life Measured as Change Score
|
-1.34 score on a scale
Standard Error 1.92
|
-2.30 score on a scale
Standard Error 2.17
|
SECONDARY outcome
Timeframe: 12 weeks compared to baselineThe modified Medical Research Council (mMRC) dyspnea scale ranges from 0 to 4, with higher numbers representing more shortness of breath. Change at 12 weeks compared to baseline from the adjusted mixed model.
Outcome measures
| Measure |
Every Step Counts Intervention
n=57 Participants
Patients referred to conventional PR or eligible for PR but declined or cannot access. After randomization to ESC, participants will be mailed detailed instructions about the website. They will be asked to wear the lightweight, unobtrusive pedometer every day, except while asleep or showering/bathing, during the 12-week intervention period. Subjects will be instructed to upload their date and time-stamped step-count data to the study website at least weekly. Each week, the study computer will run the goal calculation algorithm and provide each participant with his/her daily step-count goal for the week. The week's step-count goal will be displayed on each subject's personal study web page. Participants will be instructed to exercise and reach their individualized step-count goals with walking of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover.
|
Usual Care
n=52 Participants
Patients referred to conventional PR or eligible for PR but declined or cannot access. Using a standardized script at the randomization phone call, study staff will deliver verbal instructions to slowly and steadily increase one's walking and exercise each week. Participants will be asked to perform exercise of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. Use of the Borg rating scale for dyspnea will be reviewed with each participant. Exercise is defined as planned PA, outside of activities performed as part of one's daily routine. Exercise can be walking in the community or using exercise equipment at a local gym. Adapted written materials reinforce the verbal instructions. Participants will receive this 45-page spiral-bound book with information about aerobic and strength training exercises.
|
|---|---|---|
|
Shortness of Breath Rating as Perceived by the Participant Measured as Change Score
|
-0.06 score on a scale
Standard Error 0.20
|
-0.01 score on a scale
Standard Error 0.22
|
SECONDARY outcome
Timeframe: 12 weeks compared to baselineDepression measured by the Beck's Depression Inventory-II questionnaire. 21-items. Scores range with 0 to 63 with higher scores representing greater severity of depression. Change in score at 12 weeks compared to baseline from the adjusted mixed model.
Outcome measures
| Measure |
Every Step Counts Intervention
n=57 Participants
Patients referred to conventional PR or eligible for PR but declined or cannot access. After randomization to ESC, participants will be mailed detailed instructions about the website. They will be asked to wear the lightweight, unobtrusive pedometer every day, except while asleep or showering/bathing, during the 12-week intervention period. Subjects will be instructed to upload their date and time-stamped step-count data to the study website at least weekly. Each week, the study computer will run the goal calculation algorithm and provide each participant with his/her daily step-count goal for the week. The week's step-count goal will be displayed on each subject's personal study web page. Participants will be instructed to exercise and reach their individualized step-count goals with walking of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover.
|
Usual Care
n=52 Participants
Patients referred to conventional PR or eligible for PR but declined or cannot access. Using a standardized script at the randomization phone call, study staff will deliver verbal instructions to slowly and steadily increase one's walking and exercise each week. Participants will be asked to perform exercise of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. Use of the Borg rating scale for dyspnea will be reviewed with each participant. Exercise is defined as planned PA, outside of activities performed as part of one's daily routine. Exercise can be walking in the community or using exercise equipment at a local gym. Adapted written materials reinforce the verbal instructions. Participants will receive this 45-page spiral-bound book with information about aerobic and strength training exercises.
|
|---|---|---|
|
Depression Self-reported on Questionnaire Measured as Change Score
|
-0.83 score on a scale
Standard Error 0.88
|
-1.35 score on a scale
Standard Error 0.99
|
SECONDARY outcome
Timeframe: 12 weeks compared to baselineSelf-reported PA will be assessed with The Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity questionnaire, a 41-item measure of the frequency and duration of PA over a typical week over the past four weeks that is used to calculate estimated caloric expenditure per week. Change in score at 12 weeks compared to baseline from the adjusted mixed model.
Outcome measures
| Measure |
Every Step Counts Intervention
n=57 Participants
Patients referred to conventional PR or eligible for PR but declined or cannot access. After randomization to ESC, participants will be mailed detailed instructions about the website. They will be asked to wear the lightweight, unobtrusive pedometer every day, except while asleep or showering/bathing, during the 12-week intervention period. Subjects will be instructed to upload their date and time-stamped step-count data to the study website at least weekly. Each week, the study computer will run the goal calculation algorithm and provide each participant with his/her daily step-count goal for the week. The week's step-count goal will be displayed on each subject's personal study web page. Participants will be instructed to exercise and reach their individualized step-count goals with walking of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover.
|
Usual Care
n=52 Participants
Patients referred to conventional PR or eligible for PR but declined or cannot access. Using a standardized script at the randomization phone call, study staff will deliver verbal instructions to slowly and steadily increase one's walking and exercise each week. Participants will be asked to perform exercise of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. Use of the Borg rating scale for dyspnea will be reviewed with each participant. Exercise is defined as planned PA, outside of activities performed as part of one's daily routine. Exercise can be walking in the community or using exercise equipment at a local gym. Adapted written materials reinforce the verbal instructions. Participants will receive this 45-page spiral-bound book with information about aerobic and strength training exercises.
|
|---|---|---|
|
CHAMPS Physical Activity Questionnaire Measured as Change Score
All Activities
|
1567.28 caloric expenditure per week
Standard Error 496.62
|
715.33 caloric expenditure per week
Standard Error 550.62
|
|
CHAMPS Physical Activity Questionnaire Measured as Change Score
Moderate Intensity Activities
|
885.45 caloric expenditure per week
Standard Error 371.86
|
279.12 caloric expenditure per week
Standard Error 412.45
|
SECONDARY outcome
Timeframe: 12 weeks compared to baselinePopulation: Difference in number of participants here is due to missing/incomplete data at baseline or 12 week visit
Self-reported physical activity intensity was measured with the 7-item Rapid Assessment of PA (RAPA) questionnaire. Levels placed into three categories based on the highest physical activity level affirmatively endorsed: sedentary (score=1), underactive (score=2-5), and active (score \>6) at 12 weeks compared to baseline.
Outcome measures
| Measure |
Every Step Counts Intervention
n=49 Participants
Patients referred to conventional PR or eligible for PR but declined or cannot access. After randomization to ESC, participants will be mailed detailed instructions about the website. They will be asked to wear the lightweight, unobtrusive pedometer every day, except while asleep or showering/bathing, during the 12-week intervention period. Subjects will be instructed to upload their date and time-stamped step-count data to the study website at least weekly. Each week, the study computer will run the goal calculation algorithm and provide each participant with his/her daily step-count goal for the week. The week's step-count goal will be displayed on each subject's personal study web page. Participants will be instructed to exercise and reach their individualized step-count goals with walking of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover.
|
Usual Care
n=34 Participants
Patients referred to conventional PR or eligible for PR but declined or cannot access. Using a standardized script at the randomization phone call, study staff will deliver verbal instructions to slowly and steadily increase one's walking and exercise each week. Participants will be asked to perform exercise of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. Use of the Borg rating scale for dyspnea will be reviewed with each participant. Exercise is defined as planned PA, outside of activities performed as part of one's daily routine. Exercise can be walking in the community or using exercise equipment at a local gym. Adapted written materials reinforce the verbal instructions. Participants will receive this 45-page spiral-bound book with information about aerobic and strength training exercises.
|
|---|---|---|
|
Rapid Assessment of Physical Activity (RAPA) Questionnaire
Baseline active - 12 week active
|
9 Participants
|
10 Participants
|
|
Rapid Assessment of Physical Activity (RAPA) Questionnaire
Baseline under-active - 12 week active
|
20 Participants
|
6 Participants
|
|
Rapid Assessment of Physical Activity (RAPA) Questionnaire
Baseline active - 12 week under-active
|
4 Participants
|
5 Participants
|
|
Rapid Assessment of Physical Activity (RAPA) Questionnaire
Baseline under-active - 12 week under-active
|
16 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Difference in number of participants analyzed compared to overall analysis is due to drop-outs after baseline and after 12 weeks.
Hospitalization History. Assessment of total number of all cause hospitalizations over the timeframe of 12 weeks based on self-report.
Outcome measures
| Measure |
Every Step Counts Intervention
n=54 Participants
Patients referred to conventional PR or eligible for PR but declined or cannot access. After randomization to ESC, participants will be mailed detailed instructions about the website. They will be asked to wear the lightweight, unobtrusive pedometer every day, except while asleep or showering/bathing, during the 12-week intervention period. Subjects will be instructed to upload their date and time-stamped step-count data to the study website at least weekly. Each week, the study computer will run the goal calculation algorithm and provide each participant with his/her daily step-count goal for the week. The week's step-count goal will be displayed on each subject's personal study web page. Participants will be instructed to exercise and reach their individualized step-count goals with walking of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover.
|
Usual Care
n=45 Participants
Patients referred to conventional PR or eligible for PR but declined or cannot access. Using a standardized script at the randomization phone call, study staff will deliver verbal instructions to slowly and steadily increase one's walking and exercise each week. Participants will be asked to perform exercise of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. Use of the Borg rating scale for dyspnea will be reviewed with each participant. Exercise is defined as planned PA, outside of activities performed as part of one's daily routine. Exercise can be walking in the community or using exercise equipment at a local gym. Adapted written materials reinforce the verbal instructions. Participants will receive this 45-page spiral-bound book with information about aerobic and strength training exercises.
|
|---|---|---|
|
Healthcare Utilization Represented by Number of Hospitalizations Over Timeframe
|
7 count of events
|
3 count of events
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Difference in number of participants analyzed compared to overall analysis is due to drop-outs after baseline and after 12 weeks.
Acute Exacerbation History. Assessment of total number of acute exacerbations (AEs) over the timeframe of 12 weeks based on self-report.
Outcome measures
| Measure |
Every Step Counts Intervention
n=54 Participants
Patients referred to conventional PR or eligible for PR but declined or cannot access. After randomization to ESC, participants will be mailed detailed instructions about the website. They will be asked to wear the lightweight, unobtrusive pedometer every day, except while asleep or showering/bathing, during the 12-week intervention period. Subjects will be instructed to upload their date and time-stamped step-count data to the study website at least weekly. Each week, the study computer will run the goal calculation algorithm and provide each participant with his/her daily step-count goal for the week. The week's step-count goal will be displayed on each subject's personal study web page. Participants will be instructed to exercise and reach their individualized step-count goals with walking of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover.
|
Usual Care
n=45 Participants
Patients referred to conventional PR or eligible for PR but declined or cannot access. Using a standardized script at the randomization phone call, study staff will deliver verbal instructions to slowly and steadily increase one's walking and exercise each week. Participants will be asked to perform exercise of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. Use of the Borg rating scale for dyspnea will be reviewed with each participant. Exercise is defined as planned PA, outside of activities performed as part of one's daily routine. Exercise can be walking in the community or using exercise equipment at a local gym. Adapted written materials reinforce the verbal instructions. Participants will receive this 45-page spiral-bound book with information about aerobic and strength training exercises.
|
|---|---|---|
|
Healthcare Utilization Represented by Number of Acute Exacerbations Over Timeframe
|
1 count of acute exacerbations
|
3 count of acute exacerbations
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeks compared to baselineEuroQoL 5-Dimension Health Questionnaire (EQ-5D) Health Utilities. The responses to the five EQ-5D dimensions (i.e. an EQ-5D health state or profile) can be converted into a single number called an index value. The index value reflects how good or bad the health state is according to the preferences of the general population of the United States. Scale ranges from -0.573 to 1 for the United States, with -0.573 indicating the worst health state and 1 indicating the best health state. Change in score at 12 weeks compared to baseline from the adjusted mixed model.
Outcome measures
| Measure |
Every Step Counts Intervention
n=57 Participants
Patients referred to conventional PR or eligible for PR but declined or cannot access. After randomization to ESC, participants will be mailed detailed instructions about the website. They will be asked to wear the lightweight, unobtrusive pedometer every day, except while asleep or showering/bathing, during the 12-week intervention period. Subjects will be instructed to upload their date and time-stamped step-count data to the study website at least weekly. Each week, the study computer will run the goal calculation algorithm and provide each participant with his/her daily step-count goal for the week. The week's step-count goal will be displayed on each subject's personal study web page. Participants will be instructed to exercise and reach their individualized step-count goals with walking of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover.
|
Usual Care
n=52 Participants
Patients referred to conventional PR or eligible for PR but declined or cannot access. Using a standardized script at the randomization phone call, study staff will deliver verbal instructions to slowly and steadily increase one's walking and exercise each week. Participants will be asked to perform exercise of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. Use of the Borg rating scale for dyspnea will be reviewed with each participant. Exercise is defined as planned PA, outside of activities performed as part of one's daily routine. Exercise can be walking in the community or using exercise equipment at a local gym. Adapted written materials reinforce the verbal instructions. Participants will receive this 45-page spiral-bound book with information about aerobic and strength training exercises.
|
|---|---|---|
|
Health Utilities Measured as Change Score
|
0 score on a scale
Standard Error 0.03
|
0 score on a scale
Standard Error 0.03
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksPopulation: 13 participants were lost to follow-up at 12 weeks
Numbers were assessed by self-report.
Outcome measures
| Measure |
Every Step Counts Intervention
n=53 Participants
Patients referred to conventional PR or eligible for PR but declined or cannot access. After randomization to ESC, participants will be mailed detailed instructions about the website. They will be asked to wear the lightweight, unobtrusive pedometer every day, except while asleep or showering/bathing, during the 12-week intervention period. Subjects will be instructed to upload their date and time-stamped step-count data to the study website at least weekly. Each week, the study computer will run the goal calculation algorithm and provide each participant with his/her daily step-count goal for the week. The week's step-count goal will be displayed on each subject's personal study web page. Participants will be instructed to exercise and reach their individualized step-count goals with walking of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover.
|
Usual Care
n=43 Participants
Patients referred to conventional PR or eligible for PR but declined or cannot access. Using a standardized script at the randomization phone call, study staff will deliver verbal instructions to slowly and steadily increase one's walking and exercise each week. Participants will be asked to perform exercise of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. Use of the Borg rating scale for dyspnea will be reviewed with each participant. Exercise is defined as planned PA, outside of activities performed as part of one's daily routine. Exercise can be walking in the community or using exercise equipment at a local gym. Adapted written materials reinforce the verbal instructions. Participants will receive this 45-page spiral-bound book with information about aerobic and strength training exercises.
|
|---|---|---|
|
Number of Participants Who Plan to Enroll in Conventional Pulmonary Rehabilitation After Participating in the Research Study
|
32 Participants
|
25 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeks compared to baselineBristol COPD Knowledge Questionnaire was used. 13-items that usually takes between 10 and 20 minutes to complete. Percent of questions scored correctly is assessed and range from 0 to 100 %. Change in score at 12 weeks compared to baseline from the adjusted mixed model.
Outcome measures
| Measure |
Every Step Counts Intervention
n=57 Participants
Patients referred to conventional PR or eligible for PR but declined or cannot access. After randomization to ESC, participants will be mailed detailed instructions about the website. They will be asked to wear the lightweight, unobtrusive pedometer every day, except while asleep or showering/bathing, during the 12-week intervention period. Subjects will be instructed to upload their date and time-stamped step-count data to the study website at least weekly. Each week, the study computer will run the goal calculation algorithm and provide each participant with his/her daily step-count goal for the week. The week's step-count goal will be displayed on each subject's personal study web page. Participants will be instructed to exercise and reach their individualized step-count goals with walking of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover.
|
Usual Care
n=52 Participants
Patients referred to conventional PR or eligible for PR but declined or cannot access. Using a standardized script at the randomization phone call, study staff will deliver verbal instructions to slowly and steadily increase one's walking and exercise each week. Participants will be asked to perform exercise of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. Use of the Borg rating scale for dyspnea will be reviewed with each participant. Exercise is defined as planned PA, outside of activities performed as part of one's daily routine. Exercise can be walking in the community or using exercise equipment at a local gym. Adapted written materials reinforce the verbal instructions. Participants will receive this 45-page spiral-bound book with information about aerobic and strength training exercises.
|
|---|---|---|
|
COPD Knowledge Measured as Change Score
|
1.03 score on a scale
Standard Error 1.90
|
0.47 score on a scale
Standard Error 2.12
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeks compared to baselinePopulation: Score
Epworth Sleepiness Scale was used. 8 questions, each on a scale of 0-3. Minimum score is 0 and maximum score is 24. 0-5 Lower Normal Daytime Sleepiness 6-10 Higher Normal Daytime Sleepiness 11-12 Mild Excessive Daytime Sleepiness 13-15 Moderate Excessive Daytime Sleepiness 16-24 Severe Excessive Daytime Sleepiness. Change in score at 12 weeks compared to baseline from the adjusted mixed model.
Outcome measures
| Measure |
Every Step Counts Intervention
n=57 Participants
Patients referred to conventional PR or eligible for PR but declined or cannot access. After randomization to ESC, participants will be mailed detailed instructions about the website. They will be asked to wear the lightweight, unobtrusive pedometer every day, except while asleep or showering/bathing, during the 12-week intervention period. Subjects will be instructed to upload their date and time-stamped step-count data to the study website at least weekly. Each week, the study computer will run the goal calculation algorithm and provide each participant with his/her daily step-count goal for the week. The week's step-count goal will be displayed on each subject's personal study web page. Participants will be instructed to exercise and reach their individualized step-count goals with walking of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover.
|
Usual Care
n=52 Participants
Patients referred to conventional PR or eligible for PR but declined or cannot access. Using a standardized script at the randomization phone call, study staff will deliver verbal instructions to slowly and steadily increase one's walking and exercise each week. Participants will be asked to perform exercise of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. Use of the Borg rating scale for dyspnea will be reviewed with each participant. Exercise is defined as planned PA, outside of activities performed as part of one's daily routine. Exercise can be walking in the community or using exercise equipment at a local gym. Adapted written materials reinforce the verbal instructions. Participants will receive this 45-page spiral-bound book with information about aerobic and strength training exercises.
|
|---|---|---|
|
Sleepiness Measured as Change Score
|
-0.51 score on a scale
Standard Error 0.61
|
-0.44 score on a scale
Standard Error 0.68
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeks compared to baselineMOS Social Support Survey was used. 18 items with scores ranging from 0 to 100, with higher scores representing greater social support. Change in score at 12 weeks compared to baseline from the adjusted mixed model.
Outcome measures
| Measure |
Every Step Counts Intervention
n=57 Participants
Patients referred to conventional PR or eligible for PR but declined or cannot access. After randomization to ESC, participants will be mailed detailed instructions about the website. They will be asked to wear the lightweight, unobtrusive pedometer every day, except while asleep or showering/bathing, during the 12-week intervention period. Subjects will be instructed to upload their date and time-stamped step-count data to the study website at least weekly. Each week, the study computer will run the goal calculation algorithm and provide each participant with his/her daily step-count goal for the week. The week's step-count goal will be displayed on each subject's personal study web page. Participants will be instructed to exercise and reach their individualized step-count goals with walking of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover.
|
Usual Care
n=52 Participants
Patients referred to conventional PR or eligible for PR but declined or cannot access. Using a standardized script at the randomization phone call, study staff will deliver verbal instructions to slowly and steadily increase one's walking and exercise each week. Participants will be asked to perform exercise of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. Use of the Borg rating scale for dyspnea will be reviewed with each participant. Exercise is defined as planned PA, outside of activities performed as part of one's daily routine. Exercise can be walking in the community or using exercise equipment at a local gym. Adapted written materials reinforce the verbal instructions. Participants will receive this 45-page spiral-bound book with information about aerobic and strength training exercises.
|
|---|---|---|
|
Social Support Measured as Change Score
|
-0.08 score on a scale
Standard Error 0.12
|
0.02 score on a scale
Standard Error 0.13
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeks compared to baselineThe Veterans RAND-36 is a 36-item self-report measure of general HRQL in U.S. Veterans based on the original RAND SF-36. Items assess participants' perception of their physical and mental health. Physical health (PCS) and mental health (MCS) component scores will be calculated as t scores normed to the general U.S. Veteran population with a mean score of 50 and a standard deviation of 10, with higher scores indicating better health outcomes. Change score at 12 weeks compared to baseline from the adjusted mixed model.
Outcome measures
| Measure |
Every Step Counts Intervention
n=57 Participants
Patients referred to conventional PR or eligible for PR but declined or cannot access. After randomization to ESC, participants will be mailed detailed instructions about the website. They will be asked to wear the lightweight, unobtrusive pedometer every day, except while asleep or showering/bathing, during the 12-week intervention period. Subjects will be instructed to upload their date and time-stamped step-count data to the study website at least weekly. Each week, the study computer will run the goal calculation algorithm and provide each participant with his/her daily step-count goal for the week. The week's step-count goal will be displayed on each subject's personal study web page. Participants will be instructed to exercise and reach their individualized step-count goals with walking of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover.
|
Usual Care
n=52 Participants
Patients referred to conventional PR or eligible for PR but declined or cannot access. Using a standardized script at the randomization phone call, study staff will deliver verbal instructions to slowly and steadily increase one's walking and exercise each week. Participants will be asked to perform exercise of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. Use of the Borg rating scale for dyspnea will be reviewed with each participant. Exercise is defined as planned PA, outside of activities performed as part of one's daily routine. Exercise can be walking in the community or using exercise equipment at a local gym. Adapted written materials reinforce the verbal instructions. Participants will receive this 45-page spiral-bound book with information about aerobic and strength training exercises.
|
|---|---|---|
|
General Health-Related Quality of Life Measured as Change Score
Physical Component Scale
|
1.14 t-score
Standard Error 1.13
|
0.28 t-score
Standard Error 1.25
|
|
General Health-Related Quality of Life Measured as Change Score
Mental Component Scale
|
1.47 t-score
Standard Error 1.43
|
0.51 t-score
Standard Error 1.59
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeks compared to baselinePopulation: Only participants who participated in the study in-person performed the 6MWT.
In-clinic test that measures exercise capacity. Change in 6MWT distance at 12 weeks compared to baseline from the adjusted mixed model.
Outcome measures
| Measure |
Every Step Counts Intervention
n=27 Participants
Patients referred to conventional PR or eligible for PR but declined or cannot access. After randomization to ESC, participants will be mailed detailed instructions about the website. They will be asked to wear the lightweight, unobtrusive pedometer every day, except while asleep or showering/bathing, during the 12-week intervention period. Subjects will be instructed to upload their date and time-stamped step-count data to the study website at least weekly. Each week, the study computer will run the goal calculation algorithm and provide each participant with his/her daily step-count goal for the week. The week's step-count goal will be displayed on each subject's personal study web page. Participants will be instructed to exercise and reach their individualized step-count goals with walking of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover.
|
Usual Care
n=25 Participants
Patients referred to conventional PR or eligible for PR but declined or cannot access. Using a standardized script at the randomization phone call, study staff will deliver verbal instructions to slowly and steadily increase one's walking and exercise each week. Participants will be asked to perform exercise of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. Use of the Borg rating scale for dyspnea will be reviewed with each participant. Exercise is defined as planned PA, outside of activities performed as part of one's daily routine. Exercise can be walking in the community or using exercise equipment at a local gym. Adapted written materials reinforce the verbal instructions. Participants will receive this 45-page spiral-bound book with information about aerobic and strength training exercises.
|
|---|---|---|
|
Change in 6-Minute Walk Test Distance
|
22.69 meters
Standard Error 13.20
|
24.63 meters
Standard Error 14.00
|
Adverse Events
Every Step Counts Intervention
Serious events: 7 serious events
Other events: 38 other events
Deaths: 0 deaths
Usual Care
Serious events: 3 serious events
Other events: 21 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Every Step Counts Intervention
n=57 participants at risk
Patients referred to conventional PR or eligible for PR but declined or cannot access were enrolled. After randomization to ESC, participants will be mailed detailed instructions about the website. They will be asked to wear the lightweight, unobtrusive pedometer every day, except while asleep or showering/bathing, during the 12-week intervention period. Subjects will be instructed to upload their date and time-stamped step-count data to the study website at least weekly. Each week, the study computer will run the goal calculation algorithm and provide each participant with his/her daily step-count goal for the week. The week's step-count goal will be displayed on each subject's personal study web page. Participants will be instructed to exercise and reach their individualized step-count goals with walking of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover.
|
Usual Care
n=52 participants at risk
Patients referred to conventional PR or eligible for PR but declined or cannot access were enrolled. Using a standardized script at the randomization phone call, study staff will deliver verbal instructions to slowly and steadily increase one's walking and exercise each week. Participants will be asked to perform exercise of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. Use of the Borg rating scale for dyspnea will be reviewed with each participant. Exercise is defined as planned PA, outside of activities performed as part of one's daily routine. Exercise can be walking in the community or using exercise equipment at a local gym. Adapted written materials reinforce the verbal instructions. Participants will receive this 45-page spiral-bound book with information about aerobic and strength training exercises.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
3.5%
2/57 • Number of events 2 • Each participant was followed from enrollment until the end of the intervention, up to 12 weeks, for adverse events.
Adverse events were monitored and assessed at follow-up study visits. We didn't specifically ask by organ system, but classified by organ systems after we received participant reports.
|
1.9%
1/52 • Number of events 1 • Each participant was followed from enrollment until the end of the intervention, up to 12 weeks, for adverse events.
Adverse events were monitored and assessed at follow-up study visits. We didn't specifically ask by organ system, but classified by organ systems after we received participant reports.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
3.5%
2/57 • Number of events 2 • Each participant was followed from enrollment until the end of the intervention, up to 12 weeks, for adverse events.
Adverse events were monitored and assessed at follow-up study visits. We didn't specifically ask by organ system, but classified by organ systems after we received participant reports.
|
1.9%
1/52 • Number of events 1 • Each participant was followed from enrollment until the end of the intervention, up to 12 weeks, for adverse events.
Adverse events were monitored and assessed at follow-up study visits. We didn't specifically ask by organ system, but classified by organ systems after we received participant reports.
|
|
Cardiac disorders
Cardiac
|
3.5%
2/57 • Number of events 2 • Each participant was followed from enrollment until the end of the intervention, up to 12 weeks, for adverse events.
Adverse events were monitored and assessed at follow-up study visits. We didn't specifically ask by organ system, but classified by organ systems after we received participant reports.
|
0.00%
0/52 • Each participant was followed from enrollment until the end of the intervention, up to 12 weeks, for adverse events.
Adverse events were monitored and assessed at follow-up study visits. We didn't specifically ask by organ system, but classified by organ systems after we received participant reports.
|
|
Renal and urinary disorders
Renal
|
1.8%
1/57 • Number of events 1 • Each participant was followed from enrollment until the end of the intervention, up to 12 weeks, for adverse events.
Adverse events were monitored and assessed at follow-up study visits. We didn't specifically ask by organ system, but classified by organ systems after we received participant reports.
|
1.9%
1/52 • Number of events 1 • Each participant was followed from enrollment until the end of the intervention, up to 12 weeks, for adverse events.
Adverse events were monitored and assessed at follow-up study visits. We didn't specifically ask by organ system, but classified by organ systems after we received participant reports.
|
|
Blood and lymphatic system disorders
Blood
|
1.8%
1/57 • Number of events 1 • Each participant was followed from enrollment until the end of the intervention, up to 12 weeks, for adverse events.
Adverse events were monitored and assessed at follow-up study visits. We didn't specifically ask by organ system, but classified by organ systems after we received participant reports.
|
0.00%
0/52 • Each participant was followed from enrollment until the end of the intervention, up to 12 weeks, for adverse events.
Adverse events were monitored and assessed at follow-up study visits. We didn't specifically ask by organ system, but classified by organ systems after we received participant reports.
|
Other adverse events
| Measure |
Every Step Counts Intervention
n=57 participants at risk
Patients referred to conventional PR or eligible for PR but declined or cannot access were enrolled. After randomization to ESC, participants will be mailed detailed instructions about the website. They will be asked to wear the lightweight, unobtrusive pedometer every day, except while asleep or showering/bathing, during the 12-week intervention period. Subjects will be instructed to upload their date and time-stamped step-count data to the study website at least weekly. Each week, the study computer will run the goal calculation algorithm and provide each participant with his/her daily step-count goal for the week. The week's step-count goal will be displayed on each subject's personal study web page. Participants will be instructed to exercise and reach their individualized step-count goals with walking of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover.
|
Usual Care
n=52 participants at risk
Patients referred to conventional PR or eligible for PR but declined or cannot access were enrolled. Using a standardized script at the randomization phone call, study staff will deliver verbal instructions to slowly and steadily increase one's walking and exercise each week. Participants will be asked to perform exercise of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. Use of the Borg rating scale for dyspnea will be reviewed with each participant. Exercise is defined as planned PA, outside of activities performed as part of one's daily routine. Exercise can be walking in the community or using exercise equipment at a local gym. Adapted written materials reinforce the verbal instructions. Participants will receive this 45-page spiral-bound book with information about aerobic and strength training exercises.
|
|---|---|---|
|
Cardiac disorders
Chest
|
8.8%
5/57 • Number of events 6 • Each participant was followed from enrollment until the end of the intervention, up to 12 weeks, for adverse events.
Adverse events were monitored and assessed at follow-up study visits. We didn't specifically ask by organ system, but classified by organ systems after we received participant reports.
|
7.7%
4/52 • Number of events 5 • Each participant was followed from enrollment until the end of the intervention, up to 12 weeks, for adverse events.
Adverse events were monitored and assessed at follow-up study visits. We didn't specifically ask by organ system, but classified by organ systems after we received participant reports.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
19.3%
11/57 • Number of events 15 • Each participant was followed from enrollment until the end of the intervention, up to 12 weeks, for adverse events.
Adverse events were monitored and assessed at follow-up study visits. We didn't specifically ask by organ system, but classified by organ systems after we received participant reports.
|
23.1%
12/52 • Number of events 16 • Each participant was followed from enrollment until the end of the intervention, up to 12 weeks, for adverse events.
Adverse events were monitored and assessed at follow-up study visits. We didn't specifically ask by organ system, but classified by organ systems after we received participant reports.
|
|
Ear and labyrinth disorders
Ear
|
1.8%
1/57 • Number of events 1 • Each participant was followed from enrollment until the end of the intervention, up to 12 weeks, for adverse events.
Adverse events were monitored and assessed at follow-up study visits. We didn't specifically ask by organ system, but classified by organ systems after we received participant reports.
|
0.00%
0/52 • Each participant was followed from enrollment until the end of the intervention, up to 12 weeks, for adverse events.
Adverse events were monitored and assessed at follow-up study visits. We didn't specifically ask by organ system, but classified by organ systems after we received participant reports.
|
|
Gastrointestinal disorders
Gastrointestinal
|
1.8%
1/57 • Number of events 1 • Each participant was followed from enrollment until the end of the intervention, up to 12 weeks, for adverse events.
Adverse events were monitored and assessed at follow-up study visits. We didn't specifically ask by organ system, but classified by organ systems after we received participant reports.
|
0.00%
0/52 • Each participant was followed from enrollment until the end of the intervention, up to 12 weeks, for adverse events.
Adverse events were monitored and assessed at follow-up study visits. We didn't specifically ask by organ system, but classified by organ systems after we received participant reports.
|
|
General disorders
General
|
1.8%
1/57 • Number of events 1 • Each participant was followed from enrollment until the end of the intervention, up to 12 weeks, for adverse events.
Adverse events were monitored and assessed at follow-up study visits. We didn't specifically ask by organ system, but classified by organ systems after we received participant reports.
|
0.00%
0/52 • Each participant was followed from enrollment until the end of the intervention, up to 12 weeks, for adverse events.
Adverse events were monitored and assessed at follow-up study visits. We didn't specifically ask by organ system, but classified by organ systems after we received participant reports.
|
|
Infections and infestations
Infections
|
3.5%
2/57 • Number of events 2 • Each participant was followed from enrollment until the end of the intervention, up to 12 weeks, for adverse events.
Adverse events were monitored and assessed at follow-up study visits. We didn't specifically ask by organ system, but classified by organ systems after we received participant reports.
|
0.00%
0/52 • Each participant was followed from enrollment until the end of the intervention, up to 12 weeks, for adverse events.
Adverse events were monitored and assessed at follow-up study visits. We didn't specifically ask by organ system, but classified by organ systems after we received participant reports.
|
|
Injury, poisoning and procedural complications
Injury
|
1.8%
1/57 • Number of events 1 • Each participant was followed from enrollment until the end of the intervention, up to 12 weeks, for adverse events.
Adverse events were monitored and assessed at follow-up study visits. We didn't specifically ask by organ system, but classified by organ systems after we received participant reports.
|
0.00%
0/52 • Each participant was followed from enrollment until the end of the intervention, up to 12 weeks, for adverse events.
Adverse events were monitored and assessed at follow-up study visits. We didn't specifically ask by organ system, but classified by organ systems after we received participant reports.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/57 • Each participant was followed from enrollment until the end of the intervention, up to 12 weeks, for adverse events.
Adverse events were monitored and assessed at follow-up study visits. We didn't specifically ask by organ system, but classified by organ systems after we received participant reports.
|
1.9%
1/52 • Number of events 1 • Each participant was followed from enrollment until the end of the intervention, up to 12 weeks, for adverse events.
Adverse events were monitored and assessed at follow-up study visits. We didn't specifically ask by organ system, but classified by organ systems after we received participant reports.
|
|
Nervous system disorders
Nervous system
|
1.8%
1/57 • Number of events 1 • Each participant was followed from enrollment until the end of the intervention, up to 12 weeks, for adverse events.
Adverse events were monitored and assessed at follow-up study visits. We didn't specifically ask by organ system, but classified by organ systems after we received participant reports.
|
0.00%
0/52 • Each participant was followed from enrollment until the end of the intervention, up to 12 weeks, for adverse events.
Adverse events were monitored and assessed at follow-up study visits. We didn't specifically ask by organ system, but classified by organ systems after we received participant reports.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
61.4%
35/57 • Number of events 55 • Each participant was followed from enrollment until the end of the intervention, up to 12 weeks, for adverse events.
Adverse events were monitored and assessed at follow-up study visits. We didn't specifically ask by organ system, but classified by organ systems after we received participant reports.
|
25.0%
13/52 • Number of events 23 • Each participant was followed from enrollment until the end of the intervention, up to 12 weeks, for adverse events.
Adverse events were monitored and assessed at follow-up study visits. We didn't specifically ask by organ system, but classified by organ systems after we received participant reports.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place