Exercise program for children and adolescents with cystic fibrosis on new medication
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)
This study is testing whether a special exercise program can help kids and teens with cystic fibrosis who are on new medications improve their muscle health and overall fitness.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 6 Years to 20 Years |
| Sex | All |
| Sponsor | Universidad Politecnica de Madrid Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT06322446 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of a telematic exercise intervention on muscle health in children and adolescents with cystic fibrosis (CF) who are being treated with new CFTR modulators. Participants will be randomly assigned to either an exercise group or a control group, and the study will measure various outcomes including muscle strength, cardiorespiratory fitness, lung function, body composition, and inflammatory biomarkers. The trial aims to assess the impact of strength-based exercise on these health metrics over a six-month period, with follow-up on adherence and clinical evolution after one year.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 6-20 diagnosed with cystic fibrosis who are currently receiving new CFTR modulator therapy.
Not a fit: Patients experiencing pulmonary exacerbations, other significant lung diseases, or musculoskeletal issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance muscle health and overall fitness in young patients with cystic fibrosis, potentially improving their quality of life.
How similar studies have performed: Other studies have shown positive outcomes with exercise interventions in cystic fibrosis, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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;
Where this trial is running
Madrid
- Facultad de Ciencias de la Actividad Física y Deporte - INEF UPM — Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Margarita Perez Ruiz, PhD — Universidad Politecnica de Madrid
- Study coordinator: Margarita Pérez Ruiz, PhD
- Email: margarita.perez@upm.es
- Phone: +34910677960
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.