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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Concentration of Serum hs-CRP (mg/dL)
Number of Daily Steps
Scale number on Epworth Sleepiness Scale
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
~760
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,610 Previous Clinical Trials
3,305,156 Total Patients Enrolled
Madalina Macrea, MD PhDPrincipal InvestigatorSalem VA Medical Center, Salem, VA
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with both COPD and sleep apnea.I have been diagnosed with COPD and OSA based on specific lung and sleep tests.I have a history of heart issues like bypass surgery or heart attack.I have joint pain that makes it hard for me to walk.I use oxygen at home during the day.I was hospitalized in the last month.I have fallen more than twice in the last month.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care
- Group 2: Exercise
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are currently participating in this investigation?
"Affirmative. The details provided on clinicaltrials.gov reveal that the enrollment phase of this medical trial is underway, with 28 participants being recruited from 1 site since its inception on April 1st 2022 and last update on April 20th 2022."
Answered by AI
Are any more individuals being admitted to this clinical research program?
"That is true. According to the information furnished on clinicaltrials.gov, this trial has been recruiting since April 1st 2022 and the latest update was made on April 20th of that same year. The experiment requires 28 volunteers from a single medical facility."
Answered by AI
Who else is applying?
What state do they live in?
Texas
Pennsylvania
California
How old are they?
18 - 65
What site did they apply to?
Salem VA Medical Center, Salem, VA
What portion of applicants met pre-screening criteria?
Did not meet criteria
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