Cystic FibrosisNCT05140967
Effects of Training Intensity on Physical Fitness and Body Composition in Cystic Fibrosis
A study testing High Intensity Interval Training (HIIT) and Moderate Continuous Intensity Training (MICT) in people with Cystic Fibrosis, run by University of Kiel at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- High Intensity Interval Training (HIIT) and Moderate Continuous Intensity Training (MICT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesGermany
- Study dates
- 15 Oct 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Severe pulmonary exacerbation,
- cor pulmonale,
- musculoskeletal discomfort that makes a regular exercise training impossible,
- untreated CF-related diabetes
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Fachklink Satteldüne der DRV Nord
Nebel / Amrum, Schleswig-Holstein, 25946
Strandklinik St. Peter-Ording
Sankt Peter-Ording, Schleswig-Holstein, 25826
About this study
Official title: Effects of Endurance Training Intensity on Exercise Capacity, Body Composition, and Appetite Regulation 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.
- Conditions
- Cystic Fibrosis
- Being tested
- High Intensity Interval Training (HIIT), Moderate Continuous Intensity Training (MICT)
- Keywords
- Exercise training, High Intensity Interval Training (HIIT), Moderate Intensity Continuous Training (MICT), Exercise capacity, Peak Oxygen uptake (VO2peak), Body-composition, Subjective appetite and satiety ratings, Appetite regulating hormones, Health related quality of life, Habitual physical activity, ad libitum energy intake
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval Training (HIIT)Other
High Intensity Interval Training
Moderate Continuous Intensity Training (MICT)Other
Moderate Intensity Continuous Training
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training (A) | Experimental | Exercise training with intermittent bouts of high intensity Receives: Other: High Intensity Interval Training (HIIT) |
| Moderate Intensity Continous Training (B) | Experimental | Exercise training with constant workload Receives: Other: Moderate Continuous Intensity Training (MICT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Peak Oxygen Uptake
measured with peak Oxygen uptake (VO2) in percent predicted
Measured: at baseline and after 4 weeks of exercise training program
change in Peak Workload
measured with peak Workload in percent predicted
Measured: at baseline and after 4 weeks of exercise training program
change body fat mass index
measured with body fat mass index (FMI) in kg / m*2
Measured: at baseline and after 4 weeks of exercise training program
change in Body fat free mass index
measured with fat free body mass index (FFMI) in kg / m*2
Measured: at baseline and after 4 weeks of exercise training program
Secondary outcomes (3)
change in Forced Expiratory Volume in 1 second
measured with Forced Expiratory Volume in 1 second (FEV1) in percent predicted
Measured: at baseline and after 4 weeks of exercise training program
change in Health related quality of life
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.
Measured: at baseline and six and twelve months after completion of exercise training program
appetite control - subjective feeling of hunger
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.
Measured: at baseline and after 4 weeks of exercise training program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start15 Oct 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kiel
- Sponsor type
- University, hospital or other
- Collaborators
- Fachklinik Satteldüne der DRV Nord, University of Kiel, Arbeitsbereich Sportmedizin und Trainingswissenschaften, Strandklinik St. Peter-Ording
- Responsible party
- Principal investigator, Prof. Dr. Dr. Anja Bosy-Westphal, University of Kiel
- Investigators
- Anja Bosy-Westhphal, Prof, PhD, MD, Study chair, Insitute of Human Nutrition, University of Kiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140967
- Sponsor's protocol ID
- ABW-2021-CF
- Status last verified
- Feb 2025
- First submitted
- 29 Oct 2021
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Endurance Training Intensity on Exercise Capacity, Body Composition, and Appetite Regulation in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT05140967
- Acronym / sponsor ID
- ABW-2021-CF
- Conditions
- Cystic Fibrosis
- Keywords
- Exercise training, High Intensity Interval Training (HIIT), Moderate Intensity Continuous Training (MICT), Exercise capacity, Peak Oxygen uptake (VO2peak), Body-composition, Subjective appetite and satiety ratings, Appetite regulating hormones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of KielUniversity, hospital or other
- Collaborators
- Fachklinik Satteldüne der DRV Nord, University of Kiel, Arbeitsbereich Sportmedizin und Trainingswissenschaften, Strandklinik St. Peter-Ording
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 2 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training (A) | Experimental | Other: High Intensity Interval Training (HIIT)Exercise training with intermittent bouts of high intensity |
| Moderate Intensity Continous Training (B) | Experimental | Other: Moderate Continuous Intensity Training (MICT)Exercise training with constant workload |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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%,
Key exclusion criteria (4 listed)
- Severe pulmonary exacerbation,
- cor pulmonale,
- musculoskeletal discomfort that makes a regular exercise training impossible,
- untreated CF-related diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Interval Training (HIIT)High Intensity Interval Training | Other | High Intensity Interval Training (A) |
| Moderate Continuous Intensity Training (MICT)Moderate Intensity Continuous Training | Other | Moderate Intensity Continous Training (B) |
Primary outcome
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
change in Peak Workload
Time frame: at baseline and after 4 weeks of exercise training program
measured with peak Workload in percent predicted
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
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
3 secondary outcomes
change in Forced Expiratory Volume in 1 second
Time frame: at baseline and after 4 weeks of exercise training program
change in Health related quality of life
Time frame: at baseline and six and twelve months after completion of exercise training program
appetite control - subjective feeling of hunger
Time frame: at baseline and after 4 weeks of exercise training program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anja Bosy-Westhphal, Prof, PhD, MD study chair
Insitute of Human Nutrition, University of Kiel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Training (HIIT) and Moderate Continuous Intensity Training (MICT) in people with Cystic Fibrosis, run by University of Kiel at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Peak Oxygen Uptake (time frame: at baseline and after 4 weeks of exercise training program). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.