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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05140967

Enrollment

Registered

2021-12-02

Start date

2021-10-15

Completion date

2024-12-31

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

OTHERHigh Intensity Interval Training (HIIT)

High Intensity Interval Training

OTHERModerate Continuous Intensity Training (MICT)

Moderate Intensity Continuous Training

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
change in Peak Oxygen Uptake	at baseline and after 4 weeks of exercise training program	measured with peak Oxygen uptake (VO2) in percent predicted
change in Peak Workload	at baseline and after 4 weeks of exercise training program	measured with peak Workload in percent predicted
change body fat mass index	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	at baseline and after 4 weeks of exercise training program	measured with fat free body mass index (FFMI) in kg / m\*2

Secondary

Measure	Time frame	Description
change in Health related quality of life	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.
appetite control - subjective feeling of hunger	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.
change in Forced Expiratory Volume in 1 second	at baseline and after 4 weeks of exercise training program	measured with Forced Expiratory Volume in 1 second (FEV1) in percent predicted

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026