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| ID | Type | Description | Link |
|---|---|---|---|
| 1IK2RX003535 | U.S. NIH Grant/Contract | View source |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Usual Care | No Intervention | Participants in the control group will be instructed to maintain their routine activity level for 12 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Madalina Macrea, MD PhD | Contact | Madalina.Macrea@va.gov | ||
| Kimberly L Birkett, MPH BS | Contact | (540) 982-2463 | 4534 | kimberly.birkett@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Madalina Macrea, MD PhD | Salem VA Medical Center, Salem, VA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salem VA Medical Center, Salem, VA | Recruiting | Salem | Virginia | 24153-6404 | United States |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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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
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |