Trial Outcomes & Findings for Physical Activity for Older Adults Chronic Low Back Pain (NCT NCT02327325)
NCT ID: NCT02327325
Last Updated: 2018-09-06
Results Overview
This test requires the participants to stand from a standard arm chair, walk 3 meters and then return to sitting in the same chair. Greater number of seconds is associated with poorer physical function. Therefore, a positive change from baseline to follow-up means worsening function; a negative change (e.g., lower score at follow-up than at baseline) indicated improving function.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Change from baseline to 12-week follow-up
Results posted on
2018-09-06
Participant Flow
Participant milestones
| Measure |
Physical Activity Only
12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.
Physical Activity: 12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.
|
Physical Activity + Cognitive Behavioral Therapy
12-week combined home-based physical activity and cognitive behavioral program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive physical activity program including stretching, strengthening and aerobic activity. Cognitive behavioral component includes training in multiple skills for managing pain.
Physical Activity: 12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.
Cognitive Behavioral Therapy: Telephone-based training in multiple skills for managing low back pain.
|
Wait List Control Group
Will receive the physical activity only or physical activity + cognitive behavioral therapy (based on participant choice) after completing all follow-up assessments.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
5
|
Reasons for withdrawal
| Measure |
Physical Activity Only
12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.
Physical Activity: 12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.
|
Physical Activity + Cognitive Behavioral Therapy
12-week combined home-based physical activity and cognitive behavioral program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive physical activity program including stretching, strengthening and aerobic activity. Cognitive behavioral component includes training in multiple skills for managing pain.
Physical Activity: 12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.
Cognitive Behavioral Therapy: Telephone-based training in multiple skills for managing low back pain.
|
Wait List Control Group
Will receive the physical activity only or physical activity + cognitive behavioral therapy (based on participant choice) after completing all follow-up assessments.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
4
|
|
Overall Study
Excluded by Study Team
|
0
|
0
|
1
|
Baseline Characteristics
Two participants declined to answer.
Baseline characteristics by cohort
| Measure |
Physical Activity Only
n=20 Participants
12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.
Physical Activity: 12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.
|
Physical Activity + Cognitive Behavioral Therapy
n=20 Participants
12-week combined home-based physical activity and cognitive behavioral program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive physical activity program including stretching, strengthening and aerobic activity. Cognitive behavioral component includes training in multiple skills for managing pain.
Physical Activity: 12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.
Cognitive Behavioral Therapy: Telephone-based training in multiple skills for managing low back pain.
|
Wait List Control Group
n=20 Participants
Will receive the physical activity only or physical activity + cognitive behavioral therapy (based on participant choice) after completing all follow-up assessments.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
69.6 years
STANDARD_DEVIATION 3.5 • n=20 Participants
|
69.5 years
STANDARD_DEVIATION 4.0 • n=20 Participants
|
71.9 years
STANDARD_DEVIATION 6.5 • n=20 Participants
|
70.3 years
STANDARD_DEVIATION 4.9 • n=60 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
4 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=20 Participants
|
18 Participants
n=20 Participants
|
19 Participants
n=20 Participants
|
56 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
59 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
31 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
28 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=60 Participants
|
|
Education Level
At least some college
|
13 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
31 Participants
n=60 Participants
|
|
Education Level
High school or technical school
|
7 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
29 Participants
n=60 Participants
|
|
Employment Status
Disabled
|
7 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
21 Participants
n=60 Participants
|
|
Employment Status
Other
|
13 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
39 Participants
n=60 Participants
|
|
Marital Status
Married
|
9 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
16 Participants
n=20 Participants
|
38 Participants
n=60 Participants
|
|
Marital Status
Other
|
11 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
22 Participants
n=60 Participants
|
|
Household Financial Status
Low income
|
4 Participants
n=20 Participants • Two participants declined to answer.
|
6 Participants
n=19 Participants • Two participants declined to answer.
|
6 Participants
n=19 Participants • Two participants declined to answer.
|
16 Participants
n=58 Participants • Two participants declined to answer.
|
|
Household Financial Status
Other
|
16 Participants
n=20 Participants • Two participants declined to answer.
|
13 Participants
n=19 Participants • Two participants declined to answer.
|
13 Participants
n=19 Participants • Two participants declined to answer.
|
42 Participants
n=58 Participants • Two participants declined to answer.
|
PRIMARY outcome
Timeframe: Change from baseline to 12-week follow-upPopulation: The analysis populations includes all participants except for one who was unable to stand without assistance and declined to perform this test at both baseline and follow-up.
This test requires the participants to stand from a standard arm chair, walk 3 meters and then return to sitting in the same chair. Greater number of seconds is associated with poorer physical function. Therefore, a positive change from baseline to follow-up means worsening function; a negative change (e.g., lower score at follow-up than at baseline) indicated improving function.
Outcome measures
| Measure |
Physical Activity Only
n=20 Participants
12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.
Physical Activity: 12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.
|
Physical Activity + Cognitive Behavioral Therapy
n=19 Participants
12-week combined home-based physical activity and cognitive behavioral program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive physical activity program including stretching, strengthening and aerobic activity. Cognitive behavioral component includes training in multiple skills for managing pain.
Physical Activity: 12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.
Cognitive Behavioral Therapy: Telephone-based training in multiple skills for managing low back pain.
|
Wait List Control Group
n=20 Participants
Will receive the physical activity only or physical activity + cognitive behavioral therapy (based on participant choice) after completing all follow-up assessments.
|
|---|---|---|---|
|
Timed Get-Up-And Go
|
-1.84 seconds
Interval -4.01 to 0.33
|
-2.15 seconds
Interval -4.52 to 0.21
|
1.11 seconds
Interval -1.24 to 3.47
|
PRIMARY outcome
Timeframe: Change from baseline to 12-week follow-upPopulation: 18 participants are missing data from this questionnaire because they entered a response of "don't know" for one or more items, and there were not adequate instructions for scoring the questionnaire with the missing data.
Self-reported physical function/disability measure that captures both activities of daily living and instrumental activities of daily living. It consists of 20-items scored on a 0-3 scale with a summed 0-100-unit scale. Higher scores are associated with worse function. Therefore a positive change score indicates worsening over time; negative change score (e.g., lower score at follow-up) indicates improvement.
Outcome measures
| Measure |
Physical Activity Only
n=16 Participants
12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.
Physical Activity: 12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.
|
Physical Activity + Cognitive Behavioral Therapy
n=11 Participants
12-week combined home-based physical activity and cognitive behavioral program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive physical activity program including stretching, strengthening and aerobic activity. Cognitive behavioral component includes training in multiple skills for managing pain.
Physical Activity: 12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.
Cognitive Behavioral Therapy: Telephone-based training in multiple skills for managing low back pain.
|
Wait List Control Group
n=15 Participants
Will receive the physical activity only or physical activity + cognitive behavioral therapy (based on participant choice) after completing all follow-up assessments.
|
|---|---|---|---|
|
PROMIS Health Assessment Questionnaire
|
-2.90 units on a scale
Interval -7.22 to 1.43
|
-0.89 units on a scale
Interval -6.36 to 4.57
|
3.21 units on a scale
Interval -1.61 to 8.02
|
SECONDARY outcome
Timeframe: Change from baseline to 12-week follow-upThis measure captures items that are specific functional tasks that may be missed on standardized questionnaires. The measure consists of 3 items specifically provided by the patient. Each item provided by the patient is score from a 0 (Unable to perform task) to 10 (able to complete the activity without difficulty) scale. Higher change scores from baseline to follow up indicate more improvement (total range 0-30).
Outcome measures
| Measure |
Physical Activity Only
n=20 Participants
12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.
Physical Activity: 12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.
|
Physical Activity + Cognitive Behavioral Therapy
n=20 Participants
12-week combined home-based physical activity and cognitive behavioral program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive physical activity program including stretching, strengthening and aerobic activity. Cognitive behavioral component includes training in multiple skills for managing pain.
Physical Activity: 12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.
Cognitive Behavioral Therapy: Telephone-based training in multiple skills for managing low back pain.
|
Wait List Control Group
n=20 Participants
Will receive the physical activity only or physical activity + cognitive behavioral therapy (based on participant choice) after completing all follow-up assessments.
|
|---|---|---|---|
|
Patient Specific Functional Scale
|
3.72 units on a scale
Interval 0.89 to 6.55
|
3.00 units on a scale
Interval -0.04 to 6.04
|
0.08 units on a scale
Interval -3.12 to 3.39
|
SECONDARY outcome
Timeframe: Change from baseline to 12-week follow-up24-item self-report measure of low back pain-specific disability. Higher scores indicate worse function, with a range of 0=no disability to 24=maximum disability measured by the scale. Therefore a positive change score indicates worsening. A negative change score (e.g., lower score at follow-up) indicates improvement.
Outcome measures
| Measure |
Physical Activity Only
n=20 Participants
12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.
Physical Activity: 12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.
|
Physical Activity + Cognitive Behavioral Therapy
n=20 Participants
12-week combined home-based physical activity and cognitive behavioral program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive physical activity program including stretching, strengthening and aerobic activity. Cognitive behavioral component includes training in multiple skills for managing pain.
Physical Activity: 12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.
Cognitive Behavioral Therapy: Telephone-based training in multiple skills for managing low back pain.
|
Wait List Control Group
n=20 Participants
Will receive the physical activity only or physical activity + cognitive behavioral therapy (based on participant choice) after completing all follow-up assessments.
|
|---|---|---|---|
|
Roland-Morris Disease Specific Disability Questionnaire
|
-3.21 units on a scale
Interval -5.01 to -1.41
|
-1.11 units on a scale
Interval -3.05 to 0.83
|
0.89 units on a scale
Interval -1.11 to 2.88
|
SECONDARY outcome
Timeframe: Change from baseline to 12-week follow-upPopulation: 6 participants are missing data from this questionnaire because they entered a response of "don't know" for one or more items, and there were not adequate instructions for scoring the questionnaire with the missing data.
This is a validated 5-item questionnaire that assesses patients' satisfaction with their ability to complete basic functional tasks that are often affected by lower extremity OA, including stair-climbing, walking, doing housework (light and heavy, and lifting and carrying. All items are rated on a 7-point scale ranging from Very Dissatisfied (-3) Very Satisfied (+3). A positive change score indicates improvement, and a negative change score indicates worsening.
Outcome measures
| Measure |
Physical Activity Only
n=18 Participants
12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.
Physical Activity: 12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.
|
Physical Activity + Cognitive Behavioral Therapy
n=18 Participants
12-week combined home-based physical activity and cognitive behavioral program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive physical activity program including stretching, strengthening and aerobic activity. Cognitive behavioral component includes training in multiple skills for managing pain.
Physical Activity: 12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.
Cognitive Behavioral Therapy: Telephone-based training in multiple skills for managing low back pain.
|
Wait List Control Group
n=18 Participants
Will receive the physical activity only or physical activity + cognitive behavioral therapy (based on participant choice) after completing all follow-up assessments.
|
|---|---|---|---|
|
Satisfaction With Physical Function Scale
|
3.11 units on a scale
Interval -0.23 to 6.46
|
3.06 units on a scale
Interval -0.68 to 6.81
|
2.96 units on a scale
Interval -0.58 to 6.49
|
Adverse Events
Physical Activity Only
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Physical Activity + Cognitive Behavioral Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wait List Control Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Physical Activity Only
n=20 participants at risk
12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.
Physical Activity: 12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.
|
Physical Activity + Cognitive Behavioral Therapy
n=20 participants at risk
12-week combined home-based physical activity and cognitive behavioral program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive physical activity program including stretching, strengthening and aerobic activity. Cognitive behavioral component includes training in multiple skills for managing pain.
Physical Activity: 12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.
Cognitive Behavioral Therapy: Telephone-based training in multiple skills for managing low back pain.
|
Wait List Control Group
n=20 participants at risk
Will receive the physical activity only or physical activity + cognitive behavioral therapy (based on participant choice) after completing all follow-up assessments.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Hospitalization
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
0.00%
0/20
|
|
Renal and urinary disorders
Hospitalizatoin
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Kelli Allen, PhD
Health Services Research & Development, Durham VA Healthcare System
Phone: 919-286-0411
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place