Trial Outcomes & Findings for Reducing Sedentary Behavior vs. Increasing Physical Activity in Older Adults (NCT NCT02146001)

Results Overview

Subjects will wear a BodyMedia SenseWearPro armband for 7 days during all waking hours at baseline and 12 weeks. This multi-sensor armband will give an estimate of time spent in sedentary behavior over a 1 week period. Sedentary time will be averaged across days and reported as hours per day.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

38 participants

Primary outcome timeframe

Change from baseline to 12 weeks

Results posted on

2016-08-19

Participant Flow

241 subjects were screened. Of these 190 did not meet inclusion criteria, 13 declined to participate, and 38 were eligible and enrolled in the study.

Participant milestones

Participant milestones
Measure	Get Active Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity	Sit Less Targeting 1 hour less of sedentary time per day
Overall Study STARTED	19	19
Overall Study COMPLETED	19	19
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reducing Sedentary Behavior vs. Increasing Physical Activity in Older Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Get Active n=19 Participants Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity	Sit Less n=19 Participants Targeting 1 hour less of sedentary time per day	Total n=38 Participants Total of all reporting groups
Age, Continuous	67.3 years STANDARD_DEVIATION 6.5 • n=99 Participants	68.5 years STANDARD_DEVIATION 6.5 • n=107 Participants	67.9 years STANDARD_DEVIATION 6.6 • n=206 Participants
Sex: Female, Male Female	13 Participants n=99 Participants	14 Participants n=107 Participants	27 Participants n=206 Participants
Sex: Female, Male Male	6 Participants n=99 Participants	5 Participants n=107 Participants	11 Participants n=206 Participants
Race/Ethnicity, Customized White	14 participants n=99 Participants	18 participants n=107 Participants	32 participants n=206 Participants
Race/Ethnicity, Customized Non-white	5 participants n=99 Participants	1 participants n=107 Participants	6 participants n=206 Participants
Body Mass Index, continuous	28.9 kg/m^2 STANDARD_DEVIATION 6.3 • n=99 Participants	28.3 kg/m^2 STANDARD_DEVIATION 4.8 • n=107 Participants	28.6 kg/m^2 STANDARD_DEVIATION 5.5 • n=206 Participants

PRIMARY outcome

Timeframe: Change from baseline to 12 weeks

Subjects will wear a BodyMedia SenseWearPro armband for 7 days during all waking hours at baseline and 12 weeks. This multi-sensor armband will give an estimate of time spent in sedentary behavior over a 1 week period. Sedentary time will be averaged across days and reported as hours per day.

Outcome measures

Outcome measures
Measure	Get Active n=19 Participants Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity	Sit Less n=19 Participants Targeting 1 hour less of sedentary time per day
Change in Objectively Monitored Sedentary Behavior	-0.1 hours/day Standard Error 0.4	0.6 hours/day Standard Error 0.3

SECONDARY outcome

Timeframe: Change from baseline to 12 weeks

Physical function will be assessed by the Short Physical Performance Battery including a chair stand test (timed test to stand up and down 5 times without using hands), a 4-meter walk test for gait speed, and a standing balance test. Standard scoring of the SPPB was used where each test contributes up to 4 points x 3 tests and the score can, therefore, range from 0 (worst) to 12 (best).

Outcome measures

Outcome measures
Measure	Get Active n=19 Participants Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity	Sit Less n=19 Participants Targeting 1 hour less of sedentary time per day
Change in Physical Function (Short Physical Performance Battery [SPPB])	0.2 points Standard Error 0.2	0.5 points Standard Error 0.3

SECONDARY outcome

Timeframe: Change from baseline to 12 weeks

Subjects will wear a BodyMedia SenseWearPro armband for 7 days during all waking hours at baseline and 12 weeks (same as for the primary outcome of sedentary behavior). This multi-sensor armband will give an estimate of time spent in moderate-to-vigorous physical activity over a 1 week period.

Outcome measures

Outcome measures
Measure	Get Active n=19 Participants Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity	Sit Less n=19 Participants Targeting 1 hour less of sedentary time per day
Change in Objectively-monitored Moderate-to-vigorous Physical Activity	75 bouted minutes/week Standard Error 22	-7 bouted minutes/week Standard Error 25

Adverse Events

Get Active

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sit Less

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

Dr. Bethany Barone Gibbs

University of Pittsburgh

Phone: 412-383-4002

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place