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

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.

Study Overview

• Status: Unknown
• Conditions: Inflammation; OSA; COPD; Home Exercise
• Intervention / Treatment: Behavioral: Exercise

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristine Allred; Phone Number: 4044 540-982-2463; Email: kristine.allred@va.gov

Study Locations

• United States
  • Virginia
    • Salem, Virginia, United States, 24153
      • Recruiting
      • Salem VAMC
      • Contact: Kristine Allred; Phone Number: 4044 540-982-2463; Email: kristine.allred@va.gov

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the relationship between baseline physical activity (meters obtained from 6 minute walk test) and serum hs-CRP (mg/L)	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)	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	3 months

Collaborators and Investigators

• Sponsor: Salem Veterans Affairs Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2016
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: December 21, 2017
• First Submitted That Met QC Criteria: February 9, 2018
• First Posted (Actual): February 13, 2018

Study Record Updates

• Last Update Posted (Actual): February 13, 2018
• Last Update Submitted That Met QC Criteria: February 9, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: exercise; inflammation; overlap
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: MM 0013

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