The Epigenetics of Exercise and Physical Activity in COPD

Copd Clinical Trial

Official title:

The Epigenetics of Exercise and Physical Activity in COPD

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03539042
• Other study ID #: 3013
• Status: Enrolling by invitation
• Start date: March 1, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: May 2018
• Source: VA Boston Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: June 30, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Copd

Locations

Country	Name	City	State
United States	VA Boston Healthcare System	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Boston Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in DNA methylation patterns	Baseline patterns and changes over time after participation in exercise training	Baseline and 3-month follow up
Secondary	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
Secondary	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