The Effect of Interval Exercise on Functional Outcomes in Veterans With COPD and OSA
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- No age limits stated
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 20 years
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Due to premature aging, patients with OS are prone to developing functional decline up to 20 years earlier than the general population."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how exercise done in intervals affects daily life, physical activity, and heart health. It is for Veterans with both COPD, a lung disease that makes breathing hard, and obstructive sleep apnea, which causes breathing to stop and start during sleep.
The term "Overlap Syndrome" (OS) is used to describe the presence of both chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) in a single patient. Due to premature aging, patients with OS are prone to developing functional decline up to 20 years earlier than the general population. The International Classification of Functioning, Disability and Health (ICF) evaluates functional status in chronic pulmonary disease globally in 5 domains. The investigators propose to study validated outcomes in 3 of these domains: 1) participation in life situations; 2) physical activity; and 3) cardiovascular health. The investigators long-term goal is to develop an exercise strategy tailored to Veterans with OS which will reduce the risk of functional decline through increased PA.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have both COPD and obstructive sleep apnea, confirmed by breathing tests and a sleep study in your medical record.
- Score above 20 on the Montreal Cognitive Assessment, a test of memory and thinking.
Who can't join
- Have coronary artery disease, a disease of the blood vessels that supply the heart. Signs include past heart bypass surgery, a heart attack, heart-related chest pain, or a stress test showing low blood flow to the heart.
- Have joint pain that limits walking.
- Have had more than 2 falls in the past month.
- Have been in the hospital in the past month.
- Use oxygen at home during the day.
- Take part in structured exercise, defined as more than 1 hour of moderate activity and any hard activity in the past 7 days.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Diagnosis of COPD and OSA, i.e., Overlap Syndrome Diagnosis of Overlap Syndrome (both COPD and OSA), confirmed in CPRS from spirometry or pulmonary function test of FEV1/FVC \<70 for COPD and a polysomnogram or home-based study for OSA. * Montreal Cognitive Assessment (MoCA) \>20 Exclusion Criteria: * CAD, as defined by anyone of the following: history of CABG, prior positive stress test for ischemia, infarction or angina or medical problem * Orthopedic problems as defined by joint pain limiting ambulation * Fall risk, defined as more than 2 falls in the prior month * Hospitalization in prior month * Daytime home oxygen 6. Participation in structured exercise, defined by the Physical Activity Scale for the Elderly (PASE) as more than 1 hour of activity spent in moderate activity and any strenuous activity performed over prior 7 days.
Study sites (1)
VA
- Salem VA Medical Center, Salem, VA · Salem, VA 24153-6404Tracy A Hicks · Study contact · 540-982-2463 ext. 1568 · Tracy.Hicks2@va.govDonna J Arsura · Study contact · (540) 982-2463 ext. 1225 · donna.arsura@va.govMadalina Macrea, MD PhD · Principal investigatorMore trials in Salem