CopdNCT03539042
The Epigenetics of Exercise and Physical Activity in COPD
An observational study of Copd, run by VA Boston Healthcare System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Copd
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will recruit from Veterans referred to the VA Boston Pulmonary Rehabilitation Program who have a confirmed diagnosis of COPD.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System
Boston, Massachusetts, 02130
About this study
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.
Read the 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.
- Conditions
- Copd
- Keywords
- DNA methylation, Physical activity, Exercise capacity
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in DNA methylation patterns
Baseline patterns and changes over time after participation in exercise training
Measured: Baseline and 3-month follow up
Secondary outcomes (2)
Change in 6MWD
Change in exercise capacity (assessed as 6 minute walk distance) after exercise training in pulmonary rehabilitation
Measured: 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
Measured: Baseline and 3-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start1 Mar 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CopdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Boston Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Emily S. Wan, VA Boston Healthcare System
- Investigators
- Emily S Wan, MD,MPH, Principal investigator, VA Boston Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539042
- Sponsor's protocol ID
- 3013
- Status last verified
- May 2018
- First submitted
- 1 May 2018
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual level data will be entered into an approved research repository behind the VA firewall. Data will be shared with qualified researchers (see below)
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Epigenetics of Exercise and Physical Activity in COPD
- ClinicalTrials.gov ID
- NCT03539042
- Acronym / sponsor ID
- 3013
- Conditions
- Copd
- Keywords
- DNA methylation, Physical activity, Exercise capacity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- VA Boston Healthcare SystemUS federal agency
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 29 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will recruit from Veterans referred to the VA Boston Pulmonary Rehabilitation Program who have a confirmed diagnosis of COPD.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in DNA methylation patterns
Time frame: Baseline and 3-month follow up
Baseline patterns and changes over time after participation in exercise training
2 secondary outcomes
Change in 6MWD
Time frame: Baseline and 3-month follow up
Change in average daily step count
Time frame: Baseline and 3-month follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Individual participant dataSharing planned: Yes. Individual level data will be entered into an approved research repository behind the VA firewall. Data will be shared with qualified researchers (see below)
Related trials for Copd
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
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Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily S Wan, MD,MPH principal investigator
VA Boston Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Copd, run by VA Boston Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in DNA methylation patterns (time frame: Baseline and 3-month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2018.