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

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Other: High Intensity Interval Training (HIIT); Other: Moderate Continuous Intensity Training (MICT)

• Registration Number: NCT05140967
• Lead Sponsor: University of Kiel

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-15
• Study First Submitted: 2021-10-29
• Study First Submitted QC: 2021-12-01
• Study First Posted: 2021-12-02
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Intensity Interval Training (A)	High Intensity Interval Training (HIIT)	Exercise training with intermittent bouts of high intensity
Moderate Intensity Continous Training (B)	Moderate Continuous Intensity Training (MICT)	Exercise training with constant workload

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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.
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
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.

Trial Locations

Locations (2)

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

Strandklinik St. Peter-Ording; 🇩🇪 St. Peter-Ording, Schleswig-Holstein, Germany