Collaborative-care Rehabilitation After Dysvascular Amputation

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Colorado, Denver
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01929018
First received: August 19, 2013
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Diabetes Complications
Peripheral Arterial Disease
Behavioral: Exercise
Behavioral: Walking Program
Behavioral: Health Self-Management Support

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Collaborative-care Rehabilitation to Improve Functional Outcomes After Dysvascular Amputation

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Change from Baseline in Timed Up-and-Go Test at 12 weeks [ Time Frame: 12-weeks ] [ Designated as safety issue: No ]
    Performance-based physical function test


Secondary Outcome Measures:
  • Change from Baseline in the Two-Minute Walk Test at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Performance-based physical function test

  • Change from Baseline in Five Meter Walk Test at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Performance-based physical function test

  • Prosthesis Evaluation Questionnaire - Mobility Section [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Self-report physical function questionnaire

  • Houghton Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Self-report physical function questionnaire

  • Patient-Specific Function Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Self-report physical function questionnaire

  • Change from Baseline in Physical Activity Counts at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Instrumented physical activity measure

  • Self-Efficacy in Managing Chronic Disease Questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Self-report questionnaire

  • World Health Organization Disability Assessment Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Self-report disability questionnaire


Estimated Enrollment: 44
Study Start Date: September 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diabetes and/or Peripheral Artery Disease
  2. Unilateral transtibial amputation < 6 months prior to screening
  3. Household ambulation (or better) using prosthesis prior to screening
  4. Participation in physical rehabilitation for prosthetic-use training
  5. Within the age range of 50 to 85 years old

Exclusion Criteria:

  1. Goal of wheelchair use as a primary form of locomotion (use prosthesis for transfers only)
  2. Ankle-level or more proximal amputation on contralateral limb
  3. Traumatic or cancer-related lower limb amputation
  4. Unstable heart condition (incl. unstable angina, uncontrolled cardiac dysrhythmia, acute myocarditis, and acute pericarditis)
  5. Uncontrolled hypertension
  6. Acute systemic infection
  7. Pregnant women
  8. Decisionally challenged volunteers
  9. Prisoners
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01929018

Contacts
Contact: Cory L Christiansen, PT, PhD 303 724-9101 cory.christiansen@ucdenver.edu

Locations
United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Cory L Christiansen, PT, PhD    303-724-9101    cory.christiansen@ucdenver.edu   
Principal Investigator: Cory L Christiansen, PT, PhD         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Cory L Christiansen, PT, PhD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01929018     History of Changes
Other Study ID Numbers: 13-0179
Study First Received: August 19, 2013
Last Updated: October 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Amputation
Rehabilitation
Exercise
Movement

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Diabetes Complications
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 30, 2014