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

Sponsor

University of Kiel (Other)

Overall Status

Recruiting

CT.gov ID

NCT05140967

Collaborator

Fachklinik Satteldüne der DRV Nord (Other), University of Kiel, Arbeitsbereich Sportmedizin und Trainingswissenschaften (Other), Strandklinik St. Peter-Ording (Other)

Enrollment

Locations

Arms

34.6

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis	Other: High Intensity Interval Training (HIIT) Other: Moderate Continuous Intensity Training (MICT)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 15, 2021

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High Intensity Interval Training (A) Exercise training with intermittent bouts of high intensity	Other: High Intensity Interval Training (HIIT) High Intensity Interval Training
Experimental: Moderate Intensity Continous Training (B) Exercise training with constant workload	Other: Moderate Continuous Intensity Training (MICT) Moderate Intensity Continuous Training

Arm

Intervention/Treatment

Experimental: High Intensity Interval Training (A)

Exercise training with intermittent bouts of high intensity

Other: High Intensity Interval Training (HIIT)

High Intensity Interval Training

Experimental: Moderate Intensity Continous Training (B)

Exercise training with constant workload

Other: Moderate Continuous Intensity Training (MICT)

Moderate Intensity Continuous Training

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fachklink Satteldüne der DRV Nord	Nebel / Amrum	Schleswig-Holstein	Germany	25946
2	Strandklinik St. Peter-Ording	Saint Peter-Ording	Schleswig-Holstein	Germany	25826