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OpenTrials
Completed

NCT Number: NCT05173194

Remotely Supervised Exercise for Adults With Cystic Fibrosis

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Inflammation Lung Diseases Pancreatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital La Princesa

Madrid, 28006, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Other

Eight-week program of a remotely supervised resistance exercise. Frequency: three times per week. Duration: 60 minutes per session. Training program: warm-up and joint mobility; strength exercises for different muscle groups; and cool down (stretching and breathing exercises).

Primary outcomes

  1. 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.

    Time frame: Baseline and 8 weeks

    Change from baseline to 8 weeks

  2. Change in body composition (muscle mass and skeletal mass index - kg/m2) measured through dual-energy x-ray absorptiometry (DEXA)

    Time frame: Baseline and 8 weeks

    Change from baseline to 8 weeks

  3. Change in plasmatic levels of Klotho

    Time frame: Baseline and 8 weeks

    Change from baseline to 8 weeks

  4. Change in plasmatic levels of interleukins (IL-8 and IL-10)

    Time frame: Baseline and 8 weeks

    Change from baseline to 8 weeks

Secondary outcomes

  1. Change in Pulmonary Function (Lung Function)

    Time frame: Baseline and 8 weeks

    Change from baseline to 8 weeks

  2. 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.

    Time frame: Baseline and 8 weeks

    Change from baseline to 8 weeks

  3. Change in inspiratory muscle strength (MIP)

    Time frame: Baseline and 8 weeks

    Change from baseline to 8 weeks

  4. Change in functional capacity (30 seconds sit-to-stand test)

    Time frame: Baseline and 8 weeks

    Change from baseline to 8 weeks

Sponsors and collaborators

Lead sponsor

Universidad Europea de Madrid

Other

Registry information

Official study title

Effects of a Remotely Supervised Exercise Program on Inflammatory Markers, Muscle Strength and Lung Function in Adult Patients With Cystic Fibrosis

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 29, 2021
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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