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

NCT03431103 | Unknown DMC

• 1 other identifier: MM 0013
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

overlap; exercise; inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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)

  3 months

Study Arms (1)

After home exercise program

OTHER

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

Interventions

Exercise BEHAVIORAL

12 week home exercise program

After home exercise program

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Salem Veterans Affairs Medical Center: lead

Study Sites (1)

Salem VAMC

Salem, Virginia, 24153, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Inflammation; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Kristine Allred

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2017
• First Posted: February 13, 2018
• Study Start: December 5, 2016
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: February 13, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)