Clinical trial NCT05412550: Walking Exercise Sustainability Through Telehealth for Veterans With Lower-limb Amputation
Official title: Walking Exercise Sustainability Through Telehealth for Veterans With Lower-Limb Amputation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lower-Limb Amputation
Keywords: Transmetatarsal Amputation
Partial Foot Amputation
Transtibial Amputation
Knee Disarticulation
Transfemoral Amputation
Hip Disarticulation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-06-09
Enrollment: 78
Sex: ALL
Minimum age (years): 40
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Veterans living with lower-limb amputation have poor physical health outcomes, multiple chronic comorbidities, high medical service utilization, and high levels of disability. Self-reported disability for people living with lower limb amputation is greater than 95% of the general population. One way to reduce disability for Veterans with lower-limb amputation is for them to participate in life-long sustained walking exercise. Regular exercise improves functional independence and mental well-being, and reduces adverse effects of common comorbidities associated with lower-limb amputation, such as diabetes and peripheral artery disease. However, most Veterans with lower-limb amputation do not regularly exercise. Only 50% of people with lower limb amputation achieve levels of walking activity that support participation in their local community, creating a critical need to improve physical exercise participation after lower-limb amputation. Evidence suggests that clinician-supported exercise in a person's home living environment that includes evidence-based promotion of patient self-management has promise for interrupting the cycle of elevated sedentary behavior and poor health outcomes. Therefore, the primary aim of this randomized controlled superiority trial is to determine if a telerehabilitation walking exercise self-management program produces clinically meaningful walking exercise sustainability compared to attention-control education. This novel, low-cost intervention includes a novel combination of piloted behavior-change methods and clinical resources, including VA multidisciplinary telehealth sessions, individual exercise self-management training, and VA peer-group sessions. In addition, the intervention is integrated within an established VA Regional Amputation Center, using established VA clinical telerehabilitation and technology. Exercise and physical activity will be monitored as a continuous daily outcome, with secondary outcomes assessed at a baseline test and then after 6 and 18 months of intervention participation. The primary outcome will be accelerometer-assessed daily walking step count monitored continuously each day across the 18-month study period. Secondary outcomes are designed to assess the potential to assess how to best translate the walking exercise intervention into conventional VA amputation rehabilitation. These secondary outcomes include measures of intervention reach, intervention efficacy, likelihood of clinical adoption, potential for clinical implementation, and ability of participants to maintain long-term exercise behavior. The unique rehabilitation paradigm used in this study addresses the problem of chronic sedentary lifestyles following lower-limb amputation with a home-based exercise model of life-long exercise support from clinicians and peers. The trial results will advance rehabilitation knowledge and provide the necessary evidence for larger clinical translation of self-management intervention to sustain walking exercise for Veterans living with lower-limb amputation.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Average Daily Step Count
timeFrame: Through study completion: Baseline to 18 months
Secondary outcomes:
measure: Self-Efficacy for Exercise Scale
timeFrame: Through study completion: Baseline to 18 months
measure: 2-Minute Step Test
timeFrame: Through study completion: Baseline to 18 months
measure: Comprehensive Lower Limb Amputee Socket Survey (CLASS)
timeFrame: Through study completion: Baseline to 18 months
measure: Prosthetic Limb Users Survey of Mobility Computer Adaptive Test (PLUS-M CAT)
timeFrame: Through study completion: Baseline to 18 months
measure: 30-Second Chair Rise Test
timeFrame: Through study completion: Baseline to 18 months
measure: Patient-Reported Measurement Information System - Ability to Participate in Social Roles and Activities - Short Form 8A
timeFrame: Through study completion: Baseline to 18 months
measure: World Health Organization Disability Assessment Scale 2.0
timeFrame: Through study completion: Baseline to 18 months
Other outcomes:
measure: Instrumented 2-Minute Step Test with Inertial Measurement Unit Data
timeFrame: Single time point measured in subset of participants at 6 months
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center, Aurora, CO
state: Colorado
Study officials:
affiliation: Rocky Mountain Regional VA Medical Center, Aurora, CO
name: Cory L. Christiansen, PhD
role: PRINCIPAL_INVESTIGATOR
References: