COPDNCT02399254
The Trajectory of Physical Activity Following Pulmonary Rehabilitation
An observational study of COPD and Pulmonary Disease, Chronic Obstructive, run by Trinity Health Of New England at 4 sites in United States.
Trial summary
Pulmonary rehabilitation clearly increases exercise capacity, but its effect on physical activity in the home and community settings is less clear. It may take a longer time for this increase in physical activity to occur. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, Pulmonary Disease, Chronic Obstructive
- How many people
- 21 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2015to 15 Jun 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Pulmonary Rehabilitation Center
Who may be able to join
- Adults (≥ 40 years) with a primary clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
- A post-bronchodilator forced expiratory volume in one second(FEV1)/forced vital capacity (FVC) < 0.70 from spirometry performed within the preceding 12 months (no specific FEV1 percent-predicted requirement, although we anticipate the FEV1 will average around 45% of predicted, based on previous studies of pulmonary rehabilitation)
- The patient was referred to pulmonary rehabilitation
- The patient is clinically-stable: no exacerbation in preceding 4 weeks
- Modified Medical Research Council (mMRC) dyspnea rating of at least 2 out of 5.
Who cannot join
- Disease severity or co-morbidity that would make the patient be at-risk for participation this study
- A significant movement disorder, such as hemiplegia, etc.
- Inability to read and comprehend the questionnaires, which will be in English
- A history of poor wound healing or chronic skin conditions that might predispose to local problems from wearing the DynaPort. (The DynaPort can be worn outside a thin garment, such as a tee shirt, and is relatively thin, without protruding parts. However, since the device may be worn overnight, and there is a remote risk of pressure problems, this exclusion criterion was added).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Saint Francis Hospital and Medical Center
Hartford, Connecticut, 06105
Ocean State Research Institute
Providence, Rhode Island, 02908
Gaylord Hospital
Wallingford, Connecticut, 06492
VA Connecticut Research and Education Foundation
West Haven, Connecticut, 06516
About this study
Pulmonary rehabilitation clearly increases exercise capacity, but its effect on physical activity in the home and community settings is less clear. It may take a longer time for this increase in physical activity to occur. It has been stated in an editorial that it takes 3 months to train the muscles but 6 months to train the brain. The Investigators will first evaluate the change in physical activity following pulmonary rehabilitation using state-of-the-science motion detectors, then Investigators will follow the trajectory of physical activity over the next several months.
Read the detailed description
This study will follow physical activity following pulmonary rehabilitation longitudinally over 48 weeks. Investigators will use a state-of-the-art accelerometer, to analyze minutes walking per day as the primary outcome, rather than vector magnitude units (VMU) or estimated steps per day. Investigators will explore potential factors influencing this important outcome, including baseline activity levels, demographic variables, changes in exercise capacity, psychological variables, and self-efficacy scores. Finally, Investigators will evaluate the rate of change (trajectory) in physical activity over approximately six months after pulmonary rehabilitation. There are limited data suggesting it takes time for the translation of increased exercise capacity into increased physical activity to occur.
- Conditions
- COPD, Pulmonary Disease, Chronic Obstructive
- Keywords
- Pulmonary Rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Rehabilitation | Chronic Obstructive Pulmonary Disease (COPD) patients following pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minutes/Day at 12 Weeks
Investigators will look at changes in directly-measured physical activity (minutes per day of walking activity from the DynaPort) between the 12 ± 3 week assessment and baseline.
Measured: 12 weeks compared to baseline
Minutes/Day at 48 Weeks
Investigators will look at changes in directly-measured physical activity (minutes per day of walking activity from the DynaPort) between the 48 ± 3 week assessment and baseline.
Measured: 48 weeks compared to baseline
Secondary outcomes (2)
Activity-related Energy Expenditure (AEE)(J/Min/kg) at 12 Weeks
Investigators will look at changes in activity-related energy expenditure (from the DynaPort) at 12 weeks compared to baseline
Measured: 12 weeks compared to baseline
Activity-related Energy Expenditure (AEE)(J/Min/kg) at 48 Weeks
Investigators will look at changes in activity-related energy expenditure (from the DynaPort) at 48 weeks compared to baseline
Measured: 48 weeks compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startApr 2015
- Primary completion15 Jun 2017
- Study completion15 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trinity Health Of New England
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard ZuWallack, MD, Principal investigator, Saint Francis Hospital and Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399254
- Sponsor's protocol ID
- 14-06-001 E
- Status last verified
- Apr 2019
- First submitted
- 16 Mar 2015
- Last updated
- 6 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Trajectory of Physical Activity Following Pulmonary Rehabilitation
- ClinicalTrials.gov ID
- NCT02399254
- Acronym / sponsor ID
- 14-06-001 E
- Conditions
- COPD, Pulmonary Disease, Chronic Obstructive
- Keywords
- Pulmonary Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Trinity Health Of New EnglandUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 15 Jun 2017 (actual)
- First posted
- 26 Mar 2015 (estimated)
- Results
- Posted 8 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pulmonary rehabilitation clearly increases exercise capacity, but its effect on physical activity in the home and community settings is less clear. It may take a longer time for this increase in physical activity to occur. It has been stated in an editorial that it takes 3 months to train the muscles but 6 months to train the brain. The Investigators will first evaluate the change in physical activity following pulmonary rehabilitation using state-of-the-science motion detectors, then Investigators will follow the trajectory of physical activity over the next several months.
Detailed description
This study will follow physical activity following pulmonary rehabilitation longitudinally over 48 weeks. Investigators will use a state-of-the-art accelerometer, to analyze minutes walking per day as the primary outcome, rather than vector magnitude units (VMU) or estimated steps per day. Investigators will explore potential factors influencing this important outcome, including baseline activity levels, demographic variables, changes in exercise capacity, psychological variables, and self-efficacy scores. Finally, Investigators will evaluate the rate of change (trajectory) in physical activity over approximately six months after pulmonary rehabilitation. There are limited data suggesting it takes time for the translation of increased exercise capacity into increased physical activity to occur.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Rehabilitation | – | –Chronic Obstructive Pulmonary Disease (COPD) patients following pulmonary rehabilitation |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pulmonary Rehabilitation Center
Key inclusion criteria (5 listed)
- Adults (≥ 40 years) with a primary clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
- A post-bronchodilator forced expiratory volume in one second(FEV1)/forced vital capacity (FVC) < 0.70 from spirometry performed within the preceding 12 months (no specific FEV1 percent-predicted requirement, although we anticipate the FEV1 will average around 45% of predicted, based on previous studies of pulmonary rehabilitation)
- The patient was referred to pulmonary rehabilitation
- The patient is clinically-stable: no exacerbation in preceding 4 weeks
- Modified Medical Research Council (mMRC) dyspnea rating of at least 2 out of 5.
Key exclusion criteria (4 listed)
- Disease severity or co-morbidity that would make the patient be at-risk for participation this study
- A significant movement disorder, such as hemiplegia, etc.
- Inability to read and comprehend the questionnaires, which will be in English
- A history of poor wound healing or chronic skin conditions that might predispose to local problems from wearing the DynaPort. (The DynaPort can be worn outside a thin garment, such as a tee shirt, and is relatively thin, without protruding parts. However, since the device may be worn overnight, and there is a remote risk of pressure problems, this exclusion criterion was added).
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
Minutes/Day at 12 Weeks
Time frame: 12 weeks compared to baseline
Investigators will look at changes in directly-measured physical activity (minutes per day of walking activity from the DynaPort) between the 12 ± 3 week assessment and baseline.
Minutes/Day at 48 Weeks
Time frame: 48 weeks compared to baseline
Investigators will look at changes in directly-measured physical activity (minutes per day of walking activity from the DynaPort) between the 48 ± 3 week assessment and baseline.
2 secondary outcomes
Activity-related Energy Expenditure (AEE)(J/Min/kg) at 12 Weeks
Time frame: 12 weeks compared to baseline
Activity-related Energy Expenditure (AEE)(J/Min/kg) at 48 Weeks
Time frame: 48 weeks compared to baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Richard ZuWallack, MD principal investigator
Saint Francis Hospital and Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Pulmonary Disease, Chronic Obstructive, run by Trinity Health Of New England at 4 sites 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 8 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Minutes/Day at 12 Weeks (time frame: 12 weeks compared to baseline). The study lists 2 primary outcomes in all. 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 6 Aug 2019.