Trial Outcomes & Findings for Innovation in Pulmonary Rehabilitation (NCT NCT00123422)

NCT ID: NCT00123422

Last Updated: 2014-10-16

Results Overview

Exercise endurance on a constant workrate treadmill test was measured at 14 weeks. The workload on the constant workrate treadmill test corresponded to the grade and speed that the participate had reached on a symptom-limited treadmill test when they reached 85% of their peak oxygen uptake value.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 103 participants
• Primary outcome timeframe: 14 weeks
• Results posted on: 2014-10-16

Participant Flow

192 patients were screened for eligibility in the study. 103 patients were randomly assigned to the one of the 3 groups. Patients were not randomized for the following reasons: PFT did not qualify (n=47), cardiac problems (n=13), changed mind (n=9), non-compliant (n=6), time constraints (n=5), too debilitated (n=3), other (n=6).

Participant milestones

Measure	Breathing Retraining Exercise training with computerized training program Breathing retraining: exercise training with computerized training program	Heliox Exercise training with helium oxygen combination Heliox: exercise training with a helium oxygen combination	Exercise Exercise training Exercise: exercise training
Overall Study STARTED	35	33	35
Overall Study 8-week Testing	32	30	27
Overall Study COMPLETED	31	27	25
Overall Study NOT COMPLETED	4	6	10

Reasons for withdrawal

Measure	Breathing Retraining Exercise training with computerized training program Breathing retraining: exercise training with computerized training program	Heliox Exercise training with helium oxygen combination Heliox: exercise training with a helium oxygen combination	Exercise Exercise training Exercise: exercise training
Overall Study Physician Decision	2	2	6
Overall Study Withdrawal by Subject	1	2	2
Overall Study Lost to Follow-up	1	2	2

Baseline Characteristics

Innovation in Pulmonary Rehabilitation

Baseline characteristics by cohort

Measure	Breathing Retraining n=35 Participants Exercise training with computerized training program Breathing retraining: exercise training with computerized training program	Heliox n=33 Participants Exercise training with helium oxygen combination Heliox: exercise training with a helium oxygen combination	Exercise n=35 Participants Exercise training Exercise: exercise training	Total n=103 Participants Total of all reporting groups
Age, Continuous	68 years STANDARD_DEVIATION 10 • n=5 Participants	70 years STANDARD_DEVIATION 9 • n=7 Participants	69 years STANDARD_DEVIATION 7 • n=5 Participants	69 years STANDARD_DEVIATION 9 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	31 Participants n=7 Participants	34 Participants n=5 Participants	98 Participants n=4 Participants
Region of Enrollment United States	35 participants n=5 Participants	33 participants n=7 Participants	35 participants n=5 Participants	103 participants n=4 Participants
Smoking history	62 pack/years STANDARD_DEVIATION 37 • n=5 Participants	67 pack/years STANDARD_DEVIATION 40 • n=7 Participants	68 pack/years STANDARD_DEVIATION 48 • n=5 Participants	64 pack/years STANDARD_DEVIATION 42 • n=4 Participants
FEV1 percent predicted	45 percent STANDARD_DEVIATION 14 • n=5 Participants	46 percent STANDARD_DEVIATION 14 • n=7 Participants	41 percent STANDARD_DEVIATION 13 • n=5 Participants	44 percent STANDARD_DEVIATION 14 • n=4 Participants
RV/TLC percent predicted	165 percent STANDARD_DEVIATION 27 • n=5 Participants	158 percent STANDARD_DEVIATION 24 • n=7 Participants	161 percent STANDARD_DEVIATION 24 • n=5 Participants	161 percent STANDARD_DEVIATION 25 • n=4 Participants

PRIMARY outcome

Timeframe: 14 weeks

Population: We used an intent-to treat analysis using the last value carried forward. All participants were included in the final analysis.

Exercise endurance on a constant workrate treadmill test was measured at 14 weeks. The workload on the constant workrate treadmill test corresponded to the grade and speed that the participate had reached on a symptom-limited treadmill test when they reached 85% of their peak oxygen uptake value.

Outcome measures

Measure	Breathing Retraining n=35 Participants Exercise training with computerized training program Breathing retraining: exercise training with computerized training program	Heliox n=33 Participants Exercise training with helium oxygen combination Heliox: exercise training with a helium oxygen combination	Exercise n=35 Participants Exercise training Exercise: exercise training
Exercise Endurance	18.1 minutes Standard Deviation 13.4	14.5 minutes Standard Deviation 10.7	11.5 minutes Standard Deviation 7.0

SECONDARY outcome

Timeframe: 14 weeks

Population: Intent-to-treat analysis was used so data on all randomized patients were analyzed.

Inspiratory capacity measured during exercise is a measure of air-trapping (dynamic hyperinflation). Inspiratory capacity was measured at an isotime (same time) during the constant workrate treadmill test at baseline and 14 weeks.

Outcome measures

Measure	Breathing Retraining n=35 Participants Exercise training with computerized training program Breathing retraining: exercise training with computerized training program	Heliox n=33 Participants Exercise training with helium oxygen combination Heliox: exercise training with a helium oxygen combination	Exercise n=35 Participants Exercise training Exercise: exercise training
Inspiratory Capacity	2.4 Liters Standard Deviation 0.7	2.0 Liters Standard Deviation 0.6	2.1 Liters Standard Deviation 0.7

Adverse Events

Breathing Retraining

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Heliox

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Exercise

Serious events: 5 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Breathing Retraining n=35 participants at risk Exercise training with computerized training program Breathing retraining: exercise training with computerized training program	Heliox n=33 participants at risk Exercise training with helium oxygen combination Heliox: exercise training with a helium oxygen combination	Exercise n=35 participants at risk Exercise training Exercise: exercise training
Cardiac disorders Cardiac Event	2.9% 1/35 • Adverse events were collected during the time period that the patient was enrolled in the study. When the patient completed the study (after 14 week testing was completed), we stopped collecting adverse event information.	0.00% 0/33 • Adverse events were collected during the time period that the patient was enrolled in the study. When the patient completed the study (after 14 week testing was completed), we stopped collecting adverse event information.	8.6% 3/35 • Adverse events were collected during the time period that the patient was enrolled in the study. When the patient completed the study (after 14 week testing was completed), we stopped collecting adverse event information.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) lung cancer	0.00% 0/35 • Adverse events were collected during the time period that the patient was enrolled in the study. When the patient completed the study (after 14 week testing was completed), we stopped collecting adverse event information.	0.00% 0/33 • Adverse events were collected during the time period that the patient was enrolled in the study. When the patient completed the study (after 14 week testing was completed), we stopped collecting adverse event information.	2.9% 1/35 • Number of events 1 • Adverse events were collected during the time period that the patient was enrolled in the study. When the patient completed the study (after 14 week testing was completed), we stopped collecting adverse event information.
Blood and lymphatic system disorders intracerebral bleed	0.00% 0/35 • Adverse events were collected during the time period that the patient was enrolled in the study. When the patient completed the study (after 14 week testing was completed), we stopped collecting adverse event information.	0.00% 0/33 • Adverse events were collected during the time period that the patient was enrolled in the study. When the patient completed the study (after 14 week testing was completed), we stopped collecting adverse event information.	2.9% 1/35 • Number of events 1 • Adverse events were collected during the time period that the patient was enrolled in the study. When the patient completed the study (after 14 week testing was completed), we stopped collecting adverse event information.

Other adverse events

Measure	Breathing Retraining n=35 participants at risk Exercise training with computerized training program Breathing retraining: exercise training with computerized training program	Heliox n=33 participants at risk Exercise training with helium oxygen combination Heliox: exercise training with a helium oxygen combination	Exercise n=35 participants at risk Exercise training Exercise: exercise training
Respiratory, thoracic and mediastinal disorders COPD exacerbation	0.00% 0/35 • Adverse events were collected during the time period that the patient was enrolled in the study. When the patient completed the study (after 14 week testing was completed), we stopped collecting adverse event information.	6.1% 2/33 • Number of events 2 • Adverse events were collected during the time period that the patient was enrolled in the study. When the patient completed the study (after 14 week testing was completed), we stopped collecting adverse event information.	2.9% 1/35 • Number of events 1 • Adverse events were collected during the time period that the patient was enrolled in the study. When the patient completed the study (after 14 week testing was completed), we stopped collecting adverse event information.
Blood and lymphatic system disorders cellulitis	2.9% 1/35 • Number of events 1 • Adverse events were collected during the time period that the patient was enrolled in the study. When the patient completed the study (after 14 week testing was completed), we stopped collecting adverse event information.	0.00% 0/33 • Adverse events were collected during the time period that the patient was enrolled in the study. When the patient completed the study (after 14 week testing was completed), we stopped collecting adverse event information.	0.00% 0/35 • Adverse events were collected during the time period that the patient was enrolled in the study. When the patient completed the study (after 14 week testing was completed), we stopped collecting adverse event information.

Additional Information

Eileen Collins

Edward Hines Jr. ,VA Hospital

Phone: 708-202-3525

Email: eileen.collins@va.gov

Results disclosure agreements

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