The Effect of Interval Exercise on Functional Outcomes in Veterans With COPD and OSA

NCT05254431 | Recruiting

• 2 other identifiers: E3535-W1IK2RX003535
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Keywords

COPD; OSA; Overlap Syndrome

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  12 weeks

• Concentration of Serum hs-CRP (mg/dL)

  Change from baseline in Serum hs-CRP (mg/dL) at 12 weeks

  12 weeks

Study Arms (2)

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

Behavioral: Exercise

Usual Care

NO INTERVENTION

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

Interventions

Exercise BEHAVIORAL

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

Also known as: MIIT

Exercise

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Salem VA Medical Center, Salem, VA

Salem, Virginia, 24153-6404, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Madalina Macrea, MD PhD

  Salem VA Medical Center, Salem, VA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madalina Macrea, MD PhD

CONTACT

Madalina.Macrea@va.gov

Kimberly L Birkett, MPH BS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 24, 2022
• Study Start: April 1, 2022
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)