CompletedNot Applicable

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

Germany70 participantsStarted 2021-10-15

Plain-language summary

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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

change in Peak Oxygen Uptake

Timeframe: at baseline and after 4 weeks of exercise training program

change in Peak Workload

Timeframe: at baseline and after 4 weeks of exercise training program

change body fat mass index

Timeframe: at baseline and after 4 weeks of exercise training program

change in Body fat free mass index

Timeframe: at baseline and after 4 weeks of exercise training program

Trial details

NCT IDNCT05140967

SponsorUniversity of Kiel

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-31

View on ClinicalTrials.gov More Cystic Fibrosis trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

change in Peak Oxygen Uptake

Timeframe: at baseline and after 4 weeks of exercise training program

change in Peak Workload

Timeframe: at baseline and after 4 weeks of exercise training program

change body fat mass index

Timeframe: at baseline and after 4 weeks of exercise training program

change in Body fat free mass index

Timeframe: at baseline and after 4 weeks of exercise training program