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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05140967
• Other study ID #: ABW-2021-CF
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 15, 2021
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: University of Kiel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Other:
• High Intensity Interval Training (HIIT)
High Intensity Interval Training
• Moderate Continuous Intensity Training (MICT)
Moderate Intensity Continuous Training

Locations

Country	Name	City	State
Germany	Fachklink Satteldüne der DRV Nord	Nebel / Amrum	Schleswig-Holstein
Germany	Strandklinik St. Peter-Ording	Saint Peter-Ording	Schleswig-Holstein

Sponsors (4)

Lead Sponsor	Collaborator
University of Kiel	Fachklinik Satteldüne der DRV Nord, Strandklinik St. Peter-Ording, University of Kiel, Arbeitsbereich Sportmedizin und Trainingswissenschaften

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in Peak Oxygen Uptake	measured with peak Oxygen uptake (VO2) in percent predicted	at baseline and after 4 weeks of exercise training program
Primary	change in Peak Workload	measured with peak Workload in percent predicted	at baseline and after 4 weeks of exercise training program
Primary	change body fat mass index	measured with body fat mass index (FMI) in kg / m*2	at baseline and after 4 weeks of exercise training program
Primary	change in Body fat free mass index	measured with fat free body mass index (FFMI) in kg / m*2	at baseline and after 4 weeks of exercise training program
Secondary	change in Forced Expiratory Volume in 1 second	measured with Forced Expiratory Volume in 1 second (FEV1) in percent predicted	at baseline and after 4 weeks of exercise training program
Secondary	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.	at baseline and six and twelve months after completion of exercise training program
Secondary	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.	at baseline and after 4 weeks of exercise training program