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Innovation in Pulmonary Rehabilitation

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ClinicalTrials.gov Identifier: NCT00123422
Recruitment Status : Completed
First Posted : July 22, 2005
Results First Posted : October 7, 2014
Last Update Posted : October 16, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Pulmonary Disease
Pulmonary Emphysema
Interventions Behavioral: Breathing retraining
Behavioral: Heliox
Behavioral: Exercise
Enrollment 103
Recruitment Details 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).
Pre-assignment Details  
Arm/Group Title Breathing Retraining Heliox Exercise
Hide Arm/Group Description

Exercise training with computerized training program

Breathing retraining: exercise training with computerized training program

Exercise training with helium oxygen combination

Heliox: exercise training with a helium oxygen combination

Exercise training

Exercise: exercise training

Period Title: Overall Study
Started 35 33 35
8-week Testing 32 30 27
Completed 31 27 25
Not Completed 4 6 10
Reason Not Completed
Physician Decision             2             2             6
Withdrawal by Subject             1             2             2
Lost to Follow-up             1             2             2
Arm/Group Title Breathing Retraining Heliox Exercise Total
Hide Arm/Group Description

Exercise training with computerized training program

Breathing retraining: exercise training with computerized training program

Exercise training with helium oxygen combination

Heliox: exercise training with a helium oxygen combination

Exercise training

Exercise: exercise training

Total of all reporting groups
Overall Number of Baseline Participants 35 33 35 103
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 33 participants 35 participants 103 participants
68  (10) 70  (9) 69  (7) 69  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 33 participants 35 participants 103 participants
Female
2
   5.7%
2
   6.1%
1
   2.9%
5
   4.9%
Male
33
  94.3%
31
  93.9%
34
  97.1%
98
  95.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 35 participants 33 participants 35 participants 103 participants
35 33 35 103
Smoking history   [1] 
Mean (Standard Deviation)
Unit of measure:  Pack/years
Number Analyzed 35 participants 33 participants 35 participants 103 participants
62  (37) 67  (40) 68  (48) 64  (42)
[1]
Measure Description: Smoking history was measured in pack/years. This is the number of packs of cigarettes smoked per day multiplied by the number of years of smoking.
FEV1 percent predicted   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 35 participants 33 participants 35 participants 103 participants
45  (14) 46  (14) 41  (13) 44  (14)
[1]
Measure Description: The FEV1 (forced expiratory volume in 1 second) is a measure of pulmonary function. It is the amount of air that a person can blow out in one second. This value is reported as the percentage of predicted normal.
RV/TLC percent predicted   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 35 participants 33 participants 35 participants 103 participants
165  (27) 158  (24) 161  (24) 161  (25)
[1]
Measure Description: The RV/TLC (residual volume/total lung capacity) is a pulmonary function measure. It is an indication of air-trapping in the lungs. In general, a value over 120 percent predicted indicates that there is significant air-trapping.
1.Primary Outcome
Title Exercise Endurance
Hide Description 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.
Time Frame 14 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We used an intent-to treat analysis using the last value carried forward. All participants were included in the final analysis.
Arm/Group Title Breathing Retraining Heliox Exercise
Hide Arm/Group Description:

Exercise training with computerized training program

Breathing retraining: exercise training with computerized training program

Exercise training with helium oxygen combination

Heliox: exercise training with a helium oxygen combination

Exercise training

Exercise: exercise training

Overall Number of Participants Analyzed 35 33 35
Mean (Standard Deviation)
Unit of Measure: minutes
18.1  (13.4) 14.5  (10.7) 11.5  (7.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Breathing Retraining, Heliox, Exercise
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments Statistical tests were 2-sided and a p value of < 0.05 was the criterion for statistical significance.
Method ANCOVA
Comments The baseline value was the co-variate in this analysis.
2.Secondary Outcome
Title Inspiratory Capacity
Hide Description 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.
Time Frame 14 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis was used so data on all randomized patients were analyzed.
Arm/Group Title Breathing Retraining Heliox Exercise
Hide Arm/Group Description:

Exercise training with computerized training program

Breathing retraining: exercise training with computerized training program

Exercise training with helium oxygen combination

Heliox: exercise training with a helium oxygen combination

Exercise training

Exercise: exercise training

Overall Number of Participants Analyzed 35 33 35
Mean (Standard Deviation)
Unit of Measure: Liters
2.4  (0.7) 2.0  (0.6) 2.1  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Breathing Retraining, Heliox, Exercise
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANCOVA
Comments The baseline value was the co-variate in this analysis.
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Breathing Retraining Heliox Exercise
Hide Arm/Group Description

Exercise training with computerized training program

Breathing retraining: exercise training with computerized training program

Exercise training with helium oxygen combination

Heliox: exercise training with a helium oxygen combination

Exercise training

Exercise: exercise training

All-Cause Mortality
Breathing Retraining Heliox Exercise
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Breathing Retraining Heliox Exercise
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/35 (2.86%)      0/33 (0.00%)      5/35 (14.29%)    
Blood and lymphatic system disorders       
intracerebral bleed * [1]  0/35 (0.00%)  0 0/33 (0.00%)  0 1/35 (2.86%)  1
Cardiac disorders       
Cardiac Event * [2]  1/35 (2.86%)  0/33 (0.00%)  3/35 (8.57%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
lung cancer * [3]  0/35 (0.00%)  0 0/33 (0.00%)  0 1/35 (2.86%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Patient had a intercerebral bleed during the course of the study.
[2]
Patients had chest pain or needed an intervention such as angioplasty.
[3]
A patient developed lung cancer during the study.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Breathing Retraining Heliox Exercise
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/35 (2.86%)      2/33 (6.06%)      1/35 (2.86%)    
Blood and lymphatic system disorders       
cellulitis * [1]  1/35 (2.86%)  1 0/33 (0.00%)  0 0/35 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
COPD exacerbation * [2]  0/35 (0.00%)  0 2/33 (6.06%)  2 1/35 (2.86%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Patient developed a cellulitis in his legs
[2]
Exacerbation of COPD that lasted over 2 weeks and caused the patient to be withdrawn from the study.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Eileen Collins
Organization: Edward Hines Jr. ,VA Hospital
Phone: 708-202-3525
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00123422     History of Changes
Other Study ID Numbers: F3845-R
First Submitted: July 20, 2005
First Posted: July 22, 2005
Results First Submitted: October 2, 2014
Results First Posted: October 7, 2014
Last Update Posted: October 16, 2014