Rehabilitation of Idiopathic Pulmonary Fibrosis (IPF) Patients

NCT01118221 | Completed Results DMC

• 1 other identifier: O7467-R
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

oxidant stress; exercise

Outcome Measures

Primary Outcomes (1)

• 6 Minute Walk Distance

  Change in 6 Minute Walk Distance from Baseline to 3 Months

  The 6-MWD will be measured at 0 and 3 months.

Secondary Outcomes (2)

• Systemic Markers of Oxidant Stress

  Markers of oxidant stress will be measured in all subjects before randomization after exercise testing at 0 months.

• Maximum Oxygen Uptake

  Maximum O2 uptake will be measured at 0 and 3 months.

Study Arms (2)

Arm 1

EXPERIMENTAL

enroll in pulmonary rehabilitation program

Behavioral: pulmonary rehabilitation

Arm 2

NO INTERVENTION

no structured exercise

Interventions

pulmonary rehabilitation BEHAVIORAL

structured exercise program

Arm 1

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Medical Center, Miami

Miami, Florida, 33125, United States

Location

Related Publications (2)

• Jackson RM, Gomez-Marin 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.

  PMID: 24705678 RESULT

• Gaunaurd IA, Gomez-Marin 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.

  PMID: 25185149 RESULT

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Motor Activity

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Behavior

Results Point of Contact

• Title: Robert M Jackson, MD
• Organization: MVAHS

robert.jackson4@va.gov

305-575-3548

Study Officials

• Robert M Jackson, MD

  VA Medical Center, Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2010
• First Posted: May 6, 2010
• Study Start: October 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: March 4, 2015
• Results First Posted: January 16, 2015

Record last verified: 2015-02

Locations

US (1)