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Completed

NCT Number: NCT05140967

Effects of Training Intensity on Physical Fitness and Body Composition in Cystic Fibrosis

Aim of the randomized controlled trial is to investigate the effects of endurance training with different intensities on physical performance, body composition and appetite regulation in people 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 Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fachklink Satteldüne der DRV Nord, Nebel / Amrum, Schleswig-Holstein, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • confirmed diagnosis of cystic fibrosis by at least 2 sweat tests and / or by the presence of two CF mutations,
  • willingness to participate in and to comply with the research project procedure,
  • written informed consent of patients,
  • age ≥ 18 years,
  • FEV1 of pred. ≥ 40%,
  • Stable condition (as indicated by absence of one or more signs: new or increased haemoptysis, increased malaise, fatigue or lethargy, temperature over 38°C, weight loss, sinus pain and a decrease in pulmonary function by 10% or more)

Exclusion criteria

  • Severe pulmonary exacerbation,
  • cor pulmonale,
  • musculoskeletal discomfort that makes a regular exercise training impossible,
  • untreated CF-related diabetes

Treatment and study plan

High Intensity Interval Training (HIIT)

Other

High Intensity Interval Training

Moderate Continuous Intensity Training (MICT)

Other

Moderate Intensity Continuous Training

Primary outcomes

  1. change in Peak Oxygen Uptake

    Time frame: at baseline and after 4 weeks of exercise training program

    measured with peak Oxygen uptake (VO2) in percent predicted

  2. change in Peak Workload

    Time frame: at baseline and after 4 weeks of exercise training program

    measured with peak Workload in percent predicted

  3. change body fat mass index

    Time frame: at baseline and after 4 weeks of exercise training program

    measured with body fat mass index (FMI) in kg / m*2

  4. change in Body fat free mass index

    Time frame: at baseline and after 4 weeks of exercise training program

    measured with fat free body mass index (FFMI) in kg / m*2

Secondary outcomes

  1. change in Forced Expiratory Volume in 1 second

    Time frame: at baseline and after 4 weeks of exercise training program

    measured with Forced Expiratory Volume in 1 second (FEV1) in percent predicted

  2. change in Health related quality of life

    Time frame: at baseline and six and twelve months after completion of exercise training program

    measured with the Cystic Fibrosis Questionnaire Revised (CFQ-R); 9 Quality of life domains: Physical, role/school, vitality, emotion, social, body image, eating, treatment burden, health perceptions: 3 symptom scales: Weight, respiratory, and digestion Scores range from 0 to 100, with higher scores indicating better health.

  3. appetite control - subjective feeling of hunger

    Time frame: at baseline and after 4 weeks of exercise training program

    measured with visual analogue scales. The scale consists of a 10 cm vertical line anchored with "not hungry at all" at the left side and with "extremely hungry" at the right side.

Sponsors and collaborators

Lead sponsor

University of Kiel

Other

Collaborators

  • Fachklinik Satteldüne der DRV Nord
  • Strandklinik St. Peter-Ording
  • University of Kiel, Arbeitsbereich Sportmedizin und Trainingswissenschaften

Registry information

Official study title

Effects of Endurance Training Intensity on Exercise Capacity, Body Composition, and Appetite Regulation in Cystic Fibrosis

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Dec 2, 2021
Registry last updated
Feb 17, 2025

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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