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L'essai clinique NCT06322446 (FIQMODE) pour Fibrose kystique est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Exercise in People With Cystic Fibrosis on CFTR Modulator Therapy (FIQMODE)

En recrutement
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L'étude clinique NCT06322446 (FIQMODE) est un essai interventionnel pour Fibrose kystique. Son statut actuel est : en recrutement. L'étude a débuté le 27 février 2024 et vise à recruter 48 participants. Dirigé par Universidad Politecnica de Madrid, l'essai devrait être terminé d'ici le 23 décembre 2025. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 21 mars 2024.
Résumé succinct
Recently, the treatment of Cystic Fibrosis (CF) incorporated new modulators/enhancers of the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR). It is thus increasingly important to study the side effects of these drugs, their extrapulmonary effects and possible interaction with other drugs and with exercise. For this purpose, a randomized controlled trial is proposed to determine the effects of a telematic exercise intervention on muscle health, in a group of 48 children and adolescents with CF treated with these new generation CFTR modulators. They will be randomly assigned to two groups (exercise and control group). The effect of the intervention will be analysed measuring the variables of muscle health, cardiorespiratory fitness, lung function, body composition, inflammatory biomarkers and miRNAs. After completion of the intervention program, adherence to exercise and clinical evolution after one year will be analysed.
Description détaillée

Specific objectives

  1. To determine the effects of a strength exercise intervention in a group of children and adolescents with cystic fibrosis treated with new generation CFTR modulators on: (1.i) peripheral muscle strength; (1.ii) respiratory muscle strength; (1.iii) muscle mass and (1.iv) biomarkers of muscle damage.
  2. To determine the effects of a strength exercise intervention in a group of children and adolescents with cystic fibrosis being treated with new generation CFTR modulators on: (2.i) cardiorespiratory fitness; (2.ii) body composition and (2.iii) lung function.
  3. To determine the effects of a strength-based exercise intervention in a group of children and adolescents with cystic fibrosis treated with new-generation CFTR modulators on: (3.i) biomarkers of inflammatory status and (3.ii) expression of associated miRNAs.
  4. To determine the effects of a strength-based exercise intervention in a group of children and adolescents with cystic fibrosis treated with the new generation CFTR modulators on the levels of Elexaxcaftor/Ivacaftor/Tezacaftor and their metabolites.
  5. To assess the clinical evolution and adherence to exercise after 6 months of the programme in children and adolescents with cystic fibrosis treated with the new generation of CFTR modulators.
Titre officiel

Effects of a Strength Exercise Program on Muscular Health in People With CF Treated With Modulators of the Cystic Fibrosis Transmembrane Conductance Regulator Receptor (CFTR)

Conditions
Fibrose kystique
Publications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:
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Autres identifiants de l'essai
  • FIQMODE
  • PI23/00299
Numéro NCT
NCT06322446
Date de début (réel)
2024-02-27
Dernière mise à jour publiée
2024-03-21
Date de fin (estimée)
2025-12-23
Inscription (estimée)
48
Type d'essai
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
Physical Fitness
Muscle Strength
Resistance Training
Lung funcion
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Simple aveugle
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalIntervention
Telematic Exercise: A remotely supervised resistance exercise program will be carried out for 16 weeks, with two weekly sessions lasting approximately 60 minutes each. Training will be performed in groups of four patients, according to their lung function/physical fitness. The first training session will be on site (University) for familiarization, planning and adjustment of the exercises, and the following sessions will be performed online. Each session is divided into: (i) Warm-up and joint mobility; (ii) main part: strength exercises for different muscle groups; and (iii) cool down: stretching and breathing exercises.
EXERCICE
16-week exercise intervention: At the beginning of the intervention, we will conduct a face-to-face familiarisation session with the exercises of the training programme. The intervention will consist of 2 sessions/week for 16 weeks. Each session consists of three stages: (i) Warm-up: 10 min of joint mobility and low intensity exercises involving the musculature to be worked in that session; (ii) Main part: circuit training mainly composed of strength exercises targeting the different muscle groups of the body and playing activities (iii) Cool down: 10 min with guided breathing work and stretching of the main muscle groups worked
Aucune interventionControl
Control group will follow routine recommendations from the multidisciplinary CF team based on WHO´s guidelines
N/A
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
Changes in peripheral muscle strength
Upper and lower limbs muscle strength (kg) will be evaluated using dynamometers.
Baseline, pre-intervention and immediately after the intervention.
Changes in inspiratory/expiratory muscle strength (MIP/MEP) (cmH2O)
Inspiratory and expiratory muscle strength: maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be measured.
Baseline, pre-intervention and immediately after the intervention
Changes in functional capacity: lower limbs power capacity
30 seconds sit-to-stand test. Unit of measurement: number of repetitions.
Baseline, pre-intervention and immediately after the intervention
Changes in functional capacity: walking capacity
10m Time (s) Up and Go tests.
Baseline, pre-intervention and immediately after the intervention
Change in Cardiorespiratory fitness: maximal oxygen consumption
To assess cardiorespiratory fitness, a treadmill and a gas analyser will be used. The test aims to determine maximal oxygen consumption (VO2peak in ml/kg/min). VO2peak will be recorded as the highest value obtained during a continuous 30 s period.
Baseline, pre-intervention and immediately after the intervention
Change in Cardiorespiratory fitness: Ventilatory threshold VT1
To assess cardiorespiratory fitness, a treadmill and a gas analyser will be used. The test aims to determine the ventilatory threshold VT1 in response to maximal effort. VT1 will be determined using the criteria of an increase in both ventilatory equivalent for oxygen consumption (VE/VO2) and end-tidal oxygen pressure without an increase in ventilatory equivalent for carbon dioxide production (VE/VCO2).
Baseline, pre-intervention and immediately after the intervention
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
Changes in Pulmonary Function: forced vital capacity (FVC)
Spirometry will assess: forced vital capacity (FVC) in milliliters and percentage of predicted value
Baseline, pre-intervention and immediately after the intervention
Changes in Pulmonary Function: Forced expiratory volume in the first second (FEV1)
Spirometry will assess: forced expiratory volume in the first second (FEV1).Data will be expressed in absolute values and z-score based on the Global Lung Initiative (GLI) reference equation establishing as a limit of normality (LIN) a z-score value for FEV1 between -1.64 and + 1.64.
Baseline, pre-intervention and immediately after the intervention
Changes in the anthropometric and body composition: Weight
Weight (kg)
Baseline, pre-intervention and immediately after the intervention
Changes in the anthropometric and body composition: Height
Height (cm)
Baseline, pre-intervention and immediately after the intervention
Changes in the anthropometric and body composition: BMI
BMI (kg/m2)
Baseline, pre-intervention and immediately after the intervention
Changes in body composition: Total fat mass
Total fat mass (kg)
Baseline, pre-intervention and immediately after the intervention
Changes in body composition: FMI
fat mass index (FMI) (kg/m2),
Baseline, pre-intervention and immediately after the intervention
Changes in body composition: lean mass kg
Lean mass in kg
Baseline, pre-intervention and immediately after the intervention
Changes in body composition: lean mass %
Lean mass in %
Baseline, pre-intervention and immediately after the intervention
Changes in quality of life using the Cystic Fibrosis Questionnaire
Scores range from 0 to 100 with higher scores corresponding to better quality of life.
Baseline, pre-intervention and immediately after the intervention
Changes in plasma levels muscle damage biomarkers
Blood levels biomarkers of muscle damage as CK measured in micrograms per litre (mcg/L)
Baseline, pre-intervention and immediately after the intervention
Changes in plasma levels of inflammation: hs-CRP
High-sensitivity C-reactive protein (hs-CRP) assay in milligrams/litre
Baseline, pre-intervention and immediately after the intervention
Changes in plasma levels of inflammation: Interleukins
Analysis of interleukins such as IL6, IL-10 in picograms/millilitre
Baseline, pre-intervention and immediately after the intervention
Critères d'éligibilité

Âges éligibles
Enfant, Adulte
Âge minimum
6 Years
Sexes éligibles
Tous
  • patients diagnosed with CF.
  • patients between 6-20 years of age.
  • patients receiving treatment with new CFTR protein modulating medication
  • reading, acceptance and signing of the informed consent form.

  • CF patients with symptoms of pulmonary exacerbation during the last four weeks.
  • with a diagnosis of other cardiorespiratory lung diseases progressing to a symptom of persistent respiratory dysfunction.
  • CF patients with musculoskeletal alterations that influence assessments.
  • CF patient who is pregnant during the time of the study
  • CF patient with cognitive impairment;
  • CF patient with incomplete dosing of modulator therapy;
Universidad Politecnica de Madrid logoUniversidad Politecnica de Madrid
  • ⚕️Carlos III Health Institute
  • 🏛️Universidad Europea de Madrid
  • 🏥Hospital Universitario La Paz
  • 🏥Hospital Universitario Ramon y Cajal
  • 🏥Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Partie responsable de l'essai
Margarita Pérez-Ruiz, Investigateur principal, full professor in Physical Activity and Health, Universidad Politecnica de Madrid
Contact central de l'essai
Contact: Margarita Pérez Ruiz, PhD, +34910677960, [email protected]
1 Centres de l'essai dans 1 pays
Facultad de Ciencias de la Actividad Física y Deporte - INEF UPM, Madrid, 28040, Spain
Marcela González Gross, PhD, Contact, +34910677980, [email protected]
Margarita M Pérez-Ruiz, PhD, Investigateur principal
Marcela González-Gross, PhD, Investigateur associé
En recrutement