Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-25 @ 5:17 PM
Study NCT ID:
NCT03431103
Status:
UNKNOWN
Last Update Posted:
2018-02-13
First Post:
2017-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Exercise on Systemic Inflammation in Veterans With COPD and OSA
Sponsor:
Salem Veterans Affairs Medical Center
Organization:
Study Overview
Official Title:
The Effect of Exercise on Systemic Inflammation in Veterans With COPD and OSA
Status:
UNKNOWN
Status Verified Date:
2018-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overlap syndrome (OS), i.e. the association of both Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA) in a single Veteran, is prevalent and associated with increased cardiovascular disease (CVD) morbidity. Home-based exercise interventions that translate to a lifestyle with increased physical activity (PA) are an ideal strategy as 150 minutes of leisure time PA a week is associated with a significant reduction in risk of CVD related events and death. This novel research study will help develop a home exercise intervention that is largely accepted by OS Veterans, as a first step toward implementing PA into the routine medical care of the large Veteran population with COPD and OSA. This data will be used for larger studies on CVD risk and its modification with exercise in OS, a research area that is urgently needed given its high impact on Veterans' morbidity, mortality and health-care associated costs.
Detailed Description:
The term "overlap syndrome" (OS) is used to describe the association of both chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea disease (OSA) in a single Veteran. Given the high prevalence of both COPD and OSA, it is expected that a third of Veterans with OSA could be affected by OS. Importantly, Veterans with OS have a higher cardiovascular morbidity and mortality than either OSA or COPD-only Veterans, likely due to worse nocturnal hypoxia and subsequent inflammation and endothelial dysfunction. Therefore, therapy for Veterans with OS that decreases cardiovascular disease (CVD) by targeting inflammation is a high priority. Home-based exercise interventions that translate to a lifestyle with increased physical activity (PA) are an ideal strategy as 150 minutes of leisure time PA a week is associated with reduction in risk of CVD-related events and death. Further, PA decreases biomarkers of systemic inflammation. However, no data is available on the effect of exercise on biomarkers of systemic inflammation in Veterans with OS. It is difficult to increase the leisure time PA in adults with COPD and OSA as this population is more sedentary due to a combination of increased obesity, daytime sleepiness and dyspnea. Therefore, home-based exercise would be ideal for these Veterans. The objective of this proposal is to conduct a single arm 12-week home-based exercise pilot intervention to determine the effect on biomarkers of systemic inflammation in 50 Veterans with OS on CPAP. The investigator hypothesizes that 1) Baseline PA intensity and duration will correlate inversely with the biomarkers of systemic inflammation independently of nocturnal hypoxia; and 2) Exercise training using a home-based computer exercise program will decrease biomarkers of systemic inflammation and increase exercise capacity in Veterans.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: