Clinical trial NCT05173194: Remotely Supervised Exercise for Adults With Cystic Fibrosis
Official title: Effects of a Remotely Supervised Exercise Program on Inflammatory Markers, Muscle Strength and Lung Function in Adult Patients With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Cystic fibrosis
Exercise program
Lung funcion
Inflammation
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 32
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Baseline and 8 weeks
measure: Change in body composition (muscle mass and skeletal mass index - kg/m2) measured through dual-energy x-ray absorptiometry (DEXA)
timeFrame: Baseline and 8 weeks
measure: Change in plasmatic levels of Klotho
timeFrame: Baseline and 8 weeks
measure: Change in plasmatic levels of interleukins (IL-8 and IL-10)
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Change in Pulmonary Function (Lung Function)
timeFrame: Baseline and 8 weeks
measure: 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.
timeFrame: Baseline and 8 weeks
measure: Change in inspiratory muscle strength (MIP)
timeFrame: Baseline and 8 weeks
measure: Change in functional capacity (30 seconds sit-to-stand test)
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital La Princesa
Study officials:
affiliation: Universidad Politecnica de Madrid
name: Margarita Perez-Ruiz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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