Trial Outcomes & Findings for A "Stand Up and Move More" Intervention for Older Adults (NCT NCT03412084)
NCT ID: NCT03412084
Last Updated: 2020-12-16
Results Overview
Participants wore monitors during the day to assess total sitting time/day
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
84 participants
Primary outcome timeframe
Baseline, 4 weeks, 12 weeks
Results posted on
2020-12-16
Participant Flow
Participant milestones
| Measure |
Stand up Intervention
four week behavioral intervention based on self-regulation theory which is designed to facilitate the development of action plans to break up prolonged sitting
Stand up and move more: 4 week behavioral intervention involving the development and implementation of action plans
|
Control
No behavioral intervention - the control group will go about their daily life, but come in for assessments at the same time points as the intervention group
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
36
|
|
Overall Study
COMPLETED
|
44
|
35
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Stand up Intervention
four week behavioral intervention based on self-regulation theory which is designed to facilitate the development of action plans to break up prolonged sitting
Stand up and move more: 4 week behavioral intervention involving the development and implementation of action plans
|
Control
No behavioral intervention - the control group will go about their daily life, but come in for assessments at the same time points as the intervention group
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Participant moved
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
A "Stand Up and Move More" Intervention for Older Adults
Baseline characteristics by cohort
| Measure |
Stand up Intervention
n=48 Participants
four week behavioral intervention based on self-regulation theory which is designed to facilitate the development of action plans to break up prolonged sitting
Stand up and move more: 4 week behavioral intervention involving the development and implementation of action plans
|
Control
n=36 Participants
No behavioral intervention - the control group will go about their daily life, but come in for assessments at the same time points as the intervention group
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72 years
STANDARD_DEVIATION 9 • n=5 Participants
|
73.5 years
STANDARD_DEVIATION 6 • n=7 Participants
|
73 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
42 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=5 Participants
|
36 participants
n=7 Participants
|
84 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 weeks, 12 weeksPopulation: The number of participants analyzed differs for each time point due to participant availability, attrition, and not all participants wore the monitors per protocol for each visit (10 hours/day for a full week each time point).
Participants wore monitors during the day to assess total sitting time/day
Outcome measures
| Measure |
Stand up Intervention
n=48 Participants
four week behavioral intervention based on self-regulation theory which is designed to facilitate the development of action plans to break up prolonged sitting
Stand up and move more: 4 week behavioral intervention involving the development and implementation of action plans
|
Control
n=36 Participants
No behavioral intervention - the control group will go about their daily life, but come in for assessments at the same time points as the intervention group
|
|---|---|---|
|
Total Sedentary Time Per Day
Baseline
|
618 minute/day
Standard Deviation 119
|
660 minute/day
Standard Deviation 153
|
|
Total Sedentary Time Per Day
4 weeks
|
564 minute/day
Standard Deviation 119
|
650 minute/day
Standard Deviation 117
|
|
Total Sedentary Time Per Day
12 weeks
|
602 minute/day
Standard Deviation 116
|
617 minute/day
Standard Deviation 120
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 12 weeksPopulation: The number of participants analyzed differs for each time point due to participant availability and attrition.
The SPPB is an assessment of physical limitations. It combines scores from a balance test, gait speed test, and a chair stand test. The total possible range of scores is 1-12, higher scores indicate better function/less functional limitations.
Outcome measures
| Measure |
Stand up Intervention
n=48 Participants
four week behavioral intervention based on self-regulation theory which is designed to facilitate the development of action plans to break up prolonged sitting
Stand up and move more: 4 week behavioral intervention involving the development and implementation of action plans
|
Control
n=36 Participants
No behavioral intervention - the control group will go about their daily life, but come in for assessments at the same time points as the intervention group
|
|---|---|---|
|
Short Physical Performance Battery (SPPB) Score
Baseline
|
8.05 score on a scale
Standard Deviation 2.46
|
7.65 score on a scale
Standard Deviation 2.60
|
|
Short Physical Performance Battery (SPPB) Score
4 weeks
|
9.29 score on a scale
Standard Deviation 2.65
|
7.44 score on a scale
Standard Deviation 2.31
|
|
Short Physical Performance Battery (SPPB) Score
12 weeks
|
10.45 score on a scale
Standard Deviation 2.01
|
8.00 score on a scale
Standard Deviation 2.81
|
Adverse Events
Stand up Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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