Diabetes Complications, Peripheral Arterial Disease
Conditions
Keywords
Amputation, Rehabilitation, Exercise, Movement
Brief summary
The objective of this study is to examine the feasibility of using a collaborative-care, home-based rehabilitation program to improve functional outcomes for people recovering from lower limb amputation caused by vascular problems and/or diabetes complications. The primary hypothesis is that the rehabilitation program will result in greater improvements in performance-based and participant-reported measures of physical function, compared to standard of care after outpatient rehabilitation.
Interventions
BEHAVIORALExercise
Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.
BEHAVIORALWalking 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.
BEHAVIORALHealth Self-Management Support
Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Diabetes and/or Peripheral Artery Disease 2. Unilateral transtibial amputation \< 6 months prior to screening 3. Household ambulation using definitive prosthesis prior to baseline testing 4. Participation in physical rehabilitation at time of baseline testing 5. Live within 45 minutes of a participating clinic
Exclusion criteria
1. Require wheelchair for mobility (use prosthesis for transfers only) 2. Ankle-level or above amputation on contralateral limb 3. Traumatic or cancer-related amputation 4. Uncontrolled heart condition 5. Acute systemic infection 6. Pregnancy 7. Decisionally challenged 8. Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timed Up-and-Go Test | Baseline, 12-weeks, and 24 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Five Meter Walk Test | Baseline, 12 weeks, and 24 weeks | Performance-based physical function test measures the time to walk 5 meters at the participant's normal, everyday pace. |
| Prosthesis Evaluation Questionnaire - Mobility Section | Baseline, 12 weeks, and 24 weeks | 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. |
| Houghton Scale | Baseline, 12 weeks, and 24 weeks | 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. |
| Two-Minute Walk Test | Baseline, 12 weeks, and 24 weeks | Performance-based physical function test measures total number of meters walked in two minutes on a level walkway. |
| Physical Activity Step Counts | Baseline, 12 weeks, and 24 weeks | Instrumented physical activity measure, average step counts per day |
| Self-Efficacy in Managing Chronic Disease Questionnaire | Baseline, 12 weeks, and 24 weeks | 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. |
| World Health Organization Disability Assessment Scale | Baseline, 12 weeks, and 24 weeks | 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). |
| Patient-Specific Function Scale | Baseline, 12 weeks, and 24 weeks | 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. |
Countries
United States
Participant flow
Pre-assignment details
No significant study events occurred after participants were enrolled, but before they were assigned to a study group.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 19 |
| 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. | 19 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Hospitalization | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Exercise, Activity, and Self-management | Home and Phone Visit | Total |
|---|---|---|---|
| Age, Continuous | 62 Years STANDARD_DEVIATION 6 | 65 Years STANDARD_DEVIATION 11.3 | 63.6 Years STANDARD_DEVIATION 9.1 |
| BMI, kg/m2 | 31 kg/m^2 STANDARD_DEVIATION 10.6 | 30 kg/m^2 STANDARD_DEVIATION 6.3 | 31 kg/m^2 STANDARD_DEVIATION 8.6 |
| Chakrabarty Grade, score out of 100 | 77.3 units on a scale STANDARD_DEVIATION 16.2 | 82.4 units on a scale STANDARD_DEVIATION 15 | 79.8 units on a scale STANDARD_DEVIATION 15.6 |
| Comorbidity Index, score out of 20 | 6.1 units on a scale STANDARD_DEVIATION 2.7 | 7.1 units on a scale STANDARD_DEVIATION 2.3 | 6.6 units on a scale STANDARD_DEVIATION 2.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 16 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Geriatric Depression Scale, score out of 15 | 2.8 units on a scale STANDARD_DEVIATION 3.2 | 3.2 units on a scale STANDARD_DEVIATION 2.6 | 3.0 units on a scale STANDARD_DEVIATION 2.9 |
| Intrinsic Motivation Inventory, score out of 7 | 5.6 units on a scale STANDARD_DEVIATION 1 | 5.6 units on a scale STANDARD_DEVIATION 1.1 | 5.6 units on a scale STANDARD_DEVIATION 1.1 |
| Mini Mental Status Exam, score out of 30 | 28.6 units on a scale STANDARD_DEVIATION 1.2 | 27.5 units on a scale STANDARD_DEVIATION 2.5 | 28.2 units on a scale STANDARD_DEVIATION 2.1 |
| Region of Enrollment United States | 19 Participants | 19 Participants | 38 Participants |
| Sex: Female, Male Female | 3 Participants | 0 Participants | 3 Participants |
| Sex: Female, Male Male | 16 Participants | 19 Participants | 35 Participants |
| Site of Rehab, n, Veterans Administration Medical Center | 10 Participants | 10 Participants | 20 Participants |
| Time Since Amputation, weeks | 16 weeks STANDARD_DEVIATION 6.5 | 20 weeks STANDARD_DEVIATION 6.4 | 18 weeks STANDARD_DEVIATION 6.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 14 / 19 | 11 / 19 |
| serious Total, serious adverse events | 4 / 19 | 9 / 19 |
Outcome results
Primary
Timed Up-and-Go Test
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.
Time frame: Baseline, 12-weeks, and 24 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Exercise, Activity, and Self-management | Timed Up-and-Go Test | Baseline | 19.4 seconds |
| Exercise, Activity, and Self-management | Timed Up-and-Go Test | 12-Week | 18.2 seconds |
| Exercise, Activity, and Self-management | Timed Up-and-Go Test | 24-week | 16.7 seconds |
| Home and Phone Visit | Timed Up-and-Go Test | Baseline | 20.7 seconds |
| Home and Phone Visit | Timed Up-and-Go Test | 12-Week | 18.8 seconds |
| Home and Phone Visit | Timed Up-and-Go Test | 24-week | 21.3 seconds |
Comparison: Test null hypothesis that there is no difference between groups from baseline to 12-week test.p-value: 0.87Mixed Models Analysis
Comparison: Test null hypothesis that there is no difference between groups from baseline to 24-week test.p-value: 0.38Mixed Models Analysis
Secondary
Five Meter Walk Test
Performance-based physical function test measures the time to walk 5 meters at the participant's normal, everyday pace.
Time frame: Baseline, 12 weeks, and 24 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Exercise, Activity, and Self-management | Five Meter Walk Test | 24-Week | 0.97 meters/second |
| Exercise, Activity, and Self-management | Five Meter Walk Test | Baseline | 0.78 meters/second |
| Exercise, Activity, and Self-management | Five Meter Walk Test | 12-Week | 0.96 meters/second |
| Home and Phone Visit | Five Meter Walk Test | Baseline | 0.76 meters/second |
| Home and Phone Visit | Five Meter Walk Test | 12-Week | 0.83 meters/second |
| Home and Phone Visit | Five Meter Walk Test | 24-Week | 0.86 meters/second |
Comparison: Test null hypothesis that there is no difference between groups from baseline to 12-week test.p-value: 0.11Mixed Models Analysis
Comparison: Test null hypothesis that there is no difference between groups from baseline to 24-week test.p-value: 0.23Mixed Models Analysis
Secondary
Houghton Scale
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.
Time frame: Baseline, 12 weeks, and 24 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise, Activity, and Self-management | Houghton Scale | Baseline | 0.64 units on a scale | Standard Deviation 0.15 |
| Exercise, Activity, and Self-management | Houghton Scale | 12-Week | 0.69 units on a scale | Standard Deviation 0.28 |
| Exercise, Activity, and Self-management | Houghton Scale | 24-Week | 0.77 units on a scale | Standard Deviation 0.18 |
| Home and Phone Visit | Houghton Scale | Baseline | 0.62 units on a scale | Standard Deviation 0.23 |
| Home and Phone Visit | Houghton Scale | 12-Week | 0.69 units on a scale | Standard Deviation 0.24 |
| Home and Phone Visit | Houghton Scale | 24-Week | 0.65 units on a scale | Standard Deviation 0.27 |
Comparison: Test null hypothesis that there is no difference between groups from baseline to 12-week test.p-value: 0.83Mixed Models Analysis
Comparison: Test null hypothesis that there is no difference between groups from baseline to 24-week test.p-value: 0.13Mixed Models Analysis
Secondary
Patient-Specific Function Scale
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.
Time frame: Baseline, 12 weeks, and 24 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise, Activity, and Self-management | Patient-Specific Function Scale | Baseline | 3.3 units on a scale | Standard Deviation 1.8 |
| Exercise, Activity, and Self-management | Patient-Specific Function Scale | 12 weeks | 5.7 units on a scale | Standard Deviation 2.6 |
| Exercise, Activity, and Self-management | Patient-Specific Function Scale | 24 weeks | 6.9 units on a scale | Standard Deviation 2.3 |
| Home and Phone Visit | Patient-Specific Function Scale | Baseline | 3.5 units on a scale | Standard Deviation 1.9 |
| Home and Phone Visit | Patient-Specific Function Scale | 12 weeks | 5.1 units on a scale | Standard Deviation 2.3 |
| Home and Phone Visit | Patient-Specific Function Scale | 24 weeks | 5.3 units on a scale | Standard Deviation 2.3 |
Comparison: Test null hypothesis that there is no difference between groups from baseline to 12-week test.p-value: 0.03t-test, 2 sided
Comparison: Test null hypothesis that there is no difference between groups from baseline to 24-week test.p-value: 0.02t-test, 2 sided
Secondary
Physical Activity Step Counts
Instrumented physical activity measure, average step counts per day
Time frame: Baseline, 12 weeks, and 24 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Exercise, Activity, and Self-management | Physical Activity Step Counts | Baseline | 1305 average steps per day |
| Exercise, Activity, and Self-management | Physical Activity Step Counts | 12-Week | 2439 average steps per day |
| Exercise, Activity, and Self-management | Physical Activity Step Counts | 24-Week | 2294 average steps per day |
| Home and Phone Visit | Physical Activity Step Counts | Baseline | 1369 average steps per day |
| Home and Phone Visit | Physical Activity Step Counts | 12-Week | 1512 average steps per day |
| Home and Phone Visit | Physical Activity Step Counts | 24-Week | 1510 average steps per day |
Comparison: Test null hypothesis that there is no difference between groups from baseline to 12-week test.p-value: 0.03Mixed Models Analysis
Comparison: Test null hypothesis that there is no difference between groups from baseline to 24-week test.p-value: 0.06Mixed Models Analysis
Secondary
Prosthesis Evaluation Questionnaire - Mobility Section
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.
Time frame: Baseline, 12 weeks, and 24 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Exercise, Activity, and Self-management | Prosthesis Evaluation Questionnaire - Mobility Section | Baseline | 2.2 units on a scale |
| Exercise, Activity, and Self-management | Prosthesis Evaluation Questionnaire - Mobility Section | 12-Week | 2.6 units on a scale |
| Exercise, Activity, and Self-management | Prosthesis Evaluation Questionnaire - Mobility Section | 24-Week | 2.7 units on a scale |
| Home and Phone Visit | Prosthesis Evaluation Questionnaire - Mobility Section | Baseline | 2.1 units on a scale |
| Home and Phone Visit | Prosthesis Evaluation Questionnaire - Mobility Section | 12-Week | 2.0 units on a scale |
| Home and Phone Visit | Prosthesis Evaluation Questionnaire - Mobility Section | 24-Week | 2.4 units on a scale |
Comparison: Test null hypothesis that there is no difference between groups from baseline to 12-week test.p-value: 0.27Mixed Models Analysis
Comparison: Test null hypothesis that there is no difference between groups from baseline to 24-week test.p-value: 0.58Mixed Models Analysis
Secondary
Self-Efficacy in Managing Chronic Disease Questionnaire
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.
Time frame: Baseline, 12 weeks, and 24 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Exercise, Activity, and Self-management | Self-Efficacy in Managing Chronic Disease Questionnaire | Baseline | 7.6 units on a scale |
| Exercise, Activity, and Self-management | Self-Efficacy in Managing Chronic Disease Questionnaire | 12-Week | 7.8 units on a scale |
| Exercise, Activity, and Self-management | Self-Efficacy in Managing Chronic Disease Questionnaire | 24-Week | 8.1 units on a scale |
| Home and Phone Visit | Self-Efficacy in Managing Chronic Disease Questionnaire | Baseline | 7.5 units on a scale |
| Home and Phone Visit | Self-Efficacy in Managing Chronic Disease Questionnaire | 12-Week | 7.9 units on a scale |
| Home and Phone Visit | Self-Efficacy in Managing Chronic Disease Questionnaire | 24-Week | 7.5 units on a scale |
Comparison: Test null hypothesis that there is no difference between groups from baseline to 12-week test.p-value: 0.62Mixed Models Analysis
Comparison: Test null hypothesis that there is no difference between groups from baseline to 24-week test.p-value: 0.4Mixed Models Analysis
Secondary
Two-Minute Walk Test
Performance-based physical function test measures total number of meters walked in two minutes on a level walkway.
Time frame: Baseline, 12 weeks, and 24 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Exercise, Activity, and Self-management | Two-Minute Walk Test | Baseline | 86.9 meters |
| Exercise, Activity, and Self-management | Two-Minute Walk Test | 12-Week | 88.5 meters |
| Exercise, Activity, and Self-management | Two-Minute Walk Test | 24-Week | 99.8 meters |
| Home and Phone Visit | Two-Minute Walk Test | Baseline | 84.4 meters |
| Home and Phone Visit | Two-Minute Walk Test | 12-Week | 83.3 meters |
| Home and Phone Visit | Two-Minute Walk Test | 24-Week | 84.0 meters |
Comparison: Test null hypothesis that there is no difference between groups from baseline to 12-week test.p-value: 0.75Mixed Models Analysis
Comparison: Test null hypothesis that there is no difference between groups from baseline to 24-week test.p-value: 0.11Mixed Models Analysis
Secondary
World Health Organization Disability Assessment Scale
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).
Time frame: Baseline, 12 weeks, and 24 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Exercise, Activity, and Self-management | World Health Organization Disability Assessment Scale | Baseline | 26.2 units on a scale |
| Exercise, Activity, and Self-management | World Health Organization Disability Assessment Scale | 12-Week | 24.2 units on a scale |
| Exercise, Activity, and Self-management | World Health Organization Disability Assessment Scale | 24-Week | 21.6 units on a scale |
| Home and Phone Visit | World Health Organization Disability Assessment Scale | Baseline | 27.5 units on a scale |
| Home and Phone Visit | World Health Organization Disability Assessment Scale | 12-Week | 25.3 units on a scale |
| Home and Phone Visit | World Health Organization Disability Assessment Scale | 24-Week | 25.3 units on a scale |
Comparison: Test null hypothesis that there is no difference between groups from baseline to 12-week test.p-value: 0.96Mixed Models Analysis
Comparison: Test null hypothesis that there is no difference between groups from baseline to 24-week test.p-value: 0.35Mixed Models Analysis