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: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 20
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Facultad de Ciencias de la Actividad Física y Deporte - INEF UPM
RECRUITING
Madrid
Contact Information
Primary
Margarita Pérez Ruiz, PhD
margarita.perez@upm.es
+34910677960
Time Frame
Start Date: 2024-02-27
Estimated Completion Date: 2025-12-23
Participants
Target number of participants: 48
Treatments
Experimental: Intervention
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.
No_intervention: Control
Control group will follow routine recommendations from the multidisciplinary CF team based on WHO´s guidelines
Related Therapeutic Areas
Sponsors
Collaborators: Hospital Infantil Universitario Niño Jesús, Madrid, Spain, Universidad Europea de Madrid, Hospital Universitario La Paz, Hospital Universitario Ramon y Cajal, Carlos III Health Institute
Leads: Universidad Politecnica de Madrid

This content was sourced from clinicaltrials.gov