Clinical trial NCT01499745: Exercise Training at Ambulatory Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis Patients
Official title: Exercise Training at Ambulatory Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Idiopathic pulmonary fibrosis (IPF) patients
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2011-12-26
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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)
* Exclusion of other known causes of restrictive lung disease (e.g.: connective tissue disease, environmental exposure,etc

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Peak VO2
timeFrame: Before and after 12 weeks of Pulmonary Rehabilitation
measure: 6 min walk test
timeFrame: Before and after 12 weeks of Pulmonary Rehabilitation
Secondary outcomes:
measure: Echocardiography Parameters
timeFrame: Before and after 12 weeks of Pulmonary Rehabilitation
measure: Blood tests
timeFrame: Before and after 12 weeks of Pulmonary Rehabilitation
measure: Medical Research Council (MRC) dyspnea score questionnaire
timeFrame: Before and after 12 weeks of Pulmonary Rehabilitation
measure: St George's Respiratory Questionnaire (SGRQ) for evaluation quality of life
timeFrame: Before and after 12 weeks of Pulmonary Rehabilitation
measure: International Physical Activity Questionnaire (IPAQ)- for estimation physical activity level
timeFrame: Before and after 12 weeks of Pulmonary Rehabilitation
measure: Battery of 4 functional tests
timeFrame: Before and after 12 weeks of Pulmonary Rehabilitation
measure: Pulmonary function test
timeFrame: Before and after 12 weeks of Pulmonary Rehabilitation
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Pulmonary Institute, Rabin Medical Center, Beilinson Hospital
Study officials:
affiliation: Rabin Medical Center, Belinson Hospital
name: Mordechai R Kramer, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.