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Exercise Capacity in Patients With Cystic Fibrosis vs. Non-cystic Fibrosis Bronchiectasis

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ClinicalTrials.gov Identifier: NCT03147651
Recruitment Status : Unknown
Verified May 2017 by Rambam Health Care Campus.
Recruitment status was:  Recruiting
First Posted : May 10, 2017
Last Update Posted : May 10, 2017
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus

Brief Summary:

Introduction: Bronchiectasis is a chronic lung disease in which the underlying condition causes permanent damage to the conducting airways. Bronchiectasis is associated with considerable morbidity and poor quality of life. While cystic fibrosis (CF) is the most common cause of bronchiectasis in childhood, non-CF bronchiectasis is associated with a wide variety of disorders. CF bronchiectasis patients show reduced daily habitual physical activity and exercise capacity. Cardiopulmonary exercise test (CPET) is increasingly gaining importance in clinical medicine and considered the gold standard exercise test for assessing aerobic exercise capacity. The test objectively evaluates exercise physiological functions, may help assess morbidity and predict the outcome and mortality in different clinical circumstances and may serve as a basis for individualized exercise prescription within the limitation of the disease. Unlike CPET in CF, there is a paucity of data on exercise capacity using CPET in non- CF bronchiectasis patients, and on the implications of physical activity on non- CF bronchiectasis morbidity and mortality.

Aim: To evaluate and compare exercise capacity in CF and non-CF bronchiectasis patients.

Methods: This will be a cross-sectional retrospective/prospective study population. The retrospective study will include data analysis of patients that preformed CPET as part of their clinical evaluation. In the prospective study, patients that are scheduled to perform CPET as part of their clinical evaluation will sign (or legal guardian) informed consent prior to participation. Patients will be recruited from the exercise clinic at the Pediatric Pulmonary Institute at the Rappaport Children's Hospital. Inclusion criteria: 1. Children and adults (age >7 years, height >125cm), with CF and non CF bronchiectasis. 2. Completed a maximal CPET test according to accepted criteria; (maximal VO2 > 80% predicted, maximal heart rate > 80% predicted, acceptable RER (RER > 1.0 in children (under 18 years), RER > 1.05 for adults) or reaching a VO2 plateau..3. Evidence of bronchiectasis in computed tomography (CT).

Exclusions criteria: preforming submaximal CPET, lack of data from the exercise test, exacerbation of patient's condition within three days before the exercise evaluation, relevant related chronic diseases that affecting test results.


Condition or disease
Bronchiectasis

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 119 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Exercise Capacity in Patients With Cystic Fibrosis vs. Non-cystic Fibrosis Bronchiectasis
Actual Study Start Date : October 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 2017


Group/Cohort
Cystic Fibrosis (CF) bronchiectasis
Diagnosis of Cystic Fibrosis (CF), follow up in a CF center, evidence of bronchiectasis on computed tomography (CT).
non-Cystic Fibrosis (CF) bronchiectasis
Negative evaluation for of Cystic Fibrosis (CF), evidence of bronchiectasis on computed tomography (CT).



Primary Outcome Measures :
  1. Oxygen Uptake (VO2) [ Time Frame: Measured continuously during 15 minutes of the exercise test (CPET). ]
    Amount of oxygen consumed per amount of time.


Secondary Outcome Measures :
  1. Spirometry [ Time Frame: 5 minutes of evaluation, completed pre and post exercise test (CPET). ]
    Pulmonary function as assessed by spirometry.

  2. Oxygen saturation [ Time Frame: Measured continuously during 15 minutes of the exercise test (CPET). ]
    Oxygen saturation during exercise test.

  3. Minute ventilation (VE) [ Time Frame: Measured continuously during 15 minutes of the exercise test (CPET). ]
    Amount of air volume inhaled per minute of measurement.

  4. carbon dioxide production (VCO2) [ Time Frame: Measured continuously during 15 minutes of the exercise test (CPET). ]
    Amount of oxygen consumed per amount of time.



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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
CF and non-CF Bronchiectasis patients evaluated by CPET as part as their clinic follow up.
Criteria

Inclusion Criteria:

  • Evidence of bronchiectasis on computed tomography (CT)
  • Age > 7 years
  • Height > 125cm
  • Completed a maximal CPET test according to the accepted criteria

Exclusion Criteria:

  • Preforming submaximal CPET
  • Lack of data from the exercise test
  • Exacerbation of patient's condition within three days before the exercise evaluation
  • Related chronic diseases affecting test results

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03147651


Contacts
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Contact: Lea Bentur, Prof. +972-4-777-4360 l_bentur@rambam.health.gov.il

Locations
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Israel
RAMBAM Health Care Campus Recruiting
Haifa, Israel, 31092
Contact: Ronen Bar-Yoseph, MD    +972-4-777-4360    rronenfabi@gmail.com   
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Lea Bentur, Prof. Rambam Health Care Campus
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT03147651    
Other Study ID Numbers: 0048-15-RMB-CTIL
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rambam Health Care Campus:
Cystic fibrosis
exercise capacity
non-cystic fibrosis
bronchiectasis
Additional relevant MeSH terms:
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Cystic Fibrosis
Bronchiectasis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Bronchial Diseases