The Epigenetics of Exercise and Physical Activity in COPD

• Conditions: Copd

• Registration Number: NCT03539042
• Lead Sponsor: VA Boston Healthcare System

Brief Summary

This study seeks to examine genome-wide DNA methylation patterns associated with physical activity and exercise capacity from peripheral blood collected from participants with chronic obstructive pulmonary disease (COPD) before and after participation in a structured 9-week outpatient pulmonary rehabilitation program.

Detailed Description

Individuals who are referred to pulmonary rehabilitation IN THE COURSE OF THEIR USUAL CLINICAL CARE will be invited to participate in this observational study. Participants who enroll in the study will undergo two in-person visits, once before initiating pulmonary rehabilitation classes and once at the conclusion of pulmonary rehabilitation classes. Participation in this study will not alter the course of the participants' usual clinical care.

Study Timeline

• Study Start: 2018-03-01
• Status Verified: 2018-05
• Study First Submitted: 2018-05-01
• Study First Submitted QC: 2018-05-24
• Last Update Submitted: 2018-05-25
• Study First Posted: 2018-05-29
• Last Update Posted: 2018-05-30
• Primary Completion: 2020-12-31
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age >40 years
• Diagnosis of COPD (defined as an FEV1/FVC<0.7 or evidence of emphysema on radiologist's read of a chest CT obtained in the course of patient's usual care)
• Referral to and participation in the VA Boston Pulmonary Rehabilitation program

Exclusion Criteria

• Active or unstable cardiac disease
• Inability to ambulate > 1 block
• Recent acute exacerbation of COPD (defined as new or increased dose of systemic steroids and/or antibiotics for pulmonary indications)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in DNA methylation patterns	Baseline and 3-month follow up	Baseline patterns and changes over time after participation in exercise training

Secondary Outcome Measures

Name	Time	Method
Change in average daily step count	Baseline and 3-month follow up	Change in pedometer assessed daily step count before and after exercise training in pulmonary rehabilitation
Change in 6MWD	Baseline and 3-month follow up	Change in exercise capacity (assessed as 6 minute walk distance) after exercise training in pulmonary rehabilitation

Trial Locations

Locations (1)

VA Boston Healthcare System; 🇺🇸 Boston, Massachusetts, United States