Collaborative-care Rehabilitation After Dysvascular Amputation
Primary Purpose
Diabetes Complications, Peripheral Arterial Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Walking Program
Health Self-Management Support
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Complications focused on measuring Amputation, Rehabilitation, Exercise, Movement
Eligibility Criteria
Inclusion Criteria:
- Diabetes and/or Peripheral Artery Disease
- Unilateral transtibial amputation < 6 months prior to screening
- Household ambulation using definitive prosthesis prior to baseline testing
- Participation in physical rehabilitation at time of baseline testing
- Live within 45 minutes of a participating clinic
Exclusion Criteria:
- Require wheelchair for mobility (use prosthesis for transfers only)
- Ankle-level or above amputation on contralateral limb
- Traumatic or cancer-related amputation
- Uncontrolled heart condition
- Acute systemic infection
- Pregnancy
- Decisionally challenged
- Prisoners
Sites / Locations
- University of Colorado Anschutz Medical Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise, activity, and self-management
Home and phone visit
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Two-Minute Walk Test
Performance-based physical function test measures total number of meters walked in two minutes on a level walkway.
Five Meter Walk Test
Performance-based physical function test measures the time to walk 5 meters at the participant's "normal, everyday pace".
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.
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.
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.
Physical Activity Step Counts
Instrumented physical activity measure, average step counts per day
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.
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).
Full Information
NCT ID
NCT01929018
First Posted
August 19, 2013
Last Updated
July 18, 2019
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT01929018
Brief Title
Collaborative-care Rehabilitation After Dysvascular Amputation
Official Title
Collaborative-care Rehabilitation to Improve Functional Outcomes After Dysvascular Amputation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 9, 2013 (Actual)
Primary Completion Date
March 27, 2017 (Actual)
Study Completion Date
June 29, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Complications, Peripheral Arterial Disease
Keywords
Amputation, Rehabilitation, Exercise, Movement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise, activity, and self-management
Arm Type
Experimental
Arm Description
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.
Arm Title
Home and phone visit
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.
Intervention Type
Behavioral
Intervention Name(s)
Walking Program
Intervention Description
A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Health Self-Management Support
Intervention Description
Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.
Primary Outcome Measure Information:
Title
Timed Up-and-Go Test
Description
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
Secondary Outcome Measure Information:
Title
Two-Minute Walk Test
Description
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
Title
Five Meter Walk Test
Description
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
Title
Prosthesis Evaluation Questionnaire - Mobility Section
Description
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
Title
Houghton Scale
Description
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
Title
Patient-Specific Function Scale
Description
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
Title
Physical Activity Step Counts
Description
Instrumented physical activity measure, average step counts per day
Time Frame
Baseline, 12 weeks, and 24 weeks
Title
Self-Efficacy in Managing Chronic Disease Questionnaire
Description
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
Title
World Health Organization Disability Assessment Scale
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diabetes and/or Peripheral Artery Disease
Unilateral transtibial amputation < 6 months prior to screening
Household ambulation using definitive prosthesis prior to baseline testing
Participation in physical rehabilitation at time of baseline testing
Live within 45 minutes of a participating clinic
Exclusion Criteria:
Require wheelchair for mobility (use prosthesis for transfers only)
Ankle-level or above amputation on contralateral limb
Traumatic or cancer-related amputation
Uncontrolled heart condition
Acute systemic infection
Pregnancy
Decisionally challenged
Prisoners
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cory L Christiansen, PT, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29746823
Citation
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.
Results Reference
derived
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Collaborative-care Rehabilitation After Dysvascular Amputation
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