Walking Exercise Sustainability Through Telehealth for Veterans With Lower-limb Amputation (WEST)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05412550|
Recruitment Status : Recruiting
First Posted : June 9, 2022
Last Update Posted : December 27, 2022
|Condition or disease||Intervention/treatment||Phase|
|Lower-Limb Amputation||Behavioral: Exercise self-management Behavioral: Attention control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Two-arm randomized controlled trial|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||The PI and Outcomes Assessors will be blinded to participant group allocation. The participant and interventionist will not be blinded.|
|Primary Purpose:||Supportive Care|
|Official Title:||Walking Exercise Sustainability Through Telehealth for Veterans With Lower-Limb Amputation|
|Actual Study Start Date :||November 1, 2022|
|Estimated Primary Completion Date :||October 31, 2026|
|Estimated Study Completion Date :||October 31, 2026|
Experimental: Exercise self-management
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
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.
Other Name: EXP
Active Comparator: Attention control
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
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.
Other Name: CTL
- Average Daily Step Count [ Time Frame: Through study completion: Baseline to 18 months ]Average daily step count will be measured and recorded continuously for the 18-month study period, using a waist-mounted tri-axial accelerometer.
- Self-Efficacy for Exercise Scale [ Time Frame: Through study completion: Baseline to 18 months ]A 9-item questionnaire to measure of exercise self-efficacy. Final scores can range from 0 (not confident in exercise self-efficacy) to 90 (confident in exercise self-efficacy).
- 2-Minute Step Test [ Time Frame: Through study completion: Baseline to 18 months ]Number of steps-in-place a participant completes in two minutes.
- Comprehensive Lower Limb Amputee Socket Survey (CLASS) [ Time Frame: Through study completion: Baseline to 18 months ]A 15-item questionnaire to measure socket satisfaction on 4 subscales: 1) Stability, 2) Suspension, 3) Comfort, and 4) Appearance. Each subscale is reported on a 0% to 100% scale with 100% indicating excellent satisfaction.
- Prosthetic Limb Users Survey of Mobility Computer Adaptive Test (PLUS-M CAT) [ Time Frame: Through study completion: Baseline to 18 months ]A computer adaptive measure of a prosthesis users mobility with 4-12 items. T-scores are reported between 17.5 and 76.6 with higher scores indicating more independent mobility.
- 30-Second Chair Rise Test [ Time Frame: Through study completion: Baseline to 18 months ]Number of full stands completed in 30 seconds.
- Patient-Reported Measurement Information System - Ability to Participate in Social Roles and Activities - Short Form 8A [ Time Frame: Through study completion: Baseline to 18 months ]An 8-item questionnaire which measures social functioning. Scores are reported between 8 and 40 with higher scores indicating higher ability to participate in social roles and activities.
- World Health Organization Disability Assessment Scale 2.0 [ Time Frame: Through study completion: Baseline to 18 months ]Self-reported assessment of disability using a scale from 0 to 100, with 0 representing no disability, and 100 representing full disability.
- Instrumented 2-Minute Step Test with Inertial Measurement Unit Data [ Time Frame: Single time point measured in subset of participants at 6 months ]A subset of local participants will complete an instrumented 2-Minute Step Test in-person. The inertial measurement unit enabled ActiGraph GT9X Link will be affixed to the shoe of the participant and will collect data throughout the 2-Minute Step Test. Number of steps taken during the two-minute period will be directly counted by a tester and simultaneously measured from inertial measurement unit data. Specifically, vertical displacement of the foot will be measured using the nine degrees of freedom inertial measurement unit functionality (three degrees of freedom each for accelerometer, gyroscope, and magnetometer) of the Actigraph GT9X Link. A step will be counted if the foot is vertically displaced by a defined threshold of distance midway between the knee joint and iliac crest.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05412550
|Contact: Cory L Christiansen, PhD||(303) 724-9101||Cory.Christiansen@va.gov|
|Contact: Emily R Hager, BS MS||(303) firstname.lastname@example.org|
|United States, Colorado|
|Rocky Mountain Regional VA Medical Center, Aurora, CO||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Thomas Fields, DPT 720-723-3372 email@example.com|
|Contact: Emily R Hager, BS MS (303) 724-6035 firstname.lastname@example.org|
|Principal Investigator: Cory L. Christiansen, PhD|
|Principal Investigator:||Cory L. Christiansen, PhD||Rocky Mountain Regional VA Medical Center, Aurora, CO|