Recruiting

Interval Exercise

Sponsor:

VA Office of Research and Development

Code:

NCT05254431

Conditions

COPD

OSA

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Exercise

Study Details

Brief 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. 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.

Conditions

COPD

OSA

Study ID

NCT05254431

Start date

Apr 1, 2022

Status verified date

Apr, 2026

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

28 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: 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

no intervention: Usual Care

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

Interventions

Exercise

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

Primary outcome measure

  • Scale number on Epworth Sleepiness Scale [ Time Frame: 12 weeks ]
  • Number of Daily Steps [ Time Frame: 12 weeks ]
  • Concentration of Serum hs-CRP (mg/dL) [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Madalina Macrea, MD PhD

Madalina.Macrea@va.gov

Kimberly L Birkett, MPH BS

(540) 982-2463kimberly.birkett@va.gov

Locations

Salem VA Medical Center, Salem, VA

Recruiting

Salem, Virginia, United States, 24153-6404

Contacts

Tracy A Hicks

540-982-2463Tracy.Hicks2@va.gov

Donna J Arsura

(540) 982-2463donna.arsura@va.gov

Principal Investigator:

Madalina Macrea, MD PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Keywords

  • COPD
  • OSA
  • Overlap Syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-04-24.