Rehabilitation of Idiopathic Pulmonary Fibrosis (IPF) Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01118221
First received: April 27, 2010
Last updated: February 13, 2015
Last verified: February 2015
Results First Received: November 19, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Idiopathic Pulmonary Fibrosis
Intervention: Behavioral: pulmonary rehabilitation

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Pulmonary Rehabilitation

enroll in pulmonary rehabilitation program

pulmonary rehabilitation: structured exercise program

Control no structured exercise

Participant Flow:   Overall Study
    Pulmonary Rehabilitation     Control  
STARTED     14     11  
COMPLETED     11     10  
NOT COMPLETED     3     1  



  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.
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Reporting Groups
  Description
Pulmonary Rehabilitation

enroll in pulmonary rehabilitation program

pulmonary rehabilitation: structured exercise program

Control no structured exercise
Total Total of all reporting groups

Baseline Measures
    Pulmonary Rehabilitation     Control     Total  
Number of Participants  
[units: participants]
  14     11     25  
Age  
[units: years]
Mean ± Standard Deviation
  71  ± 6     66  ± 7     69  ± 6  
Gender  
[units: participants]
     
Female     2     2     4  
Male     12     9     21  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     6     6     12  
Not Hispanic or Latino     8     5     13  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     1     0     1  
White     13     11     24  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     14     10     24  
South America     0     1     1  



  Outcome Measures
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1.  Primary:   6 Minute Walk Distance   [ Time Frame: The 6-MWD will be measured at 0 and 3 months. ]

2.  Secondary:   Systemic Markers of Oxidant Stress   [ Time Frame: Markers of oxidant stress will be measured in all subjects before randomization after exercise testing at 0 months. ]

3.  Secondary:   Maximum Oxygen Uptake   [ Time Frame: Maximum O2 uptake will be measured at 0 and 3 months. ]


  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: Robert M Jackson, MD
Organization: MVAHS
phone: 305-575-3548
e-mail: robert.jackson4@va.gov


Publications of Results:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01118221     History of Changes
Other Study ID Numbers: O7467-R
Study First Received: April 27, 2010
Results First Received: November 19, 2014
Last Updated: February 13, 2015
Health Authority: United States: Federal Government