NCT06322446

Exercise in People With Cystic Fibrosis on CFTR Modulator Therapy

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)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Universidad Politecnica de Madrid · Academic / Other
• Sex: All
• Age: 6 Years – 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
OTHER	Exercise	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

Timeline

• Start date: 2024-02-27
• Primary completion: 2025-12-23
• Completion: 2025-12-23
• First posted: 2024-03-21
• Last updated: 2024-03-21

Locations

1 site across 1 country: Spain