Clinical trial NCT05140967: Effects of Training Intensity on Physical Fitness and Body Composition in Cystic Fibrosis
Official title: Effects of Endurance Training Intensity on Exercise Capacity, Body Composition, and Appetite Regulation in Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Health related quality of life
Habitual physical activity
ad libitum energy intake
Lead sponsor: University of Kiel
Sponsor class: OTHER
Collaborators: name: Fachklinik Satteldüne der DRV Nord
name: University of Kiel, Arbeitsbereich Sportmedizin und Trainingswissenschaften
name: Strandklinik St. Peter-Ording
First posted: 2021-12-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: change in Peak Oxygen Uptake
timeFrame: at baseline and after 4 weeks of exercise training program
measure: change in Peak Workload
timeFrame: at baseline and after 4 weeks of exercise training program
measure: change body fat mass index
timeFrame: at baseline and after 4 weeks of exercise training program
measure: change in Body fat free mass index
timeFrame: at baseline and after 4 weeks of exercise training program
Secondary outcomes:
measure: change in Forced Expiratory Volume in 1 second
timeFrame: at baseline and after 4 weeks of exercise training program
measure: change in Health related quality of life
timeFrame: at baseline and six and twelve months after completion of exercise training program
measure: appetite control - subjective feeling of hunger
timeFrame: at baseline and after 4 weeks of exercise training program
Other outcomes:
Locations:
city: Nebel / Amrum
country: Germany
facility: Fachklink Satteldüne der DRV Nord
state: Schleswig-Holstein
city: St. Peter-Ording
country: Germany
facility: Strandklinik St. Peter-Ording
state: Schleswig-Holstein
Study officials:
affiliation: Insitute of Human Nutrition, University of Kiel
name: Anja Bosy-Westhphal, Prof, PhD, MD
role: STUDY_CHAIR
References: