Exercise Training at Ambulatory Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Rabin Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Mordechai Kremer, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01499745
First received: December 20, 2011
Last updated: December 22, 2011
Last verified: December 2011
  Purpose
  • 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.

Condition Intervention
Idiopathic Pulmonary Fibrosis
Behavioral: Pulmonary Rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exercise Training at Ambulatory Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis Patients

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Peak VO2 [ Time Frame: Before and after 12 weeks of Pulmonary Rehabilitation ] [ Designated as safety issue: No ]
    Peak oxygen consumption during standart cardiopulmonary exercise test on bicycle argometer

  • 6 min walk test [ Time Frame: Before and after 12 weeks of Pulmonary Rehabilitation ] [ Designated as safety issue: No ]
    distance covered in meters during 6 min of walking


Secondary Outcome Measures:
  • Echocardiography Parameters [ Time Frame: Before and after 12 weeks of Pulmonary Rehabilitation ] [ Designated as safety issue: No ]
    Stroke Volume, Cardiac Output, Pulmonary Arterial Systolic Pressure

  • Blood tests [ Time Frame: Before and after 12 weeks of Pulmonary Rehabilitation ] [ Designated as safety issue: No ]
    NT-proBNP, CRP

  • Medical Research Council (MRC) dyspnea score questionnaire [ Time Frame: Before and after 12 weeks of Pulmonary Rehabilitation ] [ Designated as safety issue: No ]
  • St George's Respiratory Questionnaire (SGRQ) for evaluation quality of life [ Time Frame: Before and after 12 weeks of Pulmonary Rehabilitation ] [ Designated as safety issue: No ]
  • International Physical Activity Questionnaire (IPAQ)- for estimation physical activity level [ Time Frame: Before and after 12 weeks of Pulmonary Rehabilitation ] [ Designated as safety issue: No ]
  • Battery of 4 functional tests [ Time Frame: Before and after 12 weeks of Pulmonary Rehabilitation ] [ Designated as safety issue: No ]
    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

  • Pulmonary function test [ Time Frame: Before and after 12 weeks of Pulmonary Rehabilitation ] [ Designated as safety issue: No ]
    FVC, FEV1, FEV1\FVC, TLC, DLCO, FRC.


Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Exercise Training at Pulmonary Rehabilitation Program
Exercise Training at Pulmonary Rehabilitation Program 2 weekly sessions of 60 min for 12 weeks
Behavioral: Pulmonary Rehabilitation

Exercise Training in Pulmonary Rehabilitation Program:

12 weeks of 60 min exercise bout, twice a week at pulmonary rehabilitation

Placebo Comparator: Standard Treatment for IPF
Continue for normal live with standard treatment
Behavioral: Pulmonary Rehabilitation

Exercise Training in Pulmonary Rehabilitation Program:

12 weeks of 60 min exercise bout, twice a week at pulmonary rehabilitation


  Eligibility

Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01499745

Contacts
Contact: Baruch Vainshelboim, M.P.E. 972-39377221 Baruch.v1981@gmail.com

Locations
Israel
Pulmonary Institute, Rabin Medical Center, Beilinson Hospital Not yet recruiting
Petach Tikva, Israel
Contact: Baruch Vainshelboim, M.P.E.    972-39377221    Baruch.v1981@gmail.com   
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Mordechai R Kramer, M.D Rabin Medical Center, Belinson Hospital
  More Information

No publications provided

Responsible Party: Mordechai Kremer, Prof. Mordechai Kremer Head of Pulmonary Institute, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01499745     History of Changes
Other Study ID Numbers: RMCBH116531 CTIL
Study First Received: December 20, 2011
Last Updated: December 22, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
Idiopathic pulmonary fibrosis (IPF) patients

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial

ClinicalTrials.gov processed this record on August 21, 2014