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Interval Exercise for COPD and Sleep Apnea

N/A

Recruiting

Led By Madalina Macrea, MD 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

Must not have

CAD, as defined by history of CABG, prior positive stress test for ischemia, infarction or angina

Orthopedic problems as defined by joint pain limiting ambulation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying an exercise strategy to help reduce functional decline in veterans with both chronic obstructive pulmonary disease and obstructive sleep apnea.

Who is the study for?

This trial is for veterans with Overlap Syndrome, which means they have both COPD and OSA. They must show cognitive function with a MoCA score over 20. Those who already do structured exercise, need daytime oxygen, have recent heart issues or hospitalization, orthopedic problems limiting walking, or a high fall risk cannot join.

What is being tested?

The study aims to develop an exercise program specifically for veterans with Overlap Syndrome to prevent early functional decline. It will measure the impact of interval exercise on participation in life situations, physical activity levels, and cardiovascular health.

What are the potential side effects?

While not explicitly stated in the provided information, typical side effects from starting an exercise regimen may include muscle soreness, fatigue, shortness of breath especially if participants have pre-existing lung conditions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of heart issues like bypass surgery or heart attack.

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I have joint pain that makes it hard for me to walk.

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I have fallen more than twice in the last month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Concentration of Serum hs-CRP (mg/dL)

Number of Daily Steps

Scale number on Epworth Sleepiness Scale

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ExerciseExperimental Treatment1 Intervention

The Experimental Design is a randomized trial of Moderate intensity interval training (5-minute intervals at 50% VO2peak 3 times weekly for 12 weeks) in Veterans with COPD and OSA compared with standard of care controls

Group II: Usual CareActive Control1 Intervention

Participants in the control group will be instructed to maintain their routine activity level for 12 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise

2016

Completed Phase 1

~820

0 / 3Eligibility criteria met