Clinical trial NCT02399254: The Trajectory of Physical Activity Following Pulmonary Rehabilitation
Official title: The Trajectory of Physical Activity Following Pulmonary Rehabilitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Pulmonary Disease, Chronic Obstructive
Keywords: Pulmonary Rehabilitation
Lead sponsor: Trinity Health Of New England
Sponsor class: OTHER
First posted: 2015-03-26
Enrollment: 21
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pulmonary Rehabilitation Center

Brief 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.

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.

Eligibility 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).

Primary outcomes:
measure: Minutes/Day at 12 Weeks
timeFrame: 12 weeks compared to baseline
measure: Minutes/Day at 48 Weeks
timeFrame: 48 weeks compared to baseline
Secondary outcomes:
measure: Activity-related Energy Expenditure (AEE)(J/Min/kg) at 12 Weeks
timeFrame: 12 weeks compared to baseline
measure: Activity-related Energy Expenditure (AEE)(J/Min/kg) at 48 Weeks
timeFrame: 48 weeks compared to baseline
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Saint Francis Hospital and Medical Center
state: Connecticut
city: Wallingford
country: United States
facility: Gaylord Hospital
state: Connecticut
city: West Haven
country: United States
facility: VA Connecticut Research and Education Foundation
state: Connecticut
city: Providence
country: United States
facility: Ocean State Research Institute
state: Rhode Island
Study officials:
affiliation: Saint Francis Hospital and Medical Center
name: Richard ZuWallack, MD
role: PRINCIPAL_INVESTIGATOR
References: