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

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.

Study Overview

• Status: Recruiting
• Conditions: OSA; COPD
• Intervention / Treatment: Behavioral: Exercise

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 Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kimberly L Birkett, MPH BS; Phone Number: 4534 (540) 982-2463; Email: kimberly.birkett@va.gov
• Study Contact Backup: Name: Madalina Macrea, MD PhD; Email: Madalina.Macrea@va.gov

Study Locations

• United States
  • Virginia
    • Salem, Virginia, United States, 24153-6404
      • Recruiting
      • Salem VA Medical Center, Salem, VA
      • Contact: Tracy A Hicks; Phone Number: 1568 540-982-2463; Email: Tracy.Hicks2@va.gov
      • Contact: Donna J Arsura; Phone Number: 1225 (540) 982-2463; Email: donna.arsura@va.gov
      • Principal Investigator: Madalina Macrea, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Behavioral: 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; Other Names: MIIT
No Intervention: Usual Care; Participants in the control group will be instructed to maintain their routine activity level for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Madalina Macrea, MD PhD, Salem VA Medical Center, Salem, VA

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: February 14, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: COPD; OSA; Overlap Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: E3535-W; 1IK2RX003535 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No