Rehabilitation of Idiopathic Pulmonary Fibrosis (IPF) Patients

Study Description

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Brief Summary:

The incidence and prevalence of IPF increase exponentially with age, and IPF occurs more often in older males. Cigarette smoking and environmental dust exposures are known risk factors for developing IPF. For example, the recently deployed military population, as it ages, is at especially increased risk of IPF. No effective therapies exist, although lung transplantation is used to extend survival of selected patients.

Defining specific therapy to improve exercise tolerance and dyspnea in IPF patients is thus an urgent priority of veteran-oriented research programs.

Condition or disease	Intervention/treatment	Phase
Idiopathic Pulmonary Fibrosis	Behavioral: pulmonary rehabilitation	Not Applicable

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	25 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Rehabilitation of IPF Patients: Effects of Exercise and Oxidant Stress
Study Start Date :	October 2010
Actual Primary Completion Date :	September 2013
Actual Study Completion Date :	September 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Arm 1; enroll in pulmonary rehabilitation program	Behavioral: pulmonary rehabilitation; structured exercise program
No Intervention: Arm 2; no structured exercise

Outcome Measures

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Primary Outcome Measures :

1. 6 Minute Walk Distance [ Time Frame: The 6-MWD will be measured at 0 and 3 months. ]
   Change in 6 Minute Walk Distance from Baseline to 3 Months

Secondary Outcome Measures :

1. 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. ]
   Plasma F2-isoprostanes measured in all subjects before and after exercise testing at baseline.
2. Maximum Oxygen Uptake [ Time Frame: Maximum O2 uptake will be measured at 0 and 3 months. ]
   Change in 6 peak O2 uptake from Baseline to 3 Months

Eligibility Criteria

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Ages Eligible for Study:	40 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Clinical presentation consistent with IPF with onset between three months and 48 months prior to screening.
• Diagnosis made by high-resolution computed tomographic scan showing highly probable IPF.
• Absence of severe pulmonary hypertension (i.e., PAsys must be less than 55 mm Hg, based on echocardiography) and absence of decompensated right heart failure (NYHA class I or II acceptable).
• Age 40 through 80, inclusive.
• Abnormal pulmonary function tests (FVC 40-90% predicted or DLCO 30-90% predicted or impaired gas exchange with rest or exercise).
• Six-minute walk distance 150 m and 500 m.
• Worsening as demonstrated by any one of the following within the past year: > 10% decrease in percent predicted forced vital capacity or worsening dyspnea at rest or upon exertion, based on history.
• Ability to understand and sign a written informed consent form and comply with the requirements of the study.
• Absence of clinical features suggesting infection, neoplasm, sarcoidosis or collagen-vascular disease.

Exclusion Criteria:

• Echocardiographic evidence of severe pulmonary hypertension (PAsys>55 mm Hg, based on echocardiography or TR velocity 3.2 m/sec).
• Severe heart failure (NYHA class III or IV or LVEF < 45%).
• Six-minute walk distance < 150 m or > 500 m.
• FEV1/FVC ratio < 0.7 at screening (post-bronchodilator).
• Residual volume > 100% predicted.
• Any condition other than IPF likely to result in the death of the participant within the next two years.
• History of unstable or deteriorating cardiac or neurologic disease.
• Pregnancy or lactation. Patients who are: (a) pregnant or (b) breast feeding are excluded from the study.
• Current treatment with corticosteroids (either oral or inhaled), Cytoxan, azathioprine, colchicine, pirfenidone, anti-tumor necrosis factor therapy or endothelin receptor blockers. Prior treatment is permitted, but at least four weeks of treatment washout prior to inclusion in this study are required.
• Investigational therapy for any indication within 28 days prior to enrollment.
• Degenerative arthritis, cerebrovascular accident or other limitation to mobility preventing completion of the 6-minute walk test.
• Oxygen saturation on room air <80% at rest.

Contacts and Locations

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Locations

United States, Florida
VA Medical Center, Miami
Miami, Florida, United States, 33125

Sponsors and Collaborators

VA Office of Research and Development

Investigators

Principal Investigator:	Robert M Jackson, MD	VA Medical Center, Miami

More Information

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Publications of Results:

Jackson RM, Gómez-Marín OW, Ramos CF, Sol CM, Cohen MI, Gaunaurd IA, Cahalin LP, Cardenas DD. Exercise limitation in IPF patients: a randomized trial of pulmonary rehabilitation. Lung. 2014 Jun;192(3):367-76. doi: 10.1007/s00408-014-9566-9. Epub 2014 Apr 5.

Gaunaurd IA, Gómez-Marín OW, Ramos CF, Sol CM, Cohen MI, Cahalin LP, Cardenas DD, Jackson RM. Physical activity and quality of life improvements of patients with idiopathic pulmonary fibrosis completing a pulmonary rehabilitation program. Respir Care. 2014 Dec;59(12):1872-9. doi: 10.4187/respcare.03180. Epub 2014 Sep 2.

Responsible Party:	VA Office of Research and Development
ClinicalTrials.gov Identifier:	NCT01118221 History of Changes
Other Study ID Numbers:	O7467-R
First Posted:	May 6, 2010
Results First Posted:	January 16, 2015
Last Update Posted:	March 4, 2015
Last Verified:	February 2015

Keywords provided by VA Office of Research and Development:

oxidant stress; exercise

Additional relevant MeSH terms:

Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Idiopathic Interstitial Pneumonias	Pathologic Processes; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Interstitial