Walking Exercise Sustainability Through Telehealth for Veterans With Lower-limb Amputation

NCT05412550 | Active Not Recruiting DMC

• 1 other identifier: A3917-R
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lower-Limb Amputation

Keywords

Transmetatarsal Amputation; Partial Foot Amputation; Transtibial Amputation; Knee Disarticulation; Transfemoral Amputation; Hip Disarticulation

Outcome Measures

Primary Outcomes (1)

• Average Daily Step Count

  Average daily step count will be measured and recorded continuously for the 18-month study period, using a waist-mounted tri-axial accelerometer.

  Through study completion: Baseline to 18 months

Secondary Outcomes (7)

• Self-Efficacy for Exercise Scale

  Through study completion: Baseline to 18 months

• 2-Minute Step Test

  Through study completion: Baseline to 18 months

• Comprehensive Lower Limb Amputee Socket Survey (CLASS)

  Through study completion: Baseline to 18 months

• Prosthetic Limb Users Survey of Mobility Computer Adaptive Test (PLUS-M CAT)

  Through study completion: Baseline to 18 months

• 30-Second Chair Rise Test

  Through study completion: Baseline to 18 months

Other Outcomes (1)

• Instrumented 2-Minute Step Test with Inertial Measurement Unit Data

  Single time point measured in subset of participants at 6 months

Study Arms (2)

Exercise self-management

EXPERIMENTAL

The EXP intervention will integrate conventional telehealth care with exercise self-management training and include structured 1:1 sessions (six) with an interventionist, peer group sessions (six), real-time step count feedback throughout the 18 months using a wrist-worn Fitbit with an LED interface, and tailored messaging with text messages designed using six key behavior-change techniques promoting exercise self-management.

Behavioral: Exercise self-management

Attention control

ACTIVE COMPARATOR

The CTL intervention will incorporate the annual multidisciplinary team telehealth sessions, 12 attention-control telehealth sessions (six individual, six peer-group), and general health education text message prompts to match the timing and duration of the EXP group.

Behavioral: Attention control

Interventions

Exercise self-management BEHAVIORAL

Six walking exercise self-management telehealth sessions will focus on behavior change techniques and personalized action plans. Peer support groups will be held every three months, and will be focused on supporting participants in attaining sustained exercise. Text message prompts will focus on encouraging exercise and health self-management.

Also known as: EXP

Exercise self-management

Attention control BEHAVIORAL

The six individual telehealth sessions, six peer-group sessions, and text message prompts will focus on general health education. No prompts for exercise or health self-management will be given.

Also known as: CTL

Attention control

Eligibility Criteria

• Age: 40 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral or bilateral lower-limb amputation (transmetatarsal to him disarticulation, traumatic or non-traumatic etiology)
• Ability to walk two minutes without seated rest using prosthesis and assistive device if needed
• Living without assistance for basic activities of daily living

You may not qualify if:

• Congenital or cancer-related amputation
• Unstable heart condition including:
• unstable angina
• uncontrolled cardiac dysrhythmia
• acute myocarditis
• acute pericarditis
• Acute systemic infection
• Prisoner
• Mild cognitive impairment
• Active cancer treatment
• Discretion of PI to exclude patients who are determined to be unsafe and/or inappropriate to participate

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

Location

Study Officials

• Cory L. Christiansen, PhD

  Rocky Mountain Regional VA Medical Center, Aurora, CO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The PI and Outcomes Assessors will be blinded to participant group allocation. The participant and interventionist will not be blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Two-arm randomized controlled trial

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: June 9, 2022
• Study Start: November 1, 2022
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)