The Trajectory of Physical Activity Following Pulmonary Rehabilitation

NCT ID: NCT02399254

Last Updated: 2019-08-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 21 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-06-15

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.

Conditions

COPD; Pulmonary Disease, Chronic Obstructive

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pulmonary Rehabilitation

Chronic Obstructive Pulmonary Disease (COPD) patients following pulmonary rehabilitation

No interventions assigned to this group

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).

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Trinity Health Of New England

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard ZuWallack, MD

Role: PRINCIPAL_INVESTIGATOR

Saint Francis Hospital and Medical Center

Locations

Saint Francis Hospital and Medical Center

Hartford, Connecticut, United States

Gaylord Hospital

Wallingford, Connecticut, United States

VA Connecticut Research and Education Foundation

West Haven, Connecticut, United States

Ocean State Research Institute

Providence, Rhode Island, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

14-06-001 E

Identifier Type: -

Identifier Source: org_study_id