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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

Study 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.Check my eligibility
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.See study design
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

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

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
64 Previous Clinical Trials
15,638 Total Patients Enrolled
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,062 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

Frequently Asked Questions

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

Are there any openings still available for this trial?

"Clinicaltrials.gov has reported that this clinical research is actively recruiting participants, having initially been posted on May 21st 2018 and last updated on February 24th 2022."

Answered by AI

What outcomes are investigators hoping to observe through this research endeavor?

"The primary purpose of this trial, observed over a baseline and 3-month period, is to evaluate changes in the gait speed of patients. Secondary objectives assess levels of depression using the Center for Epidemiological Depression Scale (CES-D) questionnaire; risk of falling with the timed Up and Go test; and fear of falling with Fall Efficacy Scale International (FES-I). Scores range from 0 - 60 on CES-D while FES-I scores vary between 16 - 64."

Answered by AI

What is the current quota of participants for this research endeavor?

"Affirmative. Per the information on clinicaltrials.gov, this medical experiment is currently seeking volunteers; it was initially posted in May of 2018 and last modified February 24th 2022. 150 participants will be required from a single site."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Michael E. DeBakey Veterans Affairs Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

To find new treatment for copd.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Accessing Mobility Using Wearable Sensors
Bijan Najafi, PhD 2018. "Accessing Mobility Using Wearable Sensors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04306588.
All > Lung Disease > Congestive Heart Failure
~33 spots leftby Dec 2025
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