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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 below
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I have had one or both of my legs amputated.
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I can walk for two minutes without sitting down, using aids if necessary.
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I can take care of my daily needs without help.

WEST Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion: baseline to 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion: baseline to 18 months for reporting.

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 more
Other 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.

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Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,525 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

Media Library

Exercise self-management Clinical Trial Eligibility Overview. Trial Name: NCT05412550 — N/A
Lower Limb Amputation Research Study Groups: Exercise self-management, Attention control
Lower Limb Amputation Clinical Trial 2023: Exercise self-management Highlights & Side Effects. Trial Name: NCT05412550 — N/A
Exercise self-management 2023 Treatment Timeline for Medical Study. Trial Name: NCT05412550 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To whom is this clinical experiment accessible?

"This research is looking for 78 elderly candidates (aged between 50 and 89) with a history of lower-limb amputation to take part. For eligibility, participants should have had either unilateral or bilateral limb removal due to trauma or non-trauma causes; be able to walk two minutes without breaks while using an assistive device if necessary; and live independently in their day-to-day life."

Answered by AI

Is this medical trial open to applicants beyond forty years of age?

"This investigation is recruiting those aged between 50 and 89 years old."

Answered by AI

Is this study enrolling volunteers at the moment?

"According to clinicaltrials.gov, the current status of this medical trial is "Recruiting". It was initially posted on November 1st 2022 and revised three days later on November 3rd."

Answered by AI

How many people are participating in this research endeavor?

"Affirmative. According to the information provided by clinicaltrials.gov, this medical study is actively looking for participants who can be recruited at a single site. The trial was initially posted on November 1st 2022 and its most recent update occurred on November 3rd of the same year with an expected recruitment total of 78 patients."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
How old are they?
18 - 65
What site did they apply to?
Rocky Mountain Regional VA Medical Center, Aurora, CO
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Walking Exercise Sustainability Through Telehealth for Veterans With Lower-limb Amputation
2022. "Walking Exercise Sustainability Through Telehealth for Veterans With Lower-limb Amputation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05412550.
~50 spots leftby Oct 2026
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