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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary Rehabilitation | Chronic Obstructive Pulmonary Disease (COPD) patients following pulmonary rehabilitation |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Pulmonary Rehabilitation Center
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| Name | Affiliation | Role |
|---|---|---|
| Richard ZuWallack, MD | Saint Francis Hospital and Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Francis Hospital and Medical Center | Hartford | Connecticut | 06105 | United States | ||
| Gaylord Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pulmonary Rehabilitation | COPD patients following pulmonary rehabilitation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pulmonary Rehabilitation | COPD patients following pulmonary rehabilitation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Error | minutes/day | 12 weeks compared to baseline |
|
|
48 Weeks
Events reported by subjects at 12 week visit 24 week visit,36 week visit and 48 week visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pulmonary Rehabilitation | COPD patients following pulmonary rehabilitation | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COPD exacerbation | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment | Chronic obstructive pulmonary disease exacerbation,Shortness of breath |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard ZuWallack, MD | Saint Francis Hospital and Medical Center | 860-714-4055 | RZuWalla@TrinityHealthOfNE.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 7, 2015 | Apr 26, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Investigators will look at changes in activity-related energy expenditure (from the DynaPort) at 48 weeks compared to baseline |
| 48 weeks compared to baseline |
| Wallingford |
| Connecticut |
| 06492 |
| United States |
| VA Connecticut Research and Education Foundation | West Haven | Connecticut | 06516 | United States |
| Ocean State Research Institute | Providence | Rhode Island | 02908 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| 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. | 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. | Posted | Mean | Standard Error | minutes/day | 48 weeks compared to baseline |
|
|
|
| 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 | 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. | Posted | Mean | Standard Error | AEE (J/min/kg) | 12 weeks compared to baseline |
|
|
|
| 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 | 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. | Posted | Mean | Standard Error | AEE (J/min/kg) | 48 weeks compared to baseline |
|
|
|
| 21 |
| 10 |
| 21 |
| 0 |
| 21 |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment | Loose bowel, loose stools |
|
| Pneumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Cholelithiasis | General disorders | MedDRA (10.0) | Systematic Assessment | gallstones, gall bladder stones |
|
| Deep Vein Thrombosis | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |