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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05254431
• Other study ID #: E3535-W
• Secondary ID: 1IK2RX003535
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: April 1, 2026

Study information

• Verified date: May 2024
• Source: VA Office of Research and Development
• Contact: Tracy A Hicks
• Phone: (540) 982-2463
• Email: Tracy.Hicks2[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• COPD
• OSA

Intervention

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

Locations

Country	Name	City	State
United States	Salem VA Medical Center, Salem, VA	Salem	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Concentration of Serum hs-CRP (mg/dL)	Change from baseline in Serum hs-CRP (mg/dL) at 12 weeks	12 weeks