COPD, Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Pulmonary Rehabilitation
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.
Interventions
None listed
Sponsors
Trinity Health Of New England
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minutes/Day at 12 Weeks | 12 weeks compared to baseline | 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. |
| Minutes/Day at 48 Weeks | 48 weeks compared to baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Activity-related Energy Expenditure (AEE)(J/Min/kg) at 12 Weeks | 12 weeks compared to baseline | Investigators will look at changes in activity-related energy expenditure (from the DynaPort) at 12 weeks compared to baseline |
| Activity-related Energy Expenditure (AEE)(J/Min/kg) at 48 Weeks | 48 weeks compared to baseline | Investigators will look at changes in activity-related energy expenditure (from the DynaPort) at 48 weeks compared to baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pulmonary Rehabilitation COPD patients following pulmonary rehabilitation | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 2 |
Baseline characteristics
| Characteristic | Pulmonary Rehabilitation | — |
|---|---|---|
| Age, Continuous | 67.2 years STANDARD_DEVIATION 7.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 21 participants | — |
| Sex: Female, Male Female | 4 Participants | — |
| Sex: Female, Male Male | 17 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 10 / 21 |
Outcome results
Primary
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.
Time frame: 12 weeks compared to baseline
Population: Obtaining valid activity data (uploaded to the manufacturer then downloaded to the site) was a problem at all sites despite good support from the manufacturer. As a result a N of 16 could be analyzed at week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmonary Rehabilitation | Minutes/Day at 12 Weeks | 1.3125000 minutes/day | Standard Error 0.740038 |
Primary
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.
Time frame: 48 weeks compared to baseline
Population: Obtaining valid activity data (uploaded to the manufacturer then downloaded to the site) was a problem at all sites despite good support from the manufacturer. As a result a N of 10 could be analyzed at week 48.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmonary Rehabilitation | Minutes/Day at 48 Weeks | 0.5000000 minutes/day | Standard Error 1.0979779 |
Secondary
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
Time frame: 12 weeks compared to baseline
Population: Obtaining valid activity data (uploaded to the manufacturer then downloaded to the site) was a problem at all sites despite good support from the manufacturer. As a result a N of 16 could be analyzed at week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmonary Rehabilitation | Activity-related Energy Expenditure (AEE)(J/Min/kg) at 12 Weeks | 4.9375000 AEE (J/min/kg) | Standard Error 1.9737206 |
Secondary
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
Time frame: 48 weeks compared to baseline
Population: Obtaining valid activity data (uploaded to the manufacturer then downloaded to the site) was a problem at all sites despite good support from the manufacturer. As a result a N of 10 could be analyzed at week 48.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmonary Rehabilitation | Activity-related Energy Expenditure (AEE)(J/Min/kg) at 48 Weeks | 2.9000000 AEE (J/min/kg) | Standard Error 1.9405039 |