COPDNCT05254431
The Effect of Interval Exercise on Functional Outcomes in Veterans With COPD and OSA
A study testing Exercise in people with COPD and OSA, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Madalina Macrea, MD PhD contact
United States1 site, 1 recruiting
- Recruiting
Salem VA Medical Center, Salem, VA
Salem, Virginia, 24153-6404
Tracy A Hicks, 540-982-2463 ext. 1568, Tracy.Hicks2@va.gov
Donna J Arsura, (540) 982-2463 ext. 1225, donna.arsura@va.gov
About this study
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.
Read the detailed description
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. Veterans with OS who also have excessive daytime sleepiness (EDS-OS) are at highest risk for functional decline yet have the greatest barriers to exercise training. Thus, there is a critical need to identify novel exercise strategies that meet the individual needs and capacities of Veterans with EDS-OS. The investigators propose to test moderate intensity interval training (MIIT), a novel exercise intervention whose translation into durable lifestyle change may be facilitated by the feasibility of short bouts of increased PA. The investigators proposal addresses key knowledge gaps in rehabilitation research by investigating the clinical phenotype of EDS-OS to determine the association with functional outcomes and response to a novel exercise intervention with the goal to reduce functional decline.
- Being tested
- Exercise
- Keywords
- COPD, OSA, Overlap Syndrome
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Also called MIIT
Novel Moderate Intensity Interval Exercise
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
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | 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 Receives: Behavioral: Exercise |
| Usual Care | No intervention | Participants in the control group will be instructed to maintain their routine activity level for 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale number on Epworth Sleepiness Scale
Change from baseline ESS at 12 weeks ESS is daytime sleepiness scale, lower numbers better Scale goes from 0- not sleepy at all; to 20 -very sleepy
Measured: 12 weeks
Number of Daily Steps
Change from baseline in Daily Steps at 12 weeks All participants will wear a wrist accelerometer (ActiGraph wGT3X-BT) for 7 days at baseline and the end of intervention phase to record daily steps. ActiLife software will be used to run validation algorithms and calculate mean daily steps.
Measured: 12 weeks
Concentration of Serum hs-CRP (mg/dL)
Change from baseline in Serum hs-CRP (mg/dL) at 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start1 Apr 2022
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Exercise trial of 12 weeks moderate intensity interval exercise in Veterans with COPD and OSA that compares exercise group to standard of care control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Madalina Macrea, MD PhD, Principal investigator, Salem VA Medical Center, Salem, VA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254431
- Sponsor's protocol ID
- E3535-W
- Other IDs
- 1IK2RX003535
- Status last verified
- Apr 2026
- First submitted
- 28 Jan 2022
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Interval Exercise on Functional Outcomes in Veterans With COPD and OSA
- ClinicalTrials.gov ID
- NCT05254431
- Acronym / sponsor ID
- E3535-W
- Keywords
- COPD, OSA, Overlap Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Veterans with OS who also have excessive daytime sleepiness (EDS-OS) are at highest risk for functional decline yet have the greatest barriers to exercise training. Thus, there is a critical need to identify novel exercise strategies that meet the individual needs and capacities of Veterans with EDS-OS. The investigators propose to test moderate intensity interval training (MIIT), a novel exercise intervention whose translation into durable lifestyle change may be facilitated by the feasibility of short bouts of increased PA. The investigators proposal addresses key knowledge gaps in rehabilitation research by investigating the clinical phenotype of EDS-OS to determine the association with functional outcomes and response to a novel exercise intervention with the goal to reduce functional decline.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Exercise trial of 12 weeks moderate intensity interval exercise in Veterans with COPD and OSA that compares exercise group to standard of care control group
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExerciseThe 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 |
| Usual Care | No intervention | –Participants in the control group will be instructed to maintain their routine activity level for 12 weeks |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: MIITNovel Moderate Intensity Interval Exercise 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 | Behavioural | Exercise |
Primary outcome
Scale number on Epworth Sleepiness Scale
Time frame: 12 weeks
Change from baseline ESS at 12 weeks ESS is daytime sleepiness scale, lower numbers better Scale goes from 0- not sleepy at all; to 20 -very sleepy
Number of Daily Steps
Time frame: 12 weeks
Change from baseline in Daily Steps at 12 weeks All participants will wear a wrist accelerometer (ActiGraph wGT3X-BT) for 7 days at baseline and the end of intervention phase to record daily steps. ActiLife software will be used to run validation algorithms and calculate mean daily steps.
Concentration of Serum hs-CRP (mg/dL)
Time frame: 12 weeks
Change from baseline in Serum hs-CRP (mg/dL) at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Madalina Macrea, MD PhD contact
Madalina Macrea, MD PhD principal investigator
Salem VA Medical Center, Salem, VA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with COPD and OSA, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madalina Macrea, MD PhD (Madalina.Macrea@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scale number on Epworth Sleepiness Scale (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.