Clinical Trial: Exercise Training at Ambulatory Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis Patients

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

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 me

    Detailed Summary:
    Sponsor: Rabin Medical Center

    Current Primary Outcome:

    • Peak VO2 [ Time Frame: Before and after 12 weeks of Pulmonary Rehabilitation ]
      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 ]
      distance covered in meters during 6 min of walking


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Echocardiography Parameters [ Time Frame: Before and after 12 weeks of Pulmonary Rehabilitation ]
      Stroke Volume, Cardiac Output, Pulmonary Arterial Systolic Pressure
    • Blood tests [ Time Frame: Before and after 12 weeks of Pulmonary Rehabilitation ]
      NT-proBNP, CRP
    • Medical Research Council (MRC) dyspnea score questionnaire [ Time Frame: Before and after 12 weeks of Pulmonary Rehabilitation ]
    • St George's Respiratory Questionnaire (SGRQ) for evaluation quality of life [ Time Frame: Before and after 12 weeks of Pulmonary Rehabilitation ]
    • International Physical Activity Questionnaire (IPAQ)- for estimation physical activity level [ Time Frame: Before and after 12 weeks of Pulmonary Rehabilitation ]
    • Battery of 4 functional tests [ Time Frame: Before and after 12 weeks of Pulmonary Rehabilitation ]
      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 ]
      FVC, FEV1, FEV1\FVC, TLC, DLCO, FRC.


    Original Secondary Outcome: Same as current

    Information By: Rabin Medical Center

    Dates:
    Date Received: December 20, 2011
    Date Started: January 2012
    Date Completion: December 2013
    Last Updated: December 22, 2011
    Last Verified: December 2011