Hartford, Connecticut 06105

  • Pulmonary Disease, Chronic Obstructive

Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: 1. Adults (≥ 40 years) with a primary clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD) 2. 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) 3. The patient was referred to pulmonary rehabilitation 4. The patient is clinically-stable: no exacerbation in preceding 4 weeks 5. Modified Medical Research Council (mMRC) dyspnea rating of at least 2 out of 5. Exclusion Criteria: 1. Disease severity or co-morbidity that would make the patient be at-risk for participation this study 2. A significant movement disorder, such as hemiplegia, etc. 3. Inability to read and comprehend the questionnaires, which will be in English 4. 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).


Study is Available At:


Original ID:

14-06-001 E


NCT ID:

NCT02399254


Secondary ID:


Study Acronym:


Brief Title:

The Trajectory of Physical Activity Following Pulmonary Rehabilitation


Official Title:

The Trajectory of Physical Activity Following Pulmonary Rehabilitation


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

40 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Saint Francis Care


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

21


Enrollment Type:

Actual


Overall Contact Information

Official Name:Richard ZuWallack, MD
Principal Investigator
Saint Francis Hospital and Medical Center

Study Dates

Start Date:April 2015
Completion Date:June 15, 2017
Completion Type:Actual
Primary Completion Date:June 15, 2017
Primary Completion Type:Actual
Verification Date:April 2019
Last Changed Date:July 29, 2019
First Received Date:March 16, 2015
First Results Date:June 12, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Activity-related Energy Expenditure (AEE)(J/Min/kg) at 48 Weeks
Time Frame:48 weeks compared to baseline
Safety Issues:False
Description:Investigators will look at changes in activity-related energy expenditure (from the DynaPort) at 48 weeks compared to baseline
Outcome Type:Secondary Outcome
Measure:Activity-related Energy Expenditure (AEE)(J/Min/kg) at 12 Weeks
Time Frame:12 weeks compared to baseline
Safety Issues:False
Description:Investigators will look at changes in activity-related energy expenditure (from the DynaPort) at 12 weeks compared to baseline
Outcome Type:Primary Outcome
Measure:Minutes/Day at 48 Weeks
Time Frame:48 weeks compared to baseline
Safety Issues:False
Description: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.
Outcome Type:Primary Outcome
Measure:Minutes/Day at 12 Weeks
Time Frame:12 weeks compared to baseline
Safety Issues:False
Description: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.

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:Pulmonary Rehabilitation
Description:Chronic Obstructive Pulmonary Disease (COPD) patients following pulmonary rehabilitation

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Saint Francis Care

Samples and Retentions

Study Population: Pulmonary Rehabilitation Center
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.