Collaborative-care Rehabilitation After Dysvascular Amputation

NCT01929018 | Completed Results

• 1 other identifier: 13-0179
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Complications; Peripheral Arterial Disease

Keywords

Amputation; Rehabilitation; Exercise; Movement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Two-Minute Walk Test

  Baseline, 12 weeks, and 24 weeks

• Five Meter Walk Test

  Baseline, 12 weeks, and 24 weeks

• Prosthesis Evaluation Questionnaire - Mobility Section

  Baseline, 12 weeks, and 24 weeks

• Houghton Scale

  Baseline, 12 weeks, and 24 weeks

• Patient-Specific Function Scale

  Baseline, 12 weeks, and 24 weeks

Study Arms (2)

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.

Behavioral: Exercise; Behavioral: Walking Program; Behavioral: Health Self-Management Support

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.

Interventions

Exercise BEHAVIORAL

Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.

Exercise, activity, and self-management

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.

Exercise, activity, and self-management

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.

Exercise, activity, and self-management

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• 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.

  PMID: 29746823 DERIVED

MeSH Terms

Conditions

Diabetes Complications; Peripheral Arterial Disease; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Endocrine System Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Cory Christiansen
• Organization: University of Colorado Denver, Anschutz Medical Campus

cory.christiansen@ucdenver.edu

303.724.9101

Study Officials

• Cory L Christiansen, PT, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2013
• First Posted: August 27, 2013
• Study Start: October 9, 2013
• Primary Completion: March 27, 2017
• Study Completion: June 29, 2017
• Last Updated: August 14, 2019
• Results First Posted: August 14, 2019

Record last verified: 2019-07

Locations

US (1)