The Epigenetics of Exercise and Physical Activity in COPD

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.

Study Overview

• Status: Unknown
• Conditions: Copd

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02130
      • VA Boston Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study will recruit from Veterans referred to the VA Boston Pulmonary Rehabilitation Program who have a confirmed diagnosis of COPD.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in DNA methylation patterns	Baseline patterns and changes over time after participation in exercise training	Baseline and 3-month follow up

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: VA Boston Healthcare System
• Investigators: Principal Investigator: Emily S Wan, MD,MPH, VA Boston Healthcare System

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: May 1, 2018
• First Submitted That Met QC Criteria: May 24, 2018
• First Posted (Actual): May 29, 2018

Study Record Updates

• Last Update Posted (Actual): May 30, 2018
• Last Update Submitted That Met QC Criteria: May 25, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Physical activity; DNA methylation; Exercise capacity
• Other Study ID Numbers: 3013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual level data will be entered into an approved research repository behind the VA firewall. Data will be shared with qualified researchers (see below)
• IPD Sharing Time Frame: 3 years
• IPD Sharing Access Criteria: Prospective researchers must complete VA-required trainings in HIPAA, information security, and CITI training.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No