Exercise Training at Ambulatory Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis Patients

NCT01499745 | Unknown DMC

• 1 other identifier: RMCBH116531 CTIL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

• Idiopathic pulmonary fibrosis (IPF) is a chronic progressive, fibrosing parenchymal lung disease with unknown etiology. The prevalence of IPF is estimated between 2-29 cases per 100,000 in general population with median survival rates of 2-5 years from time of diagnosed.
• Dyspnea and chronic dry cough are the prominent symptoms in those patients which cause to impaired functional capacity and quality of life (QOL).
• Drug therapy usually is ineffective approach, what makes a call for an effective treatment.
• Pulmonary Rehabilitation (PR) had been founded as safe and effective treatment in increasing functional capacity, decrease symptoms and improve QOL mainly among Chronic Obstructive Pulmonary Disease (COPD). However, recently growing evidence also supports the efficiency of PR in IPF patients.
• The Aim of the suggested study is to examine the effect of exercise training (ET) at ambulatory pulmonary rehabilitation among IPF patients.
• The investigators hypothesize that ET at PR program will increase functional capacity, will decrease level of dyspnea and improve QOL in IPF patients.
• Patients and Methods:
• 40 IPF patients males and females (aged 30-90 years old) will be recruiting to this study. After clinical assessment they will be randomly allocated to PR group n=20 or to Control group n=20.
• All patients will undergo a clinical assessment including medical history, risk factors for IPF and physical examination. On the first meeting at baseline and within one week post intervention (PR) the following measurements will be made: dyspnea score, QOL and physical activity level questionnaires. In addition, anthropometric measurements, echocardiography, blood samples, pulmonary function tests, cardiopulmonary exercise test, battery of functional test and 6 minute walk test (6MWT).
• The PR group will participate in 12 weeks of supervised group's ET program. The training program will be consisted two 6 week blocks of 60 min exercise bout twice a week. In the first block the patients will perform aerobic interval training with treadmill walking, cycling, and step climbing. In the second block, subjects will perform longer periods of continuous aerobic exercise, with resistance training by step climbing, unsupported arm/leg exercises with and without dumbbells (0.5-1 kg), and supporting body weight over a chair. Pulmonary function test and 6MWT will be also performed after completing first 6 week block. The control group will be assessed at baseline and after 12 weeks without participating in PR program.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic pulmonary fibrosis (IPF) patients

Outcome Measures

Primary Outcomes (2)

• Peak VO2

  Peak oxygen consumption during standart cardiopulmonary exercise test on bicycle argometer

  Before and after 12 weeks of Pulmonary Rehabilitation

• 6 min walk test

  distance covered in meters during 6 min of walking

  Before and after 12 weeks of Pulmonary Rehabilitation

Secondary Outcomes (7)

• Echocardiography Parameters

  Before and after 12 weeks of Pulmonary Rehabilitation

• Blood tests

  Before and after 12 weeks of Pulmonary Rehabilitation

• Medical Research Council (MRC) dyspnea score questionnaire

  Before and after 12 weeks of Pulmonary Rehabilitation

• St George's Respiratory Questionnaire (SGRQ) for evaluation quality of life

  Before and after 12 weeks of Pulmonary Rehabilitation

• International Physical Activity Questionnaire (IPAQ)- for estimation physical activity level

  Before and after 12 weeks of Pulmonary Rehabilitation

Study Arms (2)

Exercise Training at Pulmonary Rehabilitation Program

ACTIVE COMPARATOR

Exercise Training at Pulmonary Rehabilitation Program 2 weekly sessions of 60 min for 12 weeks

Behavioral: Pulmonary Rehabilitation

Standard Treatment for IPF

PLACEBO COMPARATOR

Continue for normal live with standard treatment

Behavioral: Pulmonary Rehabilitation

Interventions

Pulmonary Rehabilitation BEHAVIORAL

Exercise Training in Pulmonary Rehabilitation Program: 12 weeks of 60 min exercise bout, twice a week at pulmonary rehabilitation

Exercise Training at Pulmonary Rehabilitation Program; Standard Treatment for IPF

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• IPF patients diagnosed essentially according to the American Thoracic and European Respiratory Societies (ATS-ERS) by clinical diagnostic criteria of:
• High-resolution computed tomography (HRCT) demonstrating a pattern of "confident" or "possible" IPF (b) Abnormal pulmonary physiology with evidence of restriction and/or impaired gas exchange (can exist during exercise alone)

You may not qualify if:

• Patients with severe comorbid illnesses, unstable coronary artery disease, collagen vascular diseases and the need for high flow oxygen therapy (˃ 3-4 L\\min).
• History of syncope on exertion or any comorbidities which precluded exercise training (such as severe orthopaedic or neurological deficits or unstable cardiac disease).
• Patients were also excluded if they had participated in a pulmonary rehabilitation program in the past 12 months.

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Pulmonary Institute, Rabin Medical Center, Beilinson Hospital

Petah Tikva, Israel

Location

Related Publications (4)

• Vainshelboim B, Kramer MR, Myers J, Unterman A, Izhakian S, Oliveira J. 8-Foot-Up-and-Go Test is Associated with Hospitalizations and Mortality in Idiopathic Pulmonary Fibrosis: A Prospective Pilot Study. Lung. 2019 Feb;197(1):81-88. doi: 10.1007/s00408-018-0189-4. Epub 2019 Jan 2.

  PMID: 30600393 DERIVED

• Vainshelboim B, Oliveira J, Fox BD, Kramer MR. The Prognostic Role of Ventilatory Inefficiency and Exercise Capacity in Idiopathic Pulmonary Fibrosis. Respir Care. 2016 Aug;61(8):1100-9. doi: 10.4187/respcare.04471. Epub 2016 May 10.

  PMID: 27165419 DERIVED

• Vainshelboim B, Fox BD, Kramer MR, Izhakian S, Gershman E, Oliveira J. Short-Term Improvement in Physical Activity and Body Composition After Supervised Exercise Training Program in Idiopathic Pulmonary Fibrosis. Arch Phys Med Rehabil. 2016 May;97(5):788-97. doi: 10.1016/j.apmr.2016.01.018. Epub 2016 Feb 8.

  PMID: 26869288 DERIVED

• Vainshelboim B, Oliveira J, Fox BD, Soreck Y, Fruchter O, Kramer MR. Long-term effects of a 12-week exercise training program on clinical outcomes in idiopathic pulmonary fibrosis. Lung. 2015 Jun;193(3):345-54. doi: 10.1007/s00408-015-9703-0. Epub 2015 Mar 3.

  PMID: 25731736 DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Mordechai R Kramer, M.D

  Rabin Medical Center, Belinson Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Baruch Vainshelboim, M.P.E.

CONTACT

972-39377221; Baruch.v1981@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Mordechai Kremer Head of Pulmonary Institute

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: December 26, 2011
• Study Start: January 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 26, 2011

Record last verified: 2011-12

Locations

IL (1)