N/A
N=21
The Trajectory of Physical Activity Following Pulmonary Rehabilitation
COPD · Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT02399254 ↗Enrolled (actual)
21
Serious AEs
47.6%
Results posted
Jul 2019
Primary outcome: Primary: Minutes/Day at 12 Weeks — 1.3125000 minutes/day
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Trinity Health Of New England
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Minutes/Day at 12 Weeks |
1.3125000 | — |
| PRIMARY Minutes/Day at 48 Weeks |
0.5000000 | — |
| SECONDARY Activity-related Energy Expenditure (AEE)(J/Min/kg) at 12 Weeks |
4.9375000 | — |
| SECONDARY Activity-related Energy Expenditure (AEE)(J/Min/kg) at 48 Weeks |
2.9000000 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
- 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).
Data sourced from ClinicalTrials.gov (NCT02399254). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.