Exercise self-management for Lower-Limb Amputation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Rocky Mountain Regional VA Medical Center, Aurora, CO, Aurora, CO
Lower-Limb Amputation
Exercise self-management - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

Despite recent advances in physical rehabilitation, Veterans with lower-limb amputation have poor long-term outcomes, including severely limited functional capacity and high levels of disability. Such poor outcomes are compounded by a lack of exercise participation over time, even with use of lower-limb prostheses. There is a clear need to advance current rehabilitation strategies to better promote sustained exercise following lower-limb amputation. To address this need, the study will determine the potential of a walking exercise self-management program to achieve sustained exercise participation. The 18-month intervention is focused on helping Veterans reduce habitual sedentary behavior through a remote exercise behavior-change intervention that includes multiple clinical disciplines, individualized exercise self-management training, and peer support. This innovative approach shifts the conventional rehabilitation paradigm to specifically target life-long exercise sustainability and remove an underlying cause of disability for Veterans with lower-limb amputation.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Lower-Limb Amputation

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Through study completion: Baseline to 18 months

Month 6
Instrumented 2-Minute Step Test with Inertial Measurement Unit Data
Month 18
2-Minute Step Test
30-Second Chair Rise Test
Average Daily Step Count
Comprehensive Lower Limb Amputee Socket Survey (CLASS)
Patient-Reported Measurement Information System - Ability to Participate in Social Roles and Activities - Short Form 8A
Prosthetic Limb Users Survey of Mobility Computer Adaptive Test (PLUS-M CAT)
Self-Efficacy for Exercise Scale
World Health Organization Disability Assessment Scale 2.0

Trial Safety

Safety Progress

1 of 3

Other trials for Lower-Limb Amputation

Trial Design

2 Treatment Groups

Attention control
1 of 2
Exercise self-management
1 of 2
Active Control
Experimental Treatment

78 Total Participants · 2 Treatment Groups

Primary Treatment: Exercise self-management · No Placebo Group · N/A

Exercise self-management
Behavioral
Experimental Group · 1 Intervention: Exercise self-management · Intervention Types: Behavioral
Attention control
Behavioral
ActiveComparator Group · 1 Intervention: Attention control · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion: baseline to 18 months
Closest Location: Rocky Mountain Regional VA Medical Center, Aurora, CO · Aurora, CO
Photo of aurora 1Photo of aurora 2Photo of aurora 3
2022First Recorded Clinical Trial
1 TrialsResearching Lower-Limb Amputation
15 CompletedClinical Trials

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,459 Previous Clinical Trials
2,748,835 Total Patients Enrolled
Cory L. Christiansen, PhDPrincipal InvestigatorRocky Mountain Regional VA Medical Center, Aurora, CO
3 Previous Clinical Trials
199 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are able to walk two minutes without seated rest using prosthesis and assistive device if needed.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.