Trial Outcomes & Findings for Physical Activity and Neuropsychological Outcomes in a Cancer Population (NCT NCT02332876)
NCT ID: NCT02332876
Last Updated: 2018-07-11
Results Overview
Change in score on the NIH Toolbox Oral Symbol Digit test, an objective measure of processing speed, from baseline to 12 weeks. The Oral Symbol Digit test provides a raw score (possible range is 0-144). A higher score indicates better processing speed.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
87 participants
Primary outcome timeframe
Baseline to 12 weeks
Results posted on
2018-07-11
Participant Flow
Participant milestones
| Measure |
Exercise Intervention
This arm received a Fitbit along with a 12-week individually tailored phone and email-based exercise program.
Exercise
|
Wellness Waitlist Control
This arm will receive emails on the same schedule as the exercise arm, that cover a variety of health and wellness topics. At the end of the 12 weeks, participants will be able to start the exercise program.
Control
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
44
|
|
Overall Study
COMPLETED
|
42
|
43
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Exercise Intervention
This arm received a Fitbit along with a 12-week individually tailored phone and email-based exercise program.
Exercise
|
Wellness Waitlist Control
This arm will receive emails on the same schedule as the exercise arm, that cover a variety of health and wellness topics. At the end of the 12 weeks, participants will be able to start the exercise program.
Control
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Physical Activity and Neuropsychological Outcomes in a Cancer Population
Baseline characteristics by cohort
| Measure |
Exercise Intervention
n=43 Participants
This arm received a Fitbit along with a 12-week individually tailored phone and email-based exercise program.
Exercise
|
Wellness Waitlist Control
n=44 Participants
This arm will receive emails on the same schedule as the exercise arm, that cover a variety of health and wellness topics. At the end of the 12 weeks, participants will be able to start the exercise program.
Control
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.2 years
STANDARD_DEVIATION 11.37 • n=39 Participants
|
56.2 years
STANDARD_DEVIATION 9.30 • n=41 Participants
|
57.2 years
STANDARD_DEVIATION 10.36 • n=35 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=39 Participants
|
44 Participants
n=41 Participants
|
87 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=39 Participants
|
37 Participants
n=41 Participants
|
72 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=39 Participants
|
35 Participants
n=41 Participants
|
71 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 weeksChange in score on the NIH Toolbox Oral Symbol Digit test, an objective measure of processing speed, from baseline to 12 weeks. The Oral Symbol Digit test provides a raw score (possible range is 0-144). A higher score indicates better processing speed.
Outcome measures
| Measure |
Exercise Intervention
n=43 Participants
This arm received a Fitbit along with a 12-week individually tailored phone and email-based exercise program.
Exercise
|
Wellness Waitlist Control
n=44 Participants
This arm will receive emails on the same schedule as the exercise arm, that cover a variety of health and wellness topics. At the end of the 12 weeks, participants will be able to start the exercise program.
Control
|
|---|---|---|
|
National Institutes of Health Toolbox - Cognition Domain- Oral Symbol Digit Test
|
7 units on a scale
Standard Deviation 10.2
|
3 units on a scale
Standard Deviation 8.2
|
Adverse Events
Exercise Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wellness Waitlist Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place