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The Effect of Exercise on Systemic Inflammation in Veterans With COPD and OSA

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ClinicalTrials.gov Identifier: NCT03431103
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Salem Veterans Affairs Medical Center

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.

Condition or disease Intervention/treatment Phase
COPD OSA Home Exercise Inflammation Behavioral: Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Exercise on Systemic Inflammation in Veterans With COPD and OSA
Actual Study Start Date : December 5, 2016
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
After home exercise program
Patients will be instructed to use the Wii Fit for 20 minutes at least twice a week for 12 weeks using specific Wii Fit exercises while on the Wii pressure sensor floor mat. The Wii Fit exercises will be as follows: 1." Basic Run" (warm-up exercise by walking in place); 2."Bird's Eye, Bull's-Eye" (mostly arms, requires arm flipping); 3."Free Step" (lower extremity exercise); 4."Hula Hoop" (gyration exercise)
Behavioral: Exercise
12 week home exercise program




Primary Outcome Measures :
  1. To assess the relationship between baseline physical activity (meters obtained from 6 minute walk test) and serum hs-CRP (mg/L) [ Time Frame: 24 months ]
    We will measure baseline physical activity (meters obtained from 6 minute walk test) and serum hs-CRP (mg/L) prior to the home-based computer exercise program (Wii Fit)


Secondary Outcome Measures :
  1. To determine the impact of a 12-week home-based Wii Fit exercise program on physical activity (meters obtained from 6 minute walk test) and serum hs-CRP (mg/L) [ Time Frame: 3 months ]
    Physical activity (meters obtained from 6 minute walk test) and serum hs-CRP (mg/L) will be measured before and after a 12-week home-based Wii Fit exercise program



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veterans from the Salem VAMC pulmonary clinics will be screened for a diagnosis of OSA and treatment with CPAP therapy. In addition, an inclusion criterion also will be a recent PFT diagnostic of COPD (FEV1/FVC <0.7 and FEV1< 80%). Only Veterans with OS who are compliant with CPAP therapy will be enrolled in the study.

Exclusion Criteria:

  • orthopedic problems, fall-risk, balance problems;
  • any regular participation in structured exercise sessions;
  • other concomitant sleep disorder;
  • unstable cardiovascular or pulmonary disease;
  • acute infectious illness in the prior month;
  • hospitalization in prior month;
  • prescription of systemic glucocorticoids or immune-suppressive agents in the prior month and
  • weight above 330 pounds, the limit allowed by the Wii pressure sensor floor mat.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03431103


Contacts
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Contact: Kristine Allred 540-982-2463 ext 4044 kristine.allred@va.gov

Locations
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United States, Virginia
Salem VAMC Recruiting
Salem, Virginia, United States, 24153
Contact: Kristine Allred    540-982-2463 ext 4044    kristine.allred@va.gov   
Sponsors and Collaborators
Salem Veterans Affairs Medical Center

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Responsible Party: Salem Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT03431103     History of Changes
Other Study ID Numbers: MM 0013
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Salem Veterans Affairs Medical Center:
overlap
exercise
inflammation

Additional relevant MeSH terms:
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Inflammation
Pathologic Processes