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BronchiectasisNCT03147651

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

An observational study of Bronchiectasis, run by Rambam Health Care Campus at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 7 years and older
Conditions the study is for
Bronchiectasis
How many people
119 participants
Where
1 siteIsrael
Study dates
Oct 2015to Dec 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Israel1 site, 1 recruiting
  • RAMBAM Health Care Campus

    Haifa, 31092

    Ronen Bar-Yoseph, MD, +972-4-777-4360, rronenfabi@gmail.com

    Recruiting

Other trials in Israel

About this study

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.

Read more

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.

Read the detailed description

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. Patients with respiratory diseases show reduced daily functional physical ability (habitual physical activity). Reasons may be due to pulmonary limitation (in severe diseases), peripheral muscular changes or due to secondary factors such as deconditioning or overly cautious caregivers restraining patient's physical activity. Deconditioning due to reduced habitual activity leads to further reduction in exercise capacity increasing the severity of their condition. While CF is the most common cause of bronchiectasis in childhood, non-CF bronchiectasis is associated with a wide variety of disorders. The etiology for non-CF bronchiectasis include: primary ciliary dyskinesia (PCD), post infectious, aspiration, primary and secondary immunodeficiency, congenital malformation, and others. Children with CF tend to perform poorly at a moderate-intensity physical activity compared to non-CF children of same age. In the last several decades, exercise has been encouraged in CF patients to improve sputum expectoration and lung function. There is evidence that exercise in addition to respiratory physical therapy, improves lung function and reduces the rate of lung function deterioration, compared with respiratory physical therapy alone. Another study showed that an aerobic training program in children contributed to significantly higher peak aerobic capacity, activity level, and subjective quality of life than children who received a resistance training program. In conclusion, higher levels of physical activity in addition to good muscular and pulmonary functions are associated with a high aerobic capacity in cystic fibrosis.

Although the exact physiologic mechanism by which exercise improves clearing of airways secretions in CF is not entirely clear, possible explanations are attributed to increased airflow and mechanical clearing of mucus. Following physical exertion there is an increase in tidal volume and respiratory flow to meet tissue demands. Increasing peak expiratory flow (PEF) to peak inspiratory flow (PIF) ratio may help drive the mucus past the oropharynx to clear more easily. Additional benefits of exercise in patients with CF are similar to the healthy population and includes overall improvement in cardiovascular health, musculoskeletal health, and quality of life. Maximal oxygen consumption (VO2peak) serves as a strong prognosis marker associated with an approximate 8-year survival in CF patients and correlates with the number of hospital admissions due to respiratory exacerbations. There is paucity of data regarding exercise capacity in non-CF bronchiectasis.

  1. Research Aim: To evaluate and compare exercise capacity in CF and non-CF bronchiectasis patients.
  2. Significance: There is limited data regarding exercise capability in non-CF bronchiectasis. CPET is increasingly gaining importance in clinical medicine. The test helps the clinician objectively evaluate the physiological functions, may help predict the outcome and mortality in different clinical circumstances and may serve as a basis for creating individualized exercise prescription within the context and limitation of the disease.
  3. Research Plan: Design: cross-sectional retrospective/prospective study population. The retrospective study will include data analysis of patients that preformed exercise tests as part of their clinical evaluation. In the prospective study, informed consent will be sign by the patient or legal guardian prior to participation. Setting: Outpatient clinic. The aim is to evaluate 50 patients with CF and 50 non-CF bronchiectasis patients 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 .

  1. Evidence of bronchiectasis in computed tomography (CT); followed at the Pediatric Pulmonary Institute.

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.

The clinic has performed tests in over 1500 adolescents, children and adults, most commonly who have chronic illness such as congestive heart failure (CHD), CF, PCD, post oncological diseases, diabetes, etc.

Methods:

Age, sex, height and weight, etiology of bronchiectasis, and chest CT will be recorded. Body mass index (BMI) will be calculated. Each patient will fill a questionnaire regarding his life style and exercise capability in real life.

CPET: Following baseline measures, each patient will undergo CPET using cycle ergometer (Cosmed, Rome, Italy). Silicone face masks will be harnessed over the subject's nose and mouth to monitor the resting and exercise gas exchange measurements. Subjects are connected to electrocardiogram (ECG), saturation and blood pressure monitors. Exercise time is 8-12 minutes and total test duration is 45-60 minutes. The test is non-invasive and within the limits of the test, it is safe. The test begins with a no resistance warm up lasting 1 to 3 minutes and followed with a gradual increment in resistance adapted to the patient's functional capacities according to the examiner's free judgment and ranging 5 to 25 Watts/minute. Pulmonary function tests rest will be recorded prior to CPET and 10 minutes post exercise. The cardio-respiratory parameters measured include respiration rate (RR), heart rate by 12-lead ECG (HR), oxygen saturation (SpO2), blood pressure (BP), tidal volume (TV), minute ventilation (VE), breathing reserve (BR), oxygen consumption (VO2), VCO2 (carbon dioxide flow rejected by the ventilation system), respiratory equivalents (VE/VO2, VE/VCO2), end tidal carbon dioxide (ETCO2), anaerobic threshold (AT), oxygen pulse (O2 pulse), respiratory exchange ratio (RER) at rest, during exercise and recovery . The combination of data collected allows analysis of the subject's ability during exercise.

Spirometry: Spirometry will be performed in accordance with ATS/ERS (American Thoracic Society/ European Respiratory Society) Task Force using a KoKo spirometer (KoKo system, PDS Inc., Ferraris Cardiopulmonary System Group; Louisville, CO, USA). Each maneuver will be repeated for at least three technically acceptable; the best results were used for analysis.

Conditions
Bronchiectasis
Keywords
Cystic fibrosis, exercise capacity, non-cystic fibrosis, bronchiectasis
Medical subject headings
Bronchiectasis, Cystic Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03147651
Study groupRoleWhat they receive
Cystic Fibrosis (CF) bronchiectasisDiagnosis of Cystic Fibrosis (CF), follow up in a CF center, evidence of bronchiectasis on computed tomography (CT).
non-Cystic Fibrosis (CF) bronchiectasisNegative evaluation for of Cystic Fibrosis (CF), evidence of bronchiectasis on computed tomography (CT).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oxygen Uptake (VO2)

    Amount of oxygen consumed per amount of time.

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

Secondary outcomes (4)
  1. Spirometry

    Pulmonary function as assessed by spirometry.

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

  2. Oxygen saturation

    Oxygen saturation during exercise test.

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

  3. Minute ventilation (VE)

    Amount of air volume inhaled per minute of measurement.

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

  4. carbon dioxide production (VCO2)

    Amount of oxygen consumed per amount of time.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2017
  2. Study startOct 2015
  3. Primary completionSep 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
119 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03147651
Sponsor's protocol ID
0048-15-RMB-CTIL
Status last verified
May 2017
First submitted
30 Apr 2017
Last updated
10 May 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31194748

Questions about this trial

What is this clinical trial studying?

An observational study of Bronchiectasis, run by Rambam Health Care Campus at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lea Bentur, Prof. (+972-4-777-4360, l_bentur@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oxygen Uptake (VO2) (time frame: Measured continuously during 15 minutes of the exercise test (CPET).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03147651, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2017.

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