Recruiting

Exercise

Sponsor:

Salem Veterans Affairs Medical Center

Code:

NCT03431103

Conditions

COPD

OSA

Home Exercise

Inflammation

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Exercise

Study Details

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.

Conditions

COPD

OSA

Home Exercise

Inflammation

Study ID

NCT03431103

Start date

Dec 5, 2016

Status verified date

Feb, 2018

Completion date

May 1, 2019

Anticipated

Primary completion date

May 1, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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)

Interventions

Exercise

12 week home exercise program

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Kristine Allred

540-982-2463kristine.allred@va.gov

Locations

Salem VAMC

Recruiting

Salem, Virginia, United States, 24153

Contacts

Kristine Allred

540-982-2463kristine.allred@va.gov

More Information

Sponsor

Salem Veterans Affairs Medical Center

Last update posted

Feb 13, 2018

Last verified

Feb, 2018

Keywords

  • overlap
  • exercise
  • inflammation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Salem Veterans Affairs Medical Center on 2018-02-13.