The Epigenetics of Exercise and Physical Activity in COPD

NCT03539042 | Unknown

• 1 other identifier: 3013
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Copd

Keywords

DNA methylation; Physical activity; Exercise capacity

Outcome Measures

Primary Outcomes (1)

• Change in DNA methylation patterns

  Baseline patterns and changes over time after participation in exercise training

  Baseline and 3-month follow up

Secondary Outcomes (2)

• Change in 6MWD

  Baseline and 3-month follow up

• Change in average daily step count

  Baseline and 3-month follow up

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Boston Healthcare System: lead

Study Sites (1)

VA Boston Healthcare System

Boston, Massachusetts, 02130, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood and urine will be collected at 2 time points via venipuncture. Plasma and buffy coat will be extracted and stored for analysis at the conclusion of the study. Participation in this study will not impact the course of usual clinical care (observational study).

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Emily S Wan, MD,MPH

  VA Boston Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician and Principal Investigator

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: May 29, 2018
• Study Start: March 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: June 30, 2021
• Last Updated: May 30, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: 3 years
• Access Criteria: Prospective researchers must complete VA-required trainings in HIPAA, information security, and CITI training.

Locations

US (1)