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Wearable Sensors for Monitoring Exercise Response in COPD

Phase 1 & 2
Recruiting
Led By Bijan Najafi, PhD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will use wearable sensors to track changes in cognitive-motor performance in response to COPD, CHF, or an exercise intervention.

Who is the study for?
This trial is for veterans aged 18 or older with chronic illnesses like COPD or CHF, who can walk at least 10 meters and are enrolled in VA-Houston's tele-rehabilitation programs. It excludes those unable to walk, unlikely to follow the protocol, unwilling to consent, on unstable medications, with severe cognitive issues or psychiatric problems affecting participation.
What is being tested?
The study tests if wearable sensors can monitor motor-cognitive performance changes due to chronic diseases like COPD/CHF. It will also assess if exercise via tele-rehabilitation improves these functions. Participants' movements and balance will be tracked using devices such as LEGSys and BalanSENS.
What are the potential side effects?
Since the intervention involves exercise provided through tele-rehabilitation, potential side effects may include typical exercise-related risks such as muscle soreness, fatigue, shortness of breath (especially in patients with lung disease), joint pain or discomfort.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline balance at 12 weeks
Change from baseline frailty index at 12 weeks
Change from baseline gait speed at 12 weeks
Secondary study objectives
Change from baseline Fear of Falling at 12 weeks
Change from baseline Risk of falling at 12 weeks
Cognition
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tele-rehabilitation exercise GroupExperimental Treatment1 Intervention
Participants who are suffering from a chronic illness such as COPD or CHF and are referred for tele-rehabilitation intervention at the VA-Houston will be qualified for the purpose of this study.

Find a Location

Who is running the clinical trial?

Michael E. DeBakey VA Medical CenterFED
67 Previous Clinical Trials
17,079 Total Patients Enrolled
Baylor College of MedicineLead Sponsor
1,028 Previous Clinical Trials
6,030,012 Total Patients Enrolled
Bijan Najafi, PhDPrincipal Investigator - Baylor College of Medicine
Baylor College of Medicine
8 Previous Clinical Trials
511 Total Patients Enrolled

Media Library

Exercise Clinical Trial Eligibility Overview. Trial Name: NCT04306588 — Phase 1 & 2
Restrictive Lung Disease Research Study Groups: Tele-rehabilitation exercise Group
Restrictive Lung Disease Clinical Trial 2023: Exercise Highlights & Side Effects. Trial Name: NCT04306588 — Phase 1 & 2
Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT04306588 — Phase 1 & 2
~20 spots leftby Dec 2025
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