An interventional study of Exercise and Unsupervised exercise in Cystic Fibrosis in Children, sponsored by Universidad Europea de Madrid. Withdrawn at 1 site in Spain. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-12-11.
Sponsored by Universidad Europea de Madrid · Not applicable, Interventional, and Treatment
This study aims to assess the effects of programmed exercise combined with CFTR protein modulator drugs in the cardiorespiratory fitness, strength, functional capacity and agility in a group of young patients with Cystic Fibrosis.
The present study is a new clinical trial that extends our previous work intended to assess the effect of programmed exercise with or without electrical stimulation on cardiorespiratory fitness, strength, functional capacity and agility in a group of young patients with Cystic Fibrosis (ECOMIRIN) registered at ClinicalTrials.gov (Identifier: NCT04153669).
After finishing the study, a subset of the participants was treated with either TEZ/IVA or LUM/IVA per standard of care, as they were considered candidates according to the AEMPS (https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-000833-37/ES). Those patients are expected to complete five months of pharmacological treatment without exercise by June 2020.
Primary Objective To evaluate the effect of an exercise program on physical fitness in cystic fibrosis patients after 5 months of administration of LUM/IVA or TEZ/IVA in comparison to the effect produced by the same exercise program before administration of the drug.
Secondary Objectives Other specific objectives include comparing the beneficial effects of exercise and LUM/IVA or TEZ/IVA on: 1) cardiorespiratory function and muscle strength; 2) the concentration of chlorine in sweat; and 3) quality of life.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
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Exclusion Criteria:
Pharmacological treatment per standard of care (whole study length, starting on week 1). Supervised exercise protocol (phase 1, 8 weeks starting on week 9). Unsupervised exercise protocol (phase 2, 8 weeks starting on week 17).
Behavioral: Exercise · Behavioral: Unsupervised exercise · Drug: CFTR Modulators
Surpervised exercise program: Includes a concurrent exercise intervention (strength training and aerobic training), 3 days a week, 60 minutes sessions.
Unsupervised exercise program: The same exercise program learned during the supervised phase will be practiced at home.
Standard of care: Lumacaftor with Ivacaftor or Tezacaftor combined with Ivacaftor. For children between 6 and 11 years of age, Lumacaftor 400 mg combined with Ivacaftor 500 mg in total per day, divided into 2 doses per day; for those over 11 years of age, Tezacaftor 100 mg combined with Ivacaftor 150 mg in the morning, adding a dose of Ivacaftor 150 mg at night. https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-000833-37/ES
Also known as: EudraCT Number 2019-000833-37
Change in Strength
Changes in strength will be measured using a five repetition maximum test (5RM)
Time frame: Four assessment points throughout the study: baseline and after each 8-week intervention
Change in Cardiorespiratory Fitness
Changes in cardiorespiratory fitness will be measured using a cardiopulmonary exercise test (CPET)
Time frame: Four assessment points throughout the study: baseline and after each 8-week intervention
Changes in Forced expiratory volume in 1 second (FEV1)
Changes in FEV1 will be measured using Spirometry (z-score based on Global Lung Function Initiative reference DOI: 10.1016/j.arbres.2017.07.019)
Time frame: Four assessment points throughout the study: baseline and after each 8-week intervention
Changes in Forced vital capacity (FVC)
Changes in FVC will be measured using Spirometry (z-score based on Global Lung Function Initiative reference DOI: 10.1016/j.arbres.2017.07.019)
Time frame: Four assessment points throughout the study: baseline and after each 8-week intervention
Changes in FEV1/FVC ratio (FEV1%)
Changes in FEV1/FVC ratio (FEV1%) will be measured using Spirometry (z-score based on Global Lung Function Initiative reference DOI: 10.1016/j.arbres.2017.07.019)
Time frame: Four assessment points throughout the study: baseline and after each 8-week intervention
Changes in Forced expiratory flow (FEF)
Changes in FEF will be measured using Spirometry (z-score based on Global Lung Function Initiative reference DOI: 10.1016/j.arbres.2017.07.019)
Time frame: Four assessment points throughout the study: baseline and after each 8-week intervention
Changes in Physical Activity Questionnaire (PAQ) for children and adolescents
Changes in physical activity levels will be measured using PAQ-C for children under 14 years of age and PAQ-A for adolescents over 14 years of age. Items 1 to 9 will be used in the physical activity composite score, and means will be calculated to obtain the final PAQ-C activity summary score. Items 1 to 8 will be used in the physical activity composite score, and means will be calculated to obtain the final PAQ-A activity summary score. A score of 1 indicates low physical activity, whereas a score of 5 indicates high physical activity.
Time frame: Four assessment points throughout the study: baseline and after each 8-week intervention
Change in quality of life: Cystic Fibrosis-Questionnaire-Revised (CFQ-R)
Changes in quality of life will be measures with the Cystic Fibrosis-Questionnaire-Revised (CFQ-R). Scores for each health related quality of life domain are calculated; after recoding, each item is summed to generate a domain score and standardized. Scores range from 0 to 100, with higher scores indicating better health.
Time frame: Four assessment points throughout the study: baseline and after each 8-week intervention
Sweat chloride level
Chloride concentration in sweat (mEq/L) will be measured in the laboratory using an MK II Chloride Analyzer 926S
Time frame: Four assessment points throughout the study: baseline and after each 8-week intervention
This study is withdrawn, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Universidad Europea de Madrid