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ACTIVE NOT RECRUITING
NCT06322446
NA

Exercise in People With Cystic Fibrosis on CFTR Modulator Therapy

Sponsor: Universidad Politecnica de Madrid

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

6 Years - 20 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2024-02-27

Completion Date

2026-06-04

Last Updated

2026-05-01

Healthy Volunteers

No

Conditions

Interventions

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

Locations (1)

Facultad de Ciencias de la Actividad Física y Deporte - INEF UPM

Madrid, Madrid, Spain