The Trajectory of Physical Activity Following Pulmonary Rehabilitation

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 Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive; COPD

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 Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06105
      • Saint Francis Hospital and Medical Center
    • Wallingford, Connecticut, United States, 06492
      • Gaylord Hospital
    • West Haven, Connecticut, United States, 06516
      • VA Connecticut Research and Education Foundation
  • Rhode Island
    • Providence, Rhode Island, United States, 02908
      • Ocean State Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pulmonary Rehabilitation Center

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pulmonary Rehabilitation; Chronic Obstructive Pulmonary Disease (COPD) patients following pulmonary rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Saint Francis Care
• Investigators: Principal Investigator: Richard ZuWallack, MD, Saint Francis Hospital and Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): June 15, 2017
• Study Completion (Actual): June 15, 2017

Study Registration Dates

• First Submitted: March 16, 2015
• First Submitted That Met QC Criteria: March 20, 2015
• First Posted (Estimate): March 26, 2015

Study Record Updates

• Last Update Posted (Actual): August 6, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Pulmonary Rehabilitation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 14-06-001 E