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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 3 months

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.

Do I qualify?Apply below to find out