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Status unknownNCT01499745Updated Dec 26, 2011

Exercise Training at Ambulatory Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis Patients

An interventional study of Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis, sponsored by Rabin Medical Center. Status unknown at 1 site in Israel. Open to participants aged 30 Years to 90 Years. Per ClinicalTrials.gov, last updated 2011-12-26.

Sponsored by Rabin Medical Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2011), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
30 Years to 90 Years
Sex
All
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Study 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.
02

Conditions studied

  • Idiopathic Pulmonary Fibrosis

Keywords

  • Idiopathic pulmonary fibrosis (IPF) patients
03

In context

Idiopathic Pulmonary Fibrosis

565 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 117 are open to participants now.

This study's planned enrollment of 40 is below the median of 55 across 388 interventional studies indexed under Idiopathic Pulmonary Fibrosis.

Browse Idiopathic Pulmonary Fibrosis studies →

Lead sponsor

Rabin Medical Center is the lead sponsor of 393 studies on the registry; 30 are open to participants now.

Browse Rabin Medical Center studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • 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

  • Placebo comparator
    Standard Treatment for IPF

    Continue for normal live with standard treatment

    Behavioral: Pulmonary Rehabilitation

Interventions

  • BehavioralPulmonary Rehabilitation

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

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What researchers measure

Primary outcomes

  1. Peak VO2

    Peak oxygen consumption during standart cardiopulmonary exercise test on bicycle argometer

    Time frame: Before and after 12 weeks of Pulmonary Rehabilitation

  2. 6 min walk test

    distance covered in meters during 6 min of walking

    Time frame: Before and after 12 weeks of Pulmonary Rehabilitation

Secondary outcomes

  1. Echocardiography Parameters

    Stroke Volume, Cardiac Output, Pulmonary Arterial Systolic Pressure

    Time frame: Before and after 12 weeks of Pulmonary Rehabilitation

  2. Blood tests

    NT-proBNP, CRP

    Time frame: Before and after 12 weeks of Pulmonary Rehabilitation

  3. Medical Research Council (MRC) dyspnea score questionnaire

    Time frame: Before and after 12 weeks of Pulmonary Rehabilitation

  4. St George's Respiratory Questionnaire (SGRQ) for evaluation quality of life

    Time frame: Before and after 12 weeks of Pulmonary Rehabilitation

  5. International Physical Activity Questionnaire (IPAQ)- for estimation physical activity level

    Time frame: Before and after 12 weeks of Pulmonary Rehabilitation

  6. 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

    Time frame: Before and after 12 weeks of Pulmonary Rehabilitation

  7. Pulmonary function test

    FVC, FEV1, FEV1\\FVC, TLC, DLCO, FRC.

    Time frame: Before and after 12 weeks of Pulmonary Rehabilitation

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Study locations

1 site
  • Pulmonary Institute, Rabin Medical Center, Beilinson Hospital
    Petah Tikva, Israel
08

References and documents

Publications

  • 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. PubMed 30600393 ↗
  • 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. PubMed 27165419 ↗
  • 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. PubMed 26869288 ↗
  • 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. PubMed 25731736 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 26, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01499745
Lead sponsor
Rabin Medical Center
Responsible party
Mordechai Kremer (Prof. Mordechai Kremer Head of Pulmonary Institute, Rabin Medical Center) — Principal investigator
First posted
Dec 26, 2011
Start date
Jan 2012
Primary completion
Dec 2013 (estimated)
Completion
Dec 2013 (estimated)
Last update
Dec 26, 2011

Study contacts

Baruch Vainshelboim, M.P.E.
Contact
Baruch.v1981@gmail.com
972-39377221
Mordechai R Kramer, M.D
principal investigator · Rabin Medical Center, Belinson Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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