The Trajectory of Physical Activity Following Pulmonary Rehabilitation

NCT02399254 | Completed Results

• 1 other identifier: 14-06-001 E
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 4

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.

Conditions

COPD; Pulmonary Disease, Chronic Obstructive

Keywords

Pulmonary Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Activity-related Energy Expenditure (AEE)(J/Min/kg) at 12 Weeks

  12 weeks compared to baseline

• Activity-related Energy Expenditure (AEE)(J/Min/kg) at 48 Weeks

  48 weeks compared to baseline

Study Arms (1)

Pulmonary Rehabilitation

Chronic Obstructive Pulmonary Disease (COPD) patients following pulmonary rehabilitation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pulmonary Rehabilitation Center

You may qualify if:

• Adults (≥ 40 years) with a primary clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
• 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)
• The patient was referred to pulmonary rehabilitation
• The patient is clinically-stable: no exacerbation in preceding 4 weeks
• Modified Medical Research Council (mMRC) dyspnea rating of at least 2 out of 5.

You may not qualify if:

• Disease severity or co-morbidity that would make the patient be at-risk for participation this study
• A significant movement disorder, such as hemiplegia, etc.
• Inability to read and comprehend the questionnaires, which will be in English

Sponsors & Collaborators

• Trinity Health Of New England: lead

Study Sites (4)

Saint Francis Hospital and Medical Center

Hartford, Connecticut, 06105, United States

Location

Gaylord Hospital

Wallingford, Connecticut, 06492, United States

Location

VA Connecticut Research and Education Foundation

West Haven, Connecticut, 06516, United States

Location

Ocean State Research Institute

Providence, Rhode Island, 02908, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Richard ZuWallack, MD
• Organization: Saint Francis Hospital and Medical Center

RZuWalla@TrinityHealthOfNE.org

860-714-4055

Study Officials

• Richard ZuWallack, MD

  Saint Francis Hospital and Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: March 26, 2015
• Study Start: April 1, 2015
• Primary Completion: June 15, 2017
• Study Completion: June 15, 2017
• Last Updated: August 6, 2019
• Results First Posted: July 8, 2019

Record last verified: 2019-04

Locations

US (4)