Exercise Training at Ambulatory Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis Patients

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

Exercise Training at Ambulatory Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01499745
• Other study ID #: RMCBH116531 CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: December 20, 2011
• Last updated: December 22, 2011
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: December 2011
• Source: Rabin Medical Center
• Contact: Baruch Vainshelboim, M.P.E.
• Phone: 972-39377221
• Email: Baruch.v1981[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

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

Locations

Country	Name	City	State
Israel	Pulmonary Institute, Rabin Medical Center, Beilinson Hospital	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak VO2	Peak oxygen consumption during standart cardiopulmonary exercise test on bicycle argometer	Before and after 12 weeks of Pulmonary Rehabilitation	No
Primary	6 min walk test	distance covered in meters during 6 min of walking	Before and after 12 weeks of Pulmonary Rehabilitation	No
Secondary	Echocardiography Parameters	Stroke Volume, Cardiac Output, Pulmonary Arterial Systolic Pressure	Before and after 12 weeks of Pulmonary Rehabilitation	No
Secondary	Blood tests	NT-proBNP, CRP	Before and after 12 weeks of Pulmonary Rehabilitation	No
Secondary	Medical Research Council (MRC) dyspnea score questionnaire		Before and after 12 weeks of Pulmonary Rehabilitation	No
Secondary	St George's Respiratory Questionnaire (SGRQ) for evaluation quality of life		Before and after 12 weeks of Pulmonary Rehabilitation	No
Secondary	International Physical Activity Questionnaire (IPAQ)- for estimation physical activity level		Before and after 12 weeks of Pulmonary Rehabilitation	No
Secondary	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	No
Secondary	Pulmonary function test	FVC, FEV1, FEV1\FVC, TLC, DLCO, FRC.	Before and after 12 weeks of Pulmonary Rehabilitation	No