Trial Outcomes & Findings for Collaborative-care Rehabilitation After Dysvascular Amputation (NCT NCT01929018)
NCT ID: NCT01929018
Last Updated: 2019-08-14
Results Overview
Performance-based physical function test able to predict falls for people with lower limb amputation. The TUG test time is taken from rising from a chair, walking 3 meters, turning, walking back and sitting down. Continuous scale; higher time indicates lower physical function, higher likelihood of falls.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
Baseline, 12-weeks, and 24 weeks
Results posted on
2019-08-14
Participant Flow
No significant study events occurred after participants were enrolled, but before they were assigned to a study group.
Participant milestones
| Measure |
Exercise, Activity, and Self-management
Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.
Exercise: Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.
Walking Program: A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.
Health Self-Management Support: Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.
|
Home and Phone Visit
No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Exercise, Activity, and Self-management
Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.
Exercise: Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.
Walking Program: A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.
Health Self-Management Support: Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.
|
Home and Phone Visit
No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Hospitalization
|
0
|
1
|
Baseline Characteristics
Collaborative-care Rehabilitation After Dysvascular Amputation
Baseline characteristics by cohort
| Measure |
Exercise, Activity, and Self-management
n=19 Participants
Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.
Exercise: Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.
Walking Program: A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.
Health Self-Management Support: Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.
|
Home and Phone Visit
n=19 Participants
No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 Years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
65 Years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
63.6 Years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Site of Rehab, n, Veterans Administration Medical Center
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
BMI, kg/m2
|
31 kg/m^2
STANDARD_DEVIATION 10.6 • n=5 Participants
|
30 kg/m^2
STANDARD_DEVIATION 6.3 • n=7 Participants
|
31 kg/m^2
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Time Since Amputation, weeks
|
16 weeks
STANDARD_DEVIATION 6.5 • n=5 Participants
|
20 weeks
STANDARD_DEVIATION 6.4 • n=7 Participants
|
18 weeks
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Geriatric Depression Scale, score out of 15
|
2.8 units on a scale
STANDARD_DEVIATION 3.2 • n=5 Participants
|
3.2 units on a scale
STANDARD_DEVIATION 2.6 • n=7 Participants
|
3.0 units on a scale
STANDARD_DEVIATION 2.9 • n=5 Participants
|
|
Mini Mental Status Exam, score out of 30
|
28.6 units on a scale
STANDARD_DEVIATION 1.2 • n=5 Participants
|
27.5 units on a scale
STANDARD_DEVIATION 2.5 • n=7 Participants
|
28.2 units on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Intrinsic Motivation Inventory, score out of 7
|
5.6 units on a scale
STANDARD_DEVIATION 1.0 • n=5 Participants
|
5.6 units on a scale
STANDARD_DEVIATION 1.1 • n=7 Participants
|
5.6 units on a scale
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
Chakrabarty Grade, score out of 100
|
77.3 units on a scale
STANDARD_DEVIATION 16.2 • n=5 Participants
|
82.4 units on a scale
STANDARD_DEVIATION 15.0 • n=7 Participants
|
79.8 units on a scale
STANDARD_DEVIATION 15.6 • n=5 Participants
|
|
Comorbidity Index, score out of 20
|
6.1 units on a scale
STANDARD_DEVIATION 2.7 • n=5 Participants
|
7.1 units on a scale
STANDARD_DEVIATION 2.3 • n=7 Participants
|
6.6 units on a scale
STANDARD_DEVIATION 2.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12-weeks, and 24 weeksPopulation: 38 (35 men, 3 women; 19 INT, 19 CTL) enrolled. 1 INT and 1 CTL lost to follow-up. 36 participants assessed at all time points. Two CTL at 12 weeks and 2 CTL,1 INT at 24 weeks completed questionnaires only.
Performance-based physical function test able to predict falls for people with lower limb amputation. The TUG test time is taken from rising from a chair, walking 3 meters, turning, walking back and sitting down. Continuous scale; higher time indicates lower physical function, higher likelihood of falls.
Outcome measures
| Measure |
Exercise, Activity, and Self-management
n=18 Participants
Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.
Exercise: Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.
Walking Program: A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.
Health Self-Management Support: Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.
|
Home and Phone Visit
n=18 Participants
No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.
|
|---|---|---|
|
Timed Up-and-Go Test
Baseline
|
19.4 seconds
Interval 14.8 to 23.9
|
20.7 seconds
Interval 15.6 to 25.7
|
|
Timed Up-and-Go Test
12-Week
|
18.2 seconds
Interval 13.4 to 22.9
|
18.8 seconds
Interval 13.6 to 24.1
|
|
Timed Up-and-Go Test
24-week
|
16.7 seconds
Interval 12.1 to 21.3
|
21.3 seconds
Interval 16.0 to 26.7
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, and 24 weeksPopulation: 38 (35 men, 3 women; 19 INT, 19 CTL) enrolled. 1 INT and 1 CTL lost to follow-up. 36 participants assessed at all time points. Two CTL at 12 weeks and 2 CTL,1 INT at 24 weeks completed questionnaires only.
Performance-based physical function test measures total number of meters walked in two minutes on a level walkway.
Outcome measures
| Measure |
Exercise, Activity, and Self-management
n=18 Participants
Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.
Exercise: Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.
Walking Program: A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.
Health Self-Management Support: Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.
|
Home and Phone Visit
n=18 Participants
No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.
|
|---|---|---|
|
Two-Minute Walk Test
Baseline
|
86.9 meters
Interval 76.9 to 96.9
|
84.4 meters
Interval 73.2 to 95.6
|
|
Two-Minute Walk Test
12-Week
|
88.5 meters
Interval 77.6 to 99.3
|
83.3 meters
Interval 71.3 to 95.3
|
|
Two-Minute Walk Test
24-Week
|
99.8 meters
Interval 89.6 to 110.0
|
84.0 meters
Interval 72.0 to 96.1
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, and 24 weeksPopulation: 38 (35 men, 3 women; 19 INT, 19 CTL) enrolled. 1 INT and 1 CTL lost to follow-up. 36 participants assessed at all time points. Two CTL at 12 weeks and 2 CTL,1 INT at 24 weeks completed questionnaires only.
Performance-based physical function test measures the time to walk 5 meters at the participant's "normal, everyday pace".
Outcome measures
| Measure |
Exercise, Activity, and Self-management
n=18 Participants
Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.
Exercise: Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.
Walking Program: A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.
Health Self-Management Support: Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.
|
Home and Phone Visit
n=18 Participants
No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.
|
|---|---|---|
|
Five Meter Walk Test
Baseline
|
0.78 meters/second
Interval 0.69 to 0.88
|
0.76 meters/second
Interval 0.66 to 0.87
|
|
Five Meter Walk Test
12-Week
|
0.96 meters/second
Interval 0.86 to 1.06
|
0.83 meters/second
Interval 0.71 to 0.94
|
|
Five Meter Walk Test
24-Week
|
0.97 meters/second
Interval 0.87 to 1.06
|
0.86 meters/second
Interval 0.75 to 0.98
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, and 24 weeksPopulation: 38 (35 men, 3 women; 19 INT, 19 CTL) enrolled. 1 INT and 1 CTL lost to follow-up. 36 participants assessed at all time points. Two CTL at 12 weeks and 2 CTL,1 INT at 24 weeks completed questionnaires only.
Self-report physical function questionnaire measures capacity to perform a list of specific functional tasks (e.g., walking upstairs, getting in and out of a vehicle. Scores range from being unable or hardly able (0) to having no problems (4). An average score across the 12-item questionnaire was used in the analysis. Lower numbers indicate less difficulty.
Outcome measures
| Measure |
Exercise, Activity, and Self-management
n=18 Participants
Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.
Exercise: Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.
Walking Program: A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.
Health Self-Management Support: Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.
|
Home and Phone Visit
n=18 Participants
No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.
|
|---|---|---|
|
Prosthesis Evaluation Questionnaire - Mobility Section
Baseline
|
2.2 units on a scale
Interval 1.7 to 2.8
|
2.1 units on a scale
Interval 1.5 to 2.8
|
|
Prosthesis Evaluation Questionnaire - Mobility Section
12-Week
|
2.6 units on a scale
Interval 2.0 to 3.2
|
2.0 units on a scale
Interval 1.3 to 2.6
|
|
Prosthesis Evaluation Questionnaire - Mobility Section
24-Week
|
2.7 units on a scale
Interval 2.1 to 3.3
|
2.4 units on a scale
Interval 1.7 to 3.0
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, and 24 weeksPopulation: 38 (35 men, 3 women; 19 INT, 19 CTL) enrolled. 1 INT and 1 CTL lost to follow-up. 36 participants assessed at all time points. Two CTL at 12 weeks and 2 CTL,1 INT at 24 weeks completed questionnaires only.
Self-report physical function questionnaire. The outcome is the sum of scores from each item (min 0, max 12). A higher score indicates higher self-report of physical function with the prosthesis.
Outcome measures
| Measure |
Exercise, Activity, and Self-management
n=18 Participants
Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.
Exercise: Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.
Walking Program: A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.
Health Self-Management Support: Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.
|
Home and Phone Visit
n=18 Participants
No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.
|
|---|---|---|
|
Houghton Scale
Baseline
|
0.64 units on a scale
Standard Deviation 0.15
|
0.62 units on a scale
Standard Deviation 0.23
|
|
Houghton Scale
12-Week
|
0.69 units on a scale
Standard Deviation 0.28
|
0.69 units on a scale
Standard Deviation 0.24
|
|
Houghton Scale
24-Week
|
0.77 units on a scale
Standard Deviation 0.18
|
0.65 units on a scale
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, and 24 weeksPopulation: 38 (35 men, 3 women; 19 INT, 19 CTL) enrolled. 1 INT and 1 CTL lost to follow-up. 36 participants assessed at all time points. Two CTL at 12 weeks and 2 CTL,1 INT at 24 weeks completed questionnaires only.
Self-report physical function questionnaire. The outcome is the average score for up to five participant-identified activities on a scale from 0-10 (min 0, max 10). Higher score indicates greater ability to perform functional activities.
Outcome measures
| Measure |
Exercise, Activity, and Self-management
n=18 Participants
Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.
Exercise: Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.
Walking Program: A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.
Health Self-Management Support: Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.
|
Home and Phone Visit
n=18 Participants
No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.
|
|---|---|---|
|
Patient-Specific Function Scale
Baseline
|
3.3 units on a scale
Standard Deviation 1.8
|
3.5 units on a scale
Standard Deviation 1.9
|
|
Patient-Specific Function Scale
12 weeks
|
5.7 units on a scale
Standard Deviation 2.6
|
5.1 units on a scale
Standard Deviation 2.3
|
|
Patient-Specific Function Scale
24 weeks
|
6.9 units on a scale
Standard Deviation 2.3
|
5.3 units on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, and 24 weeksPopulation: 38 (35 men, 3 women; 19 INT, 19 CTL) enrolled. 1 INT and 1 CTL lost to follow-up. 36 participants assessed at all time points. Two CTL at 12 weeks and 2 CTL,1 INT at 24 weeks completed questionnaires only.
Instrumented physical activity measure, average step counts per day
Outcome measures
| Measure |
Exercise, Activity, and Self-management
n=18 Participants
Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.
Exercise: Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.
Walking Program: A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.
Health Self-Management Support: Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.
|
Home and Phone Visit
n=18 Participants
No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.
|
|---|---|---|
|
Physical Activity Step Counts
Baseline
|
1305 average steps per day
Interval 726.0 to 1883.0
|
1369 average steps per day
Interval 724.0 to 2014.0
|
|
Physical Activity Step Counts
12-Week
|
2439 average steps per day
Interval 1844.0 to 3035.0
|
1512 average steps per day
Interval 849.0 to 2175.0
|
|
Physical Activity Step Counts
24-Week
|
2294 average steps per day
Interval 1716.0 to 2873.0
|
1510 average steps per day
Interval 840.0 to 2180.0
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, and 24 weeksPopulation: 38 (35 men, 3 women; 19 INT, 19 CTL) enrolled. 1 INT and 1 CTL lost to follow-up. 36 participants assessed at all time points. Two CTL at 12 weeks and 2 CTL,1 INT at 24 weeks completed questionnaires only.
Scale range is 1-10. The score for the scale is the mean of the six items, using a ten point scale. Higher number indicates higher self-efficacy.
Outcome measures
| Measure |
Exercise, Activity, and Self-management
n=18 Participants
Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.
Exercise: Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.
Walking Program: A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.
Health Self-Management Support: Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.
|
Home and Phone Visit
n=18 Participants
No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.
|
|---|---|---|
|
Self-Efficacy in Managing Chronic Disease Questionnaire
Baseline
|
7.6 units on a scale
Interval 7.1 to 8.3
|
7.5 units on a scale
Interval 6.8 to 8.2
|
|
Self-Efficacy in Managing Chronic Disease Questionnaire
12-Week
|
7.8 units on a scale
Interval 7.2 to 8.4
|
7.9 units on a scale
Interval 7.2 to 8.6
|
|
Self-Efficacy in Managing Chronic Disease Questionnaire
24-Week
|
8.1 units on a scale
Interval 7.5 to 8.7
|
7.5 units on a scale
Interval 6.8 to 8.2
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, and 24 weeksPopulation: 38 (35 men, 3 women; 19 INT, 19 CTL) enrolled. 1 INT and 1 CTL lost to follow-up. 36 participants assessed at all time points. Two CTL at 12 weeks and 2 CTL,1 INT at 24 weeks completed questionnaires only.
Scores ranging from 1 (no difficulty) to 5 (extreme difficulty/cannot do). Overall disability was calculated by summing the scores for the 12 items; higher scores indicated greater disability (score range: 12-60).
Outcome measures
| Measure |
Exercise, Activity, and Self-management
n=18 Participants
Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.
Exercise: Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.
Walking Program: A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.
Health Self-Management Support: Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.
|
Home and Phone Visit
n=18 Participants
No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.
|
|---|---|---|
|
World Health Organization Disability Assessment Scale
Baseline
|
26.2 units on a scale
Interval 22.9 to 29.6
|
27.5 units on a scale
Interval 23.7 to 31.3
|
|
World Health Organization Disability Assessment Scale
12-Week
|
24.2 units on a scale
Interval 20.9 to 27.6
|
25.3 units on a scale
Interval 21.5 to 29.2
|
|
World Health Organization Disability Assessment Scale
24-Week
|
21.6 units on a scale
Interval 18.2 to 25.0
|
25.3 units on a scale
Interval 21.4 to 29.1
|
Adverse Events
Exercise, Activity, and Self-management
Serious events: 4 serious events
Other events: 14 other events
Deaths: 0 deaths
Home and Phone Visit
Serious events: 9 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exercise, Activity, and Self-management
n=19 participants at risk
Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.
Exercise: Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.
Walking Program: A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.
Health Self-Management Support: Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.
|
Home and Phone Visit
n=19 participants at risk
No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.
|
|---|---|---|
|
Cardiac disorders
Hospitalization
|
0.00%
0/19 • 24 weeks
|
5.3%
1/19 • Number of events 1 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization
|
10.5%
2/19 • Number of events 3 • 24 weeks
|
5.3%
1/19 • Number of events 1 • 24 weeks
|
|
Infections and infestations
Hospitalization
|
5.3%
1/19 • Number of events 1 • 24 weeks
|
26.3%
5/19 • Number of events 7 • 24 weeks
|
|
Endocrine disorders
Hospitalization
|
5.3%
1/19 • Number of events 2 • 24 weeks
|
5.3%
1/19 • Number of events 1 • 24 weeks
|
|
Psychiatric disorders
Hospitalization
|
0.00%
0/19 • 24 weeks
|
5.3%
1/19 • Number of events 1 • 24 weeks
|
|
General disorders
Hospitalization
|
0.00%
0/19 • 24 weeks
|
5.3%
1/19 • Number of events 1 • 24 weeks
|
Other adverse events
| Measure |
Exercise, Activity, and Self-management
n=19 participants at risk
Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.
Exercise: Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.
Walking Program: A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.
Health Self-Management Support: Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.
|
Home and Phone Visit
n=19 participants at risk
No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.
|
|---|---|---|
|
General disorders
Fall
|
52.6%
10/19 • Number of events 16 • 24 weeks
|
42.1%
8/19 • Number of events 12 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Wound Infection
|
10.5%
2/19 • Number of events 2 • 24 weeks
|
10.5%
2/19 • Number of events 2 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Blister
|
10.5%
2/19 • Number of events 2 • 24 weeks
|
10.5%
2/19 • Number of events 2 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Foot Ulcer
|
5.3%
1/19 • Number of events 1 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/19 • 24 weeks
|
5.3%
1/19 • Number of events 1 • 24 weeks
|
Additional Information
Dr. Cory Christiansen
University of Colorado Denver, Anschutz Medical Campus
Phone: 303.724.9101
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place