The Trajectory of Physical Activity Following Pulmonary Rehabilitation

COPD Clinical Trial

Official title:

The Trajectory of Physical Activity Following Pulmonary Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02399254
• Other study ID #: 14-06-001 E
• Status: Completed
• Start date: April 2015
• Est. completion date: June 15, 2017

Study information

• Verified date: April 2019
• Source: Saint Francis Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 15, 2017
• Est. primary completion date: June 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Disease
• COPD
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
United States	Saint Francis Hospital and Medical Center	Hartford	Connecticut
United States	Ocean State Research Institute	Providence	Rhode Island
United States	Gaylord Hospital	Wallingford	Connecticut
United States	VA Connecticut Research and Education Foundation	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Saint Francis Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks compared to baseline
Primary	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.	48 weeks compared to baseline
Secondary	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	12 weeks compared to baseline
Secondary	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	48 weeks compared to baseline