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Telehealth Walking Exercise for Lower Limb Amputation (WEST Trial)
N/A
Recruiting
Led By Cory L. Christiansen, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion: baseline to 18 months
Awards & highlights
WEST Trial Summary
This trial will help improve outcomes for Veterans with lower-limb amputations by testing a walking exercise self-management program to see if it leads to sustained exercise participation.
Who is the study for?
This trial is for Veterans with lower-limb amputations who can walk for two minutes using a prosthesis and assistive device if needed, and manage daily living activities without help. It's not suitable for those with mild cognitive impairment, active cancer treatment, congenital or cancer-related amputation, acute infections, prisoners, or unstable heart conditions.Check my eligibility
What is being tested?
The study tests an 18-month walking exercise self-management program delivered through telehealth to encourage sustained exercise in Veterans with lower-limb amputations. The goal is to reduce sedentary behavior by providing individualized training and peer support.See study design
What are the potential side effects?
Since the intervention involves exercise management rather than medication or medical procedures, side effects are minimal but may include typical risks associated with starting a new exercise routine such as muscle soreness or strain.
WEST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had one or both of my legs amputated.
Select...
I can walk for two minutes without sitting down, using aids if necessary.
Select...
I can take care of my daily needs without help.
WEST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion: baseline to 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion: baseline to 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average Daily Step Count
Secondary outcome measures
2-Minute Step Test
30-Second Chair Rise Test
Comprehensive Lower Limb Amputee Socket Survey (CLASS)
+4 moreOther outcome measures
Instrumented 2-Minute Step Test with Inertial Measurement Unit Data
WEST Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Exercise self-managementExperimental Treatment1 Intervention
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.
Group II: Attention controlActive Control1 Intervention
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The Walking Exercise Self-Management Program for lower limb amputation patients focuses on behavior change through self-management training and peer support. This approach involves creating individualized exercise plans, remote monitoring, and providing peer support to encourage adherence and motivation.
These mechanisms are essential as they address both physical and psychological barriers to exercise, which are common in lower limb amputation patients. By promoting consistent physical activity, the program aims to improve functional capacity, reduce disability, and enhance overall quality of life.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,621 Previous Clinical Trials
3,323,423 Total Patients Enrolled
1 Trials studying Lower Limb Amputation
20 Patients Enrolled for Lower Limb Amputation
Cory L. Christiansen, PhDPrincipal InvestigatorRocky Mountain Regional VA Medical Center, Aurora, CO
3 Previous Clinical Trials
199 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently receiving treatment for cancer.I have had one or both of my legs amputated.I do not have any current severe heart problems or infections.I can walk for two minutes without sitting down, using aids if necessary.I have had an amputation due to birth defects or cancer.I can take care of my daily needs without help.
Research Study Groups:
This trial has the following groups:- Group 1: Exercise self-management
- Group 2: Attention control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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