Remotely Supervised Exercise for Adults With Cystic Fibrosis

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Other: Exercise

• Registration Number: NCT05173194
• Lead Sponsor: Universidad Europea de Madrid

Brief Summary

Cystic fibrosis (CF) is a genetic disease characterized by abnormal chloride transport in epithelial tissues. Inflammation is a key component contributing to the main alterations induced by the disease. The increase in life expectancy comes with a higher prevalence of CF-related comorbidities, but also with new emerging complications directly related to aging. Physical fitness and exercise practice have been previously associated to survival and better quality of life in patients with cystic fibrosis. Thus, the aim of this study is to assess the effects of a remotely supervised resistance exercise program on lung function, muscle strength, body composition, quality of life and inflammatory markers in adult patients with cystic fibrosis.

Detailed Description

This study aims to assess the effects of a remotely supervised resistance exercise program on lung function, muscle strength, body composition, quality of life and inflammatory markers in adult patients with cystic fibrosis.

Study Timeline

• Study Start: 2021-10-26
• Study First Submitted: 2021-11-23
• Study First Submitted QC: 2021-12-10
• Study First Posted: 2021-12-29
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-03
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Confirmed clinical and genetic diagnosis for cystic fibrosis;
• Age from 16 years.

Exclusion Criteria

• Musculoskeletal disorders that do not allow the performance of physical exercise;
• Pregnancy;
• Absence of registration of clinical required.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telematic Exercise	Exercise	A remotely supervised resistance exercise program will be carried out for 8 weeks, with three 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.

Primary Outcome Measures

Name	Time	Method
Change in plasmatic levels of Klotho	Baseline and 8 weeks	Change from baseline to 8 weeks
Change in peripheral muscle strength. Upper and lower limb muscle strength will be evaluated using the 5 maximum repetition test in specific strength machines. Handgrip strength will be measured with a dynamometer.	Baseline and 8 weeks	Change from baseline to 8 weeks
Change in body composition (muscle mass and skeletal mass index - kg/m2) measured through dual-energy x-ray absorptiometry (DEXA)	Baseline and 8 weeks	Change from baseline to 8 weeks
Change in plasmatic levels of interleukins (IL-8 and IL-10)	Baseline and 8 weeks	Change from baseline to 8 weeks

Secondary Outcome Measures

Name	Time	Method
Change in Pulmonary Function (Lung Function)	Baseline and 8 weeks	Change from baseline to 8 weeks
Change in quality of life evaluated using the Cystic Fibrosis Questionnaire (CFQ-R +14). Scores range from 0 to 100 with higher scores corresponding to better quality of life.	Baseline and 8 weeks	Change from baseline to 8 weeks
Change in inspiratory muscle strength (MIP)	Baseline and 8 weeks	Change from baseline to 8 weeks
Change in functional capacity (30 seconds sit-to-stand test)	Baseline and 8 weeks	Change from baseline to 8 weeks

Trial Locations

Locations (1)

Hospital La Princesa; 🇪🇸 Madrid, Spain