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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise, activity, and self-management | Experimental | 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. |
|
| Home and phone visit | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 12-weeks, and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Two-Minute Walk Test | Performance-based physical function test measures total number of meters walked in two minutes on a level walkway. | Baseline, 12 weeks, and 24 weeks |
| Five Meter Walk Test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cory L Christiansen, PT, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29746823 | Derived | Christiansen CL, Miller MJ, Murray AM, Stephenson RO, Stevens-Lapsley JE, Hiatt WR, Schenkman ML. Behavior-Change Intervention Targeting Physical Function, Walking, and Disability After Dysvascular Amputation: A Randomized Controlled Pilot Trial. Arch Phys Med Rehabil. 2018 Nov;99(11):2160-2167. doi: 10.1016/j.apmr.2018.04.011. Epub 2018 May 7. |
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No significant study events occurred after participants were enrolled, but before they were assigned to a study group.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | seconds | Baseline, 12-weeks, and 24 weeks |
|
24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | General disorders | Non-systematic Assessment |
Small sample size limited statistical power to identify group differences in secondary outcomes. CTL group exercise behavior only tracked step count. No direct measurement of intervention fidelity.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cory Christiansen | University of Colorado Denver, Anschutz Medical Campus | 303.724.9101 | cory.christiansen@ucdenver.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 5, 2014 | Oct 26, 2017 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 5, 2014 | Oct 26, 2017 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D048909 | Diabetes Complications |
| D058729 | Peripheral Arterial Disease |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Walking Program | Behavioral | 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 | Behavioral | Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period. |
|
Performance-based physical function test measures the time to walk 5 meters at the participant's "normal, everyday pace".
| Baseline, 12 weeks, and 24 weeks |
| 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. | Baseline, 12 weeks, and 24 weeks |
| 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. | Baseline, 12 weeks, and 24 weeks |
| 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. | Baseline, 12 weeks, and 24 weeks |
| Physical Activity Step Counts | Instrumented physical activity measure, average step counts per day | Baseline, 12 weeks, and 24 weeks |
| 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. | Baseline, 12 weeks, and 24 weeks |
| 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). | Baseline, 12 weeks, and 24 weeks |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Site of Rehab, n, Veterans Administration Medical Center | Number of participants treated at Veterans Administration Medical Center | Count of Participants | Participants |
|
| BMI, kg/m2 | Mean | Standard Deviation | kg/m^2 |
|
| Time Since Amputation, weeks | Mean | Standard Deviation | weeks |
|
| Geriatric Depression Scale, score out of 15 | Scale range is 0-15. Score is total out of possible maximum of 15. A score of 0 to 5 is normal. A score greater than 5 suggests referral for assessment of depression. | Mean | Standard Deviation | units on a scale |
|
| Mini Mental Status Exam, score out of 30 | The maximum score is 30 points. Score of 20 to 24 suggests mild dementia, 13 to 20 suggests moderate dementia, and less than 12 indicates severe dementia. | Mean | Standard Deviation | units on a scale |
|
| Intrinsic Motivation Inventory, score out of 7 | The mean of the 7 items is the summary score for the Intrinsic Motivation - Interest and Enjoyment Subscale (Min possible 1, Max possible 7). Higher number indicates higher interest/enjoyment. | Mean | Standard Deviation | units on a scale |
|
| Chakrabarty Grade, score out of 100 | The sum of all items is the score (Min possible -104, Max possible 100). Higher score indicates more favorable residual limb health. | Mean | Standard Deviation | units on a scale |
|
| Comorbidity Index, score out of 20 | The comorbidity index is a sum of 18 comorbidities (Min possible 0, Max possible 18). Higher score indicates higher comorbidity. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. |
|
|
|
| Secondary | Two-Minute Walk Test | Performance-based physical function test measures total number of meters walked in two minutes on a level walkway. | 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. | Posted | Mean | 95% Confidence Interval | meters | Baseline, 12 weeks, and 24 weeks |
|
|
|
|
| Secondary | Five Meter Walk Test | Performance-based physical function test measures the time to walk 5 meters at the participant's "normal, everyday pace". | 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. | Posted | Mean | 95% Confidence Interval | meters/second | Baseline, 12 weeks, and 24 weeks |
|
|
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 12 weeks, and 24 weeks |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 12 weeks, and 24 weeks |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 12 weeks, and 24 weeks |
|
|
|
|
| Secondary | Physical Activity Step Counts | Instrumented physical activity measure, average step counts per day | 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. | Posted | Mean | 95% Confidence Interval | average steps per day | Baseline, 12 weeks, and 24 weeks |
|
|
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 12 weeks, and 24 weeks |
|
|
|
|
| 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). | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 12 weeks, and 24 weeks |
|
|
|
|
| 0 |
| 19 |
| 4 |
| 19 |
| 14 |
| 19 |
| EG001 | 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. | 0 | 19 | 9 | 19 | 11 | 19 |
| Hospitalization | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Pneumonia |
|
| Hospitalization | Infections and infestations | Non-systematic Assessment |
|
| Hospitalization | Endocrine disorders | Non-systematic Assessment | Hypoglycemia |
|
| Hospitalization | Psychiatric disorders | Non-systematic Assessment | Hallucinations |
|
| Hospitalization | General disorders | Non-systematic Assessment | Opiod Overdose |
|
| Hospitalization | General disorders | Non-systematic Assessment | Edema |
|
| Hospitalization | General disorders | Non-systematic Assessment | Increased medical management |
|
| Wound Infection | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Foot Ulcer | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | Non-systematic Assessment |
|
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| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D001519 | Behavior |
| 12-Week |
|
|
| 24-Week |
|
|
| Mixed Models Analysis |
| 0.11 |
| Superiority |
| 12-Week |
|
|
| 24-Week |
|
|
| Mixed Models Analysis |
| 0.23 |
| Superiority |
| 24-Week |
|
| Mixed Models Analysis |
| 0.58 |
| Superiority |
| 24-Week |
|
| Mixed Models Analysis |
| 0.13 |
| Superiority |
| 24 weeks |
|
| t-test, 2 sided |
| 0.02 |
| Superiority |
| 12-Week |
|
|
| 24-Week |
|
|
| Mixed Models Analysis |
| 0.06 |
| Superiority |
| 24-Week |
|
| Mixed Models Analysis |
| 0.40 |
| Superiority |
| 24-Week |
|
| Mixed Models Analysis |
| 0.35 |
| Superiority |