Collaborative-care Rehabilitation After Dysvascular Amputation

Collaborative-care Rehabilitation to Improve Functional Outcomes After Dysvascular Amputation

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Complications; Peripheral Arterial Disease
• Intervention / Treatment: Behavioral: Exercise; Behavioral: Walking Program; Behavioral: Health Self-Management Support

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Exercise; Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.; Behavioral: 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.; Behavioral: Health Self-Management Support; Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2013
• Primary Completion (Actual): March 27, 2017
• Study Completion (Actual): June 29, 2017

Study Registration Dates

• First Submitted: August 19, 2013
• First Submitted That Met QC Criteria: August 21, 2013
• First Posted (Estimate): August 27, 2013

Study Record Updates

• Last Update Posted (Actual): August 14, 2019
• Last Update Submitted That Met QC Criteria: July 18, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Rehabilitation; Exercise; Movement; Amputation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Endocrine System Diseases; Diabetes Mellitus; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Diabetes Complications
• Other Study ID Numbers: 13-0179