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

Primary Purpose

COPD, OSA, Home Exercise

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
Salem Veterans Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD focused on measuring overlap, exercise, inflammation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Salem VAMCRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

After home exercise program

Arm Description

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)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
December 21, 2017
Last Updated
February 9, 2018
Sponsor
Salem Veterans Affairs Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03431103
Brief Title
The Effect of Exercise on Systemic Inflammation in Veterans With COPD and OSA
Official Title
The Effect of Exercise on Systemic Inflammation in Veterans With COPD and OSA
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 5, 2016 (Actual)
Primary Completion Date
May 1, 2019 (Anticipated)
Study Completion Date
May 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Salem Veterans Affairs Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, OSA, Home Exercise, Inflammation
Keywords
overlap, exercise, inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
After home exercise program
Arm Type
Other
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
12 week home exercise program
Primary Outcome Measure Information:
Title
To assess the relationship between baseline physical activity (meters obtained from 6 minute walk test) and serum hs-CRP (mg/L)
Description
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)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
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)
Description
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
Time Frame
3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristine Allred
Phone
540-982-2463
Ext
4044
Email
kristine.allred@va.gov
Facility Information:
Facility Name
Salem VAMC
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristine Allred
Phone
540-982-2463
Ext
4044
Email
kristine.allred@va.gov

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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