Exercise Training at Ambulatory Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis Patients

Study Overview
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Brief Summary
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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.

Official Title
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Exercise Training at Ambulatory Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis Patients

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Behavioral: Pulmonary Rehabilitation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exercise Training at Pulmonary Rehabilitation Program<br>Exercise Training at Pulmonary Rehabilitation Program 2 weekly sessions of 60 min for 12 weeks | Behavioral: Pulmonary Rehabilitation<br>* Exercise Training in Pulmonary Rehabilitation Program: 12 weeks of 60 min exercise bout, twice a week at pulmonary rehabilitation<br>|
| Placebo Comparator: Standard Treatment for IPF<br>Continue for normal live with standard treatment | Behavioral: Pulmonary Rehabilitation<br>* Exercise Training in Pulmonary Rehabilitation Program: 12 weeks of 60 min exercise bout, twice a week at pulmonary rehabilitation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echocardiography Parameters | Stroke Volume, Cardiac Output, Pulmonary Arterial Systolic Pressure | Before and after 12 weeks of Pulmonary Rehabilitation | 
| Blood tests | NT-proBNP, CRP | 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 | 
| Battery of 4 functional tests | 1.30 seconds chair stand test- number of repetitions in 30 sec 2.Chair sit-and- reach test (trunk and hamstring flexibility) - number of cm on ruler 3.Back stretch (shoulder and back flexibility) - number of cm on ruler 4.8-ft-up-and -go (agility and coordination)- number of sec that takes to complete the task | Before and after 12 weeks of Pulmonary Rehabilitation | 
| Pulmonary function test | FVC, FEV1, FEV1\FVC, TLC, DLCO, FRC. | Before and after 12 weeks of Pulmonary Rehabilitation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Idiopathic pulmonary fibrosis (IPF) patients