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Rehabilitation of Idiopathic Pulmonary Fibrosis (IPF) Patients

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.
ClinicalTrials.gov Identifier: NCT01118221
Recruitment Status : Completed
First Posted : May 6, 2010
Results First Posted : January 16, 2015
Last Update Posted : March 4, 2015
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Idiopathic Pulmonary Fibrosis
Intervention: Behavioral: pulmonary rehabilitation

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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

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
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 
Overall Participants Analyzed 
[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

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

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

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: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01118221     History of Changes
Other Study ID Numbers: O7467-R
First Submitted: April 27, 2010
First Posted: May 6, 2010
Results First Submitted: November 19, 2014
Results First Posted: January 16, 2015
Last Update Posted: March 4, 2015