search
Back to results

Exercise Training at Ambulatory Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis Patients

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Pulmonary Rehabilitation
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring Idiopathic pulmonary fibrosis (IPF) patients

Eligibility Criteria

30 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pulmonary Institute, Rabin Medical Center, Beilinson Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Exercise Training at Pulmonary Rehabilitation Program

Standard Treatment for IPF

Arm Description

Exercise Training at Pulmonary Rehabilitation Program 2 weekly sessions of 60 min for 12 weeks

Continue for normal live with standard treatment

Outcomes

Primary Outcome Measures

Peak VO2
Peak oxygen consumption during standart cardiopulmonary exercise test on bicycle argometer
6 min walk test
distance covered in meters during 6 min of walking

Secondary Outcome Measures

Echocardiography Parameters
Stroke Volume, Cardiac Output, Pulmonary Arterial Systolic Pressure
Blood tests
NT-proBNP, CRP
Medical Research Council (MRC) dyspnea score questionnaire
St George's Respiratory Questionnaire (SGRQ) for evaluation quality of life
International Physical Activity Questionnaire (IPAQ)- for estimation physical activity level
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
Pulmonary function test
FVC, FEV1, FEV1\FVC, TLC, DLCO, FRC.

Full Information

First Posted
December 20, 2011
Last Updated
December 22, 2011
Sponsor
Rabin Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01499745
Brief Title
Exercise Training at Ambulatory Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis Patients
Official Title
Exercise Training at Ambulatory Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
Idiopathic pulmonary fibrosis (IPF) patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise Training at Pulmonary Rehabilitation Program
Arm Type
Active Comparator
Arm Description
Exercise Training at Pulmonary Rehabilitation Program 2 weekly sessions of 60 min for 12 weeks
Arm Title
Standard Treatment for IPF
Arm Type
Placebo Comparator
Arm Description
Continue for normal live with standard treatment
Intervention Type
Behavioral
Intervention Name(s)
Pulmonary Rehabilitation
Intervention Description
Exercise Training in Pulmonary Rehabilitation Program: 12 weeks of 60 min exercise bout, twice a week at pulmonary rehabilitation
Primary Outcome Measure Information:
Title
Peak VO2
Description
Peak oxygen consumption during standart cardiopulmonary exercise test on bicycle argometer
Time Frame
Before and after 12 weeks of Pulmonary Rehabilitation
Title
6 min walk test
Description
distance covered in meters during 6 min of walking
Time Frame
Before and after 12 weeks of Pulmonary Rehabilitation
Secondary Outcome Measure Information:
Title
Echocardiography Parameters
Description
Stroke Volume, Cardiac Output, Pulmonary Arterial Systolic Pressure
Time Frame
Before and after 12 weeks of Pulmonary Rehabilitation
Title
Blood tests
Description
NT-proBNP, CRP
Time Frame
Before and after 12 weeks of Pulmonary Rehabilitation
Title
Medical Research Council (MRC) dyspnea score questionnaire
Time Frame
Before and after 12 weeks of Pulmonary Rehabilitation
Title
St George's Respiratory Questionnaire (SGRQ) for evaluation quality of life
Time Frame
Before and after 12 weeks of Pulmonary Rehabilitation
Title
International Physical Activity Questionnaire (IPAQ)- for estimation physical activity level
Time Frame
Before and after 12 weeks of Pulmonary Rehabilitation
Title
Battery of 4 functional tests
Description
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
Title
Pulmonary function test
Description
FVC, FEV1, FEV1\FVC, TLC, DLCO, FRC.
Time Frame
Before and after 12 weeks of Pulmonary Rehabilitation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baruch Vainshelboim, M.P.E.
Phone
972-39377221
Email
Baruch.v1981@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mordechai R Kramer, M.D
Organizational Affiliation
Rabin Medical Center, Belinson Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pulmonary Institute, Rabin Medical Center, Beilinson Hospital
City
Petach Tikva
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baruch Vainshelboim, M.P.E.
Phone
972-39377221
Email
Baruch.v1981@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
30600393
Citation
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.
Results Reference
derived
PubMed Identifier
27165419
Citation
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.
Results Reference
derived
PubMed Identifier
26869288
Citation
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.
Results Reference
derived
PubMed Identifier
25731736
Citation
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.
Results Reference
derived

Learn more about this trial

Exercise Training at Ambulatory Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis Patients

We'll reach out to this number within 24 hrs