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

NCT03147651 | Unknown

• 1 other identifier: 0048-15-RMB-CTIL
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis

Keywords

Cystic fibrosis; exercise capacity; non-cystic fibrosis; bronchiectasis

Outcome Measures

Primary Outcomes (1)

• Oxygen Uptake (VO2)

  Amount of oxygen consumed per amount of time.

  Measured continuously during 15 minutes of the exercise test (CPET).

Secondary Outcomes (4)

• Spirometry

  5 minutes of evaluation, completed pre and post exercise test (CPET).

• Oxygen saturation

  Measured continuously during 15 minutes of the exercise test (CPET).

• Minute ventilation (VE)

  Measured continuously during 15 minutes of the exercise test (CPET).

• carbon dioxide production (VCO2)

  Measured continuously during 15 minutes of the exercise test (CPET).

Study Arms (2)

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).

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

CF and non-CF Bronchiectasis patients evaluated by CPET as part as their clinic follow up.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

RAMBAM Health Care Campus

Haifa, 31092, Israel

RECRUITING

Related Publications (1)

• Bar-Yoseph R, Ilivitzki A, Cooper DM, Gur M, Mainzer G, Hakim F, Livnat G, Schnapp Z, Shalloufeh G, Zucker-Toledano M, Subar Y, Bentur L. Exercise capacity in patients with cystic fibrosis vs. non-cystic fibrosis bronchiectasis. PLoS One. 2019 Jun 13;14(6):e0217491. doi: 10.1371/journal.pone.0217491. eCollection 2019.

  PMID: 31194748 DERIVED

MeSH Terms

Conditions

Bronchiectasis; Cystic Fibrosis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Lea Bentur, Prof.

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lea Bentur, Prof.

CONTACT

+972-4-777-4360; l_bentur@rambam.health.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2017
• First Posted: May 10, 2017
• Study Start: October 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 10, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)