Trial Outcomes & Findings for Active for Life: Chronic Obstructive Pulmonary Disease (NCT NCT03201198)
NCT ID: NCT03201198
Last Updated: 2024-04-17
Results Overview
The primary dependent variables are the time spent in physical activity (PA) as measured by Upright time monitored in each of the five intervals of the study over a 15-month period. PA will be measured for 7 consecutive days at each measurement using the ActivPal monitor. Each subject must have at least 4 of 7 valid monitoring days in each monitored period. The monitored periods are: baseline (T1), immediate post-intervention (T2), 3-month follow-up post intervention (T3), 6 month follow-up (T4), 12 month follow-up period (T5)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
182 participants
Primary outcome timeframe
7 days of continuous activity monitoring w as monitored on each participants at each of five test periods (T1-T5)
Results posted on
2024-04-17
Participant Flow
All subjects recruited had a diagnosis of COPD, were between the ages of 60-85 years, and had an FEV1%predicted less than 80%. Subjects recruited were stratified by gender and FEV1%predicted severity as part of the randomization process.
A total of 182 subjects were enrolled and randomized across both groups. Five subjects were not able to complete baseline assessment leaving 177 randomized subjects who completed baseline assessment.
Participant milestones
| Measure |
Active Life
The Active Life intervention includes structured walking, functional circuit training, stretching and behavior/educational components.
Active Life: The Active Life intervention focuses on increasing light physical activity (LPA) with 18 sessions over 10 weeks. Each session starts with 20 minutes of walking followed by functional circuit training. The intensity of the exercises and the speed of execution are adjusted to attain a rating of perceived exertion equal to somewhat hard to hard at the end of each circuit. Sessions end with stretching the major muscle groups. Sessions include a behavioral component (self-efficacy enhancing or confidence building) and health education. Subjects are encouraged to increase their total PA by at least 60 minutes a day, focusing on LPA. After completion of the structured intervention subjects will receive 11 5-minute phone coaching sessions and two booster sessions over the next 12 months.
|
Chair Exercises
The Chair exercise intervention includes chair exercises, behavioral relaxation and health education.
Chair exercises: Chair exercises focus on toning and stretching from a seated position with 18 sessions over 10 weeks. Each session includes 5 minutes of slow stretching, 20 minutes of faster paced exercises, 5 minutes of slower paced stretches, followed by 5-10 minutes of massage and imagery. Guided imagery is used to promote relaxation. Health education includes topics of interest to people with COPD such as basic lung physiology, pathophysiology of COPD, commonly used medications, breathing techniques, healthy eating and physical activity, relaxation, travel considerations, and energy conservation. After completion of the structured intervention subjects will receive 11 5-minute phone coaching sessions and two booster sessions over the next 12 months.
|
|---|---|---|
|
Overall Study
STARTED
|
92
|
90
|
|
Overall Study
COMPLETED
|
55
|
50
|
|
Overall Study
NOT COMPLETED
|
37
|
40
|
Reasons for withdrawal
| Measure |
Active Life
The Active Life intervention includes structured walking, functional circuit training, stretching and behavior/educational components.
Active Life: The Active Life intervention focuses on increasing light physical activity (LPA) with 18 sessions over 10 weeks. Each session starts with 20 minutes of walking followed by functional circuit training. The intensity of the exercises and the speed of execution are adjusted to attain a rating of perceived exertion equal to somewhat hard to hard at the end of each circuit. Sessions end with stretching the major muscle groups. Sessions include a behavioral component (self-efficacy enhancing or confidence building) and health education. Subjects are encouraged to increase their total PA by at least 60 minutes a day, focusing on LPA. After completion of the structured intervention subjects will receive 11 5-minute phone coaching sessions and two booster sessions over the next 12 months.
|
Chair Exercises
The Chair exercise intervention includes chair exercises, behavioral relaxation and health education.
Chair exercises: Chair exercises focus on toning and stretching from a seated position with 18 sessions over 10 weeks. Each session includes 5 minutes of slow stretching, 20 minutes of faster paced exercises, 5 minutes of slower paced stretches, followed by 5-10 minutes of massage and imagery. Guided imagery is used to promote relaxation. Health education includes topics of interest to people with COPD such as basic lung physiology, pathophysiology of COPD, commonly used medications, breathing techniques, healthy eating and physical activity, relaxation, travel considerations, and energy conservation. After completion of the structured intervention subjects will receive 11 5-minute phone coaching sessions and two booster sessions over the next 12 months.
|
|---|---|---|
|
Overall Study
Did not complete f reasons; lost to follow-up, subject withdrew, family illnesses, moving, etc.
|
35
|
37
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
Baseline Characteristics
Age was collected at the time of baseline spirometry. A total of 11 subjects did not have baseline spirometry completed. Eight subjects in the treatment arm and 3 subjects in the control arm did not have age reported at baseline assessment.
Baseline characteristics by cohort
| Measure |
Active Life
n=92 Participants
The Active Life intervention includes structured walking, functional circuit training, stretching and behavior/educational components.
Active Life: The Active Life intervention focuses on increasing light physical activity (LPA) with 18 sessions over 10 weeks. Each session starts with 20 minutes of walking followed by functional circuit training. The intensity of the exercises and the speed of execution are adjusted to attain a rating of perceived exertion equal to somewhat hard to hard at the end of each circuit. Sessions end with stretching the major muscle groups. Sessions include a behavioral component (self-efficacy enhancing or confidence building) and health education. Subjects are encouraged to increase their total PA by at least 60 minutes a day, focusing on LPA. After completion of the structured intervention subjects will receive 11 5-minute phone coaching sessions and two booster sessions over the next 12 months.
|
Chair Exercises
n=90 Participants
The Chair exercise intervention includes chair exercises, behavioral relaxation and health education.
Chair exercises: Chair exercises focus on toning and stretching from a seated position with 18 sessions over 10 weeks. Each session includes 5 minutes of slow stretching, 20 minutes of faster paced exercises, 5 minutes of slower paced stretches, followed by 5-10 minutes of massage and imagery. Guided imagery is used to promote relaxation. Health education includes topics of interest to people with COPD such as basic lung physiology, pathophysiology of COPD, commonly used medications, breathing techniques, healthy eating and physical activity, relaxation, travel considerations, and energy conservation. After completion of the structured intervention subjects will receive 11 5-minute phone coaching sessions and two booster sessions over the next 12 months.
|
Total
n=182 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.5 years
STANDARD_DEVIATION 7.8 • n=82 Participants • Age was collected at the time of baseline spirometry. A total of 11 subjects did not have baseline spirometry completed. Eight subjects in the treatment arm and 3 subjects in the control arm did not have age reported at baseline assessment.
|
70.3 years
STANDARD_DEVIATION 8.5 • n=84 Participants • Age was collected at the time of baseline spirometry. A total of 11 subjects did not have baseline spirometry completed. Eight subjects in the treatment arm and 3 subjects in the control arm did not have age reported at baseline assessment.
|
69.4 years
STANDARD_DEVIATION 8.1 • n=166 Participants • Age was collected at the time of baseline spirometry. A total of 11 subjects did not have baseline spirometry completed. Eight subjects in the treatment arm and 3 subjects in the control arm did not have age reported at baseline assessment.
|
|
Sex: Female, Male
Female
|
37 Participants
n=82 Participants • Gender was not reported in 11 subjects during baseline spirometry. 8 subjects in the treatment arm and 3 subjects in the control arm
|
38 Participants
n=84 Participants • Gender was not reported in 11 subjects during baseline spirometry. 8 subjects in the treatment arm and 3 subjects in the control arm
|
75 Participants
n=166 Participants • Gender was not reported in 11 subjects during baseline spirometry. 8 subjects in the treatment arm and 3 subjects in the control arm
|
|
Sex: Female, Male
Male
|
45 Participants
n=82 Participants • Gender was not reported in 11 subjects during baseline spirometry. 8 subjects in the treatment arm and 3 subjects in the control arm
|
46 Participants
n=84 Participants • Gender was not reported in 11 subjects during baseline spirometry. 8 subjects in the treatment arm and 3 subjects in the control arm
|
91 Participants
n=166 Participants • Gender was not reported in 11 subjects during baseline spirometry. 8 subjects in the treatment arm and 3 subjects in the control arm
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=92 Participants • Race not recorded for 12 subjects at baseline. 5 participants did not complete baseline assessments. 17 total unknown
|
0 Participants
n=90 Participants • Race not recorded for 12 subjects at baseline. 5 participants did not complete baseline assessments. 17 total unknown
|
2 Participants
n=182 Participants • Race not recorded for 12 subjects at baseline. 5 participants did not complete baseline assessments. 17 total unknown
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=92 Participants • Race not recorded for 12 subjects at baseline. 5 participants did not complete baseline assessments. 17 total unknown
|
2 Participants
n=90 Participants • Race not recorded for 12 subjects at baseline. 5 participants did not complete baseline assessments. 17 total unknown
|
3 Participants
n=182 Participants • Race not recorded for 12 subjects at baseline. 5 participants did not complete baseline assessments. 17 total unknown
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=92 Participants • Race not recorded for 12 subjects at baseline. 5 participants did not complete baseline assessments. 17 total unknown
|
0 Participants
n=90 Participants • Race not recorded for 12 subjects at baseline. 5 participants did not complete baseline assessments. 17 total unknown
|
0 Participants
n=182 Participants • Race not recorded for 12 subjects at baseline. 5 participants did not complete baseline assessments. 17 total unknown
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=92 Participants • Race not recorded for 12 subjects at baseline. 5 participants did not complete baseline assessments. 17 total unknown
|
13 Participants
n=90 Participants • Race not recorded for 12 subjects at baseline. 5 participants did not complete baseline assessments. 17 total unknown
|
22 Participants
n=182 Participants • Race not recorded for 12 subjects at baseline. 5 participants did not complete baseline assessments. 17 total unknown
|
|
Race (NIH/OMB)
White
|
70 Participants
n=92 Participants • Race not recorded for 12 subjects at baseline. 5 participants did not complete baseline assessments. 17 total unknown
|
68 Participants
n=90 Participants • Race not recorded for 12 subjects at baseline. 5 participants did not complete baseline assessments. 17 total unknown
|
138 Participants
n=182 Participants • Race not recorded for 12 subjects at baseline. 5 participants did not complete baseline assessments. 17 total unknown
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=92 Participants • Race not recorded for 12 subjects at baseline. 5 participants did not complete baseline assessments. 17 total unknown
|
0 Participants
n=90 Participants • Race not recorded for 12 subjects at baseline. 5 participants did not complete baseline assessments. 17 total unknown
|
0 Participants
n=182 Participants • Race not recorded for 12 subjects at baseline. 5 participants did not complete baseline assessments. 17 total unknown
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=92 Participants • Race not recorded for 12 subjects at baseline. 5 participants did not complete baseline assessments. 17 total unknown
|
7 Participants
n=90 Participants • Race not recorded for 12 subjects at baseline. 5 participants did not complete baseline assessments. 17 total unknown
|
17 Participants
n=182 Participants • Race not recorded for 12 subjects at baseline. 5 participants did not complete baseline assessments. 17 total unknown
|
|
FEV1%Predicted
|
53.77 Percent of actual to predicted
STANDARD_DEVIATION 15.6 • n=82 Participants • Eleven subjects (8 in treatment arm, 3 in control arm) did not report baseline spirometry
|
56.99 Percent of actual to predicted
STANDARD_DEVIATION 13.5 • n=84 Participants • Eleven subjects (8 in treatment arm, 3 in control arm) did not report baseline spirometry
|
55.4 Percent of actual to predicted
STANDARD_DEVIATION 14.5 • n=166 Participants • Eleven subjects (8 in treatment arm, 3 in control arm) did not report baseline spirometry
|
PRIMARY outcome
Timeframe: 7 days of continuous activity monitoring w as monitored on each participants at each of five test periods (T1-T5)Population: Number of participants who were analyzed at each time period (T1-T5) varied due to participants withdrawing, not being available to keep their test appointments, illness, etc. T1=baseline, T2=testing at completion of intervention, T3= 3 months following intervention, T4=6 months following intervention, T5=12 months following intervention
The primary dependent variables are the time spent in physical activity (PA) as measured by Upright time monitored in each of the five intervals of the study over a 15-month period. PA will be measured for 7 consecutive days at each measurement using the ActivPal monitor. Each subject must have at least 4 of 7 valid monitoring days in each monitored period. The monitored periods are: baseline (T1), immediate post-intervention (T2), 3-month follow-up post intervention (T3), 6 month follow-up (T4), 12 month follow-up period (T5)
Outcome measures
| Measure |
Active Life
n=90 Participants
The Active Life intervention includes structured walking, functional circuit training, stretching and behavior/educational components.
Active Life: The Active Life intervention focuses on increasing light physical activity (LPA) with 18 sessions over 10 weeks. Each session starts with 20 minutes of walking followed by functional circuit training. The intensity of the exercises and the speed of execution are adjusted to attain a rating of perceived exertion equal to somewhat hard to hard at the end of each circuit. Sessions end with stretching the major muscle groups. Sessions include a behavioral component (self-efficacy enhancing or confidence building) and health education. Subjects are encouraged to increase their total PA by at least 60 minutes a day, focusing on LPA. After completion of the structured intervention subjects will receive 11 5-minute phone coaching sessions and two booster sessions over the next 12 months.
|
Chair Exercises
n=87 Participants
The Chair exercise intervention includes chair exercises, behavioral relaxation and health education.
Chair exercises: Chair exercises focus on toning and stretching from a seated position with 18 sessions over 10 weeks. Each session includes 5 minutes of slow stretching, 20 minutes of faster paced exercises, 5 minutes of slower paced stretches, followed by 5-10 minutes of massage and imagery. Guided imagery is used to promote relaxation. Health education includes topics of interest to people with COPD such as basic lung physiology, pathophysiology of COPD, commonly used medications, breathing techniques, healthy eating and physical activity, relaxation, travel considerations, and energy conservation. After completion of the structured intervention subjects will receive 11 5-minute phone coaching sessions and two booster sessions over the next 12 months.
|
|---|---|---|
|
Time Spent in Physical Activity as Measured by Upright Time (Minutes Per Day) Monitored by ActivPal Monitor
Baseline-T1
|
278 minutes per day
Standard Deviation 144
|
269 minutes per day
Standard Deviation 138
|
|
Time Spent in Physical Activity as Measured by Upright Time (Minutes Per Day) Monitored by ActivPal Monitor
T2
|
293 minutes per day
Standard Deviation 138
|
285 minutes per day
Standard Deviation 130
|
|
Time Spent in Physical Activity as Measured by Upright Time (Minutes Per Day) Monitored by ActivPal Monitor
T3
|
293 minutes per day
Standard Deviation 156
|
279 minutes per day
Standard Deviation 138
|
|
Time Spent in Physical Activity as Measured by Upright Time (Minutes Per Day) Monitored by ActivPal Monitor
T4
|
282 minutes per day
Standard Deviation 154
|
257 minutes per day
Standard Deviation 99
|
|
Time Spent in Physical Activity as Measured by Upright Time (Minutes Per Day) Monitored by ActivPal Monitor
T5
|
277 minutes per day
Standard Deviation 145
|
299 minutes per day
Standard Deviation 146
|
PRIMARY outcome
Timeframe: 7 days of continuous activity monitoring at each intervalPopulation: Participant/unit totals differ from overall number analyzed due to invalid or incomplete monitoring of subjects or subjects withdrawals between intervals.
The primary dependent variable are the time spent in sedentary activity as measured as Sedentary Activity (SA) time monitored in each of the five intervals of the study over a 15-month period. SA will be measured for 7 consecutive days at each interval using the ActivPal monitor. Each subject must have at least 4 of 7 valid monitoring days in each monitored period. The monitored periods are: baseline (T1), immediate post-intervention (T2), 3-month follow-up post intervention (T3), 6 month follow-up (T4), 12 month follow-up period (T5)
Outcome measures
| Measure |
Active Life
n=90 Participants
The Active Life intervention includes structured walking, functional circuit training, stretching and behavior/educational components.
Active Life: The Active Life intervention focuses on increasing light physical activity (LPA) with 18 sessions over 10 weeks. Each session starts with 20 minutes of walking followed by functional circuit training. The intensity of the exercises and the speed of execution are adjusted to attain a rating of perceived exertion equal to somewhat hard to hard at the end of each circuit. Sessions end with stretching the major muscle groups. Sessions include a behavioral component (self-efficacy enhancing or confidence building) and health education. Subjects are encouraged to increase their total PA by at least 60 minutes a day, focusing on LPA. After completion of the structured intervention subjects will receive 11 5-minute phone coaching sessions and two booster sessions over the next 12 months.
|
Chair Exercises
n=87 Participants
The Chair exercise intervention includes chair exercises, behavioral relaxation and health education.
Chair exercises: Chair exercises focus on toning and stretching from a seated position with 18 sessions over 10 weeks. Each session includes 5 minutes of slow stretching, 20 minutes of faster paced exercises, 5 minutes of slower paced stretches, followed by 5-10 minutes of massage and imagery. Guided imagery is used to promote relaxation. Health education includes topics of interest to people with COPD such as basic lung physiology, pathophysiology of COPD, commonly used medications, breathing techniques, healthy eating and physical activity, relaxation, travel considerations, and energy conservation. After completion of the structured intervention subjects will receive 11 5-minute phone coaching sessions and two booster sessions over the next 12 months.
|
|---|---|---|
|
Time Spent in Sedentary Behavior
Baseline (T1)
|
683 average minutes per day
Standard Deviation 180
|
698 average minutes per day
Standard Deviation 187
|
|
Time Spent in Sedentary Behavior
T2
|
661 average minutes per day
Standard Deviation 173
|
658 average minutes per day
Standard Deviation 177
|
|
Time Spent in Sedentary Behavior
T3
|
661 average minutes per day
Standard Deviation 180
|
672 average minutes per day
Standard Deviation 180
|
|
Time Spent in Sedentary Behavior
T4
|
683 average minutes per day
Standard Deviation 182
|
681 average minutes per day
Standard Deviation 160
|
|
Time Spent in Sedentary Behavior
T5
|
671 average minutes per day
Standard Deviation 174
|
639 average minutes per day
Standard Deviation 169
|
SECONDARY outcome
Timeframe: Measured at baseline, end of 10 week intervention and at 3, 6, and 12 months after the completion of the 10 week interventionPopulation: Participant/unit totals differ from overall number analyzed due to invalid or incomplete testing of subjects or subjects withdrawals between intervals.
This is the maximal distance a subject can walk during six minutes.
Outcome measures
| Measure |
Active Life
n=90 Participants
The Active Life intervention includes structured walking, functional circuit training, stretching and behavior/educational components.
Active Life: The Active Life intervention focuses on increasing light physical activity (LPA) with 18 sessions over 10 weeks. Each session starts with 20 minutes of walking followed by functional circuit training. The intensity of the exercises and the speed of execution are adjusted to attain a rating of perceived exertion equal to somewhat hard to hard at the end of each circuit. Sessions end with stretching the major muscle groups. Sessions include a behavioral component (self-efficacy enhancing or confidence building) and health education. Subjects are encouraged to increase their total PA by at least 60 minutes a day, focusing on LPA. After completion of the structured intervention subjects will receive 11 5-minute phone coaching sessions and two booster sessions over the next 12 months.
|
Chair Exercises
n=87 Participants
The Chair exercise intervention includes chair exercises, behavioral relaxation and health education.
Chair exercises: Chair exercises focus on toning and stretching from a seated position with 18 sessions over 10 weeks. Each session includes 5 minutes of slow stretching, 20 minutes of faster paced exercises, 5 minutes of slower paced stretches, followed by 5-10 minutes of massage and imagery. Guided imagery is used to promote relaxation. Health education includes topics of interest to people with COPD such as basic lung physiology, pathophysiology of COPD, commonly used medications, breathing techniques, healthy eating and physical activity, relaxation, travel considerations, and energy conservation. After completion of the structured intervention subjects will receive 11 5-minute phone coaching sessions and two booster sessions over the next 12 months.
|
|---|---|---|
|
Six-minute Walk Test
Baseline (T1)
|
1241 Feet
Standard Deviation 306
|
1202 Feet
Standard Deviation 324
|
|
Six-minute Walk Test
T2
|
1368 Feet
Standard Deviation 254
|
1234 Feet
Standard Deviation 339
|
|
Six-minute Walk Test
T3
|
1320 Feet
Standard Deviation 343
|
1281 Feet
Standard Deviation 295
|
|
Six-minute Walk Test
T4
|
1339 Feet
Standard Deviation 280
|
1272 Feet
Standard Deviation 294
|
|
Six-minute Walk Test
T5
|
1311 Feet
Standard Deviation 267
|
1264 Feet
Standard Deviation 307
|
Adverse Events
Active Life
Serious events: 7 serious events
Other events: 17 other events
Deaths: 4 deaths
Chair Exercises
Serious events: 5 serious events
Other events: 12 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Active Life
n=82 participants at risk
The Active Life intervention includes structured walking, functional circuit training, stretching and behavior/educational components.
Active Life: The Active Life intervention focuses on increasing light physical activity (LPA) with 18 sessions over 10 weeks. Each session starts with 20 minutes of walking followed by functional circuit training. The intensity of the exercises and the speed of execution are adjusted to attain a rating of perceived exertion equal to somewhat hard to hard at the end of each circuit. Sessions end with stretching the major muscle groups. Sessions include a behavioral component (self-efficacy enhancing or confidence building) and health education. Subjects are encouraged to increase their total PA by at least 60 minutes a day, focusing on LPA. After completion of the structured intervention subjects will receive 11 5-minute phone coaching sessions and two booster sessions over the next 12 months.
|
Chair Exercises
n=84 participants at risk
The Chair exercise intervention includes chair exercises, behavioral relaxation and health education.
Chair exercises: Chair exercises focus on toning and stretching from a seated position with 18 sessions over 10 weeks. Each session includes 5 minutes of slow stretching, 20 minutes of faster paced exercises, 5 minutes of slower paced stretches, followed by 5-10 minutes of massage and imagery. Guided imagery is used to promote relaxation. Health education includes topics of interest to people with COPD such as basic lung physiology, pathophysiology of COPD, commonly used medications, breathing techniques, healthy eating and physical activity, relaxation, travel considerations, and energy conservation. After completion of the structured intervention subjects will receive 11 5-minute phone coaching sessions and two booster sessions over the next 12 months.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
acute exacerbation requiring hospitalization
|
8.5%
7/82 • Number of events 7 • 15 months for each subject enrolled who completed the entire study period
|
6.0%
5/84 • Number of events 5 • 15 months for each subject enrolled who completed the entire study period
|
Other adverse events
| Measure |
Active Life
n=82 participants at risk
The Active Life intervention includes structured walking, functional circuit training, stretching and behavior/educational components.
Active Life: The Active Life intervention focuses on increasing light physical activity (LPA) with 18 sessions over 10 weeks. Each session starts with 20 minutes of walking followed by functional circuit training. The intensity of the exercises and the speed of execution are adjusted to attain a rating of perceived exertion equal to somewhat hard to hard at the end of each circuit. Sessions end with stretching the major muscle groups. Sessions include a behavioral component (self-efficacy enhancing or confidence building) and health education. Subjects are encouraged to increase their total PA by at least 60 minutes a day, focusing on LPA. After completion of the structured intervention subjects will receive 11 5-minute phone coaching sessions and two booster sessions over the next 12 months.
|
Chair Exercises
n=84 participants at risk
The Chair exercise intervention includes chair exercises, behavioral relaxation and health education.
Chair exercises: Chair exercises focus on toning and stretching from a seated position with 18 sessions over 10 weeks. Each session includes 5 minutes of slow stretching, 20 minutes of faster paced exercises, 5 minutes of slower paced stretches, followed by 5-10 minutes of massage and imagery. Guided imagery is used to promote relaxation. Health education includes topics of interest to people with COPD such as basic lung physiology, pathophysiology of COPD, commonly used medications, breathing techniques, healthy eating and physical activity, relaxation, travel considerations, and energy conservation. After completion of the structured intervention subjects will receive 11 5-minute phone coaching sessions and two booster sessions over the next 12 months.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Exercise intolerance due to pain or injury, non-serious
|
7.3%
6/82 • Number of events 6 • 15 months for each subject enrolled who completed the entire study period
|
6.0%
5/84 • Number of events 5 • 15 months for each subject enrolled who completed the entire study period
|
|
Injury, poisoning and procedural complications
Fall with non-serious injury
|
13.4%
11/82 • Number of events 11 • 15 months for each subject enrolled who completed the entire study period
|
8.3%
7/84 • Number of events 7 • 15 months for each subject enrolled who completed the entire study period
|
Additional Information
Dr. Janet Larson
University of Michigan School of Nursing
Phone: 7346470126
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place