Trial Outcomes & Findings for The Trajectory of Physical Activity Following Pulmonary Rehabilitation (NCT NCT02399254)

NCT ID: NCT02399254

Last Updated: 2019-08-06

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 21 participants
• Primary outcome timeframe: 12 weeks compared to baseline
• Results posted on: 2019-08-06

Participant Flow

Participant milestones

Measure	Pulmonary Rehabilitation COPD patients following pulmonary rehabilitation
Overall Study STARTED	21
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Pulmonary Rehabilitation COPD patients following pulmonary rehabilitation
Overall Study Physician Decision	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Pulmonary Rehabilitation n=21 Participants COPD patients following pulmonary rehabilitation
Age, Continuous	67.2 years STANDARD_DEVIATION 7.6 • n=21 Participants
Sex: Female, Male Female	4 Participants n=21 Participants
Sex: Female, Male Male	17 Participants n=21 Participants
Region of Enrollment United States	21 participants n=21 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Pulmonary Rehabilitation n=16 Participants Chronic Obstructive Pulmonary Disease (COPD) patients following pulmonary rehabilitation
Minutes/Day at 12 Weeks	1.3125000 minutes/day Standard Error 0.7400380

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Pulmonary Rehabilitation n=10 Participants Chronic Obstructive Pulmonary Disease (COPD) patients following pulmonary rehabilitation
Minutes/Day at 48 Weeks	0.5000000 minutes/day Standard Error 1.0979779

SECONDARY outcome

Timeframe: 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.

Investigators will look at changes in activity-related energy expenditure (from the DynaPort) at 12 weeks compared to baseline

Outcome measures

Measure	Pulmonary Rehabilitation n=16 Participants Chronic Obstructive Pulmonary Disease (COPD) patients following pulmonary rehabilitation
Activity-related Energy Expenditure (AEE)(J/Min/kg) at 12 Weeks	4.9375000 AEE (J/min/kg) Standard Error 1.9737206

SECONDARY outcome

Timeframe: 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.

Investigators will look at changes in activity-related energy expenditure (from the DynaPort) at 48 weeks compared to baseline

Outcome measures

Measure	Pulmonary Rehabilitation n=10 Participants Chronic Obstructive Pulmonary Disease (COPD) patients following pulmonary rehabilitation
Activity-related Energy Expenditure (AEE)(J/Min/kg) at 48 Weeks	2.9000000 AEE (J/min/kg) Standard Error 1.9405039

Adverse Events

Pulmonary Rehabilitation

Serious events: 10 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pulmonary Rehabilitation n=21 participants at risk COPD patients following pulmonary rehabilitation
Respiratory, thoracic and mediastinal disorders COPD exacerbation	33.3% 7/21 • Number of events 9 • 48 Weeks Events reported by subjects at 12 week visit 24 week visit,36 week visit and 48 week visit
Gastrointestinal disorders Diarrhea	4.8% 1/21 • Number of events 1 • 48 Weeks Events reported by subjects at 12 week visit 24 week visit,36 week visit and 48 week visit
Infections and infestations Pneumonia	4.8% 1/21 • Number of events 1 • 48 Weeks Events reported by subjects at 12 week visit 24 week visit,36 week visit and 48 week visit
General disorders Cholelithiasis	4.8% 1/21 • Number of events 1 • 48 Weeks Events reported by subjects at 12 week visit 24 week visit,36 week visit and 48 week visit
Vascular disorders Deep Vein Thrombosis	4.8% 1/21 • Number of events 1 • 48 Weeks Events reported by subjects at 12 week visit 24 week visit,36 week visit and 48 week visit

Other adverse events

Adverse event data not reported

Additional Information

Richard ZuWallack, MD

Saint Francis Hospital and Medical Center

Phone: 860-714-4055

Email: RZuWalla@TrinityHealthOfNE.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place