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

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Brief Title

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

Official Title

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

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.
    

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.

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

      4. 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.

      5. 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 .

      3. 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.
    


Study Type

Observational


Primary Outcome

Oxygen Uptake (VO2)

Secondary Outcome

 Spirometry

Condition

Bronchiectasis


Study Arms / Comparison Groups

 Cystic Fibrosis (CF) bronchiectasis
Description:  Diagnosis of Cystic Fibrosis (CF), follow up in a CF center, evidence of bronchiectasis on computed tomography (CT).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

119

Start Date

October 2015

Completion Date

December 2017

Primary Completion Date

September 2017

Eligibility 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
      

Gender

All

Ages

7 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Lea Bentur, Prof., +972-4-777-4360, [email protected]

Location Countries

Israel

Location Countries

Israel

Administrative Informations


NCT ID

NCT03147651

Organization ID

0048-15-RMB-CTIL


Responsible Party

Sponsor

Study Sponsor

Rambam Health Care Campus


Study Sponsor

Lea Bentur, Prof., Principal Investigator, Rambam Health Care Campus


Verification Date

May 2017