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Innovation in Pulmonary Rehabilitation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00123422
First Posted: July 22, 2005
Last Update Posted: October 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
Results First Submitted: October 2, 2014  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Breathing Retraining   Heliox   Exercise
STARTED   35   33   35 
8-week Testing   32   30   27 
COMPLETED   31   27   25 
NOT COMPLETED   4   6   10 
Physician Decision                2                2                6 
Withdrawal by Subject                1                2                2 
Lost to Follow-up                1                2                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
   Breathing Retraining   Heliox   Exercise   Total 
Overall Participants Analyzed 
[Units: Participants]
 35   33   35   103 
Age 
[Units: Years]
Mean (Standard Deviation)
 68  (10)   70  (9)   69  (7)   69  (9) 
Gender 
[Units: Participants]
       
Female   2   2   1   5 
Male   33   31   34   98 
Region of Enrollment 
[Units: Participants]
       
United States   35   33   35   103 
Smoking history [1] 
[Units: Pack/years]
Mean (Standard Deviation)
 62  (37)   67  (40)   68  (48)   64  (42) 
[1] 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] 
[Units: Percent]
Mean (Standard Deviation)
 45  (14)   46  (14)   41  (13)   44  (14) 
[1] 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] 
[Units: Percent]
Mean (Standard Deviation)
 165  (27)   158  (24)   161  (24)   161  (25) 
[1] 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.


  Outcome Measures
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1.  Primary:   Exercise Endurance   [ Time Frame: 14 weeks ]

2.  Secondary:   Inspiratory Capacity   [ Time Frame: 14 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: eileen.collins@va.gov


Publications of Results:

Responsible Party: VA Office of Research and Development
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