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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Other: High Intensity Interval Training (HIIT)
* Other: Moderate Continuous Intensity Training (MICT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Intensity Interval Training (A)<br>Exercise training with intermittent bouts of high intensity | Other: High Intensity Interval Training (HIIT)<br>* High Intensity Interval Training<br>|
| Experimental: Moderate Intensity Continous Training (B)<br>Exercise training with constant workload | Other: Moderate Continuous Intensity Training (MICT)<br>* Moderate Intensity Continuous Training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Peak Oxygen Uptake | measured with peak Oxygen uptake (VO2) in percent predicted | at baseline and after 4 weeks of exercise training program | 
| change in Peak Workload | measured with peak Workload in percent predicted | at baseline and after 4 weeks of exercise training program | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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