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

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Other: High Intensity Interval Training (HIIT); Other: Moderate Continuous Intensity Training (MICT)

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Schleswig-Holstein
    • Nebel / Amrum, Schleswig-Holstein, Germany, 25946
      • Fachklink Satteldüne der DRV Nord
    • St. Peter-Ording, Schleswig-Holstein, Germany, 25826
      • Strandklinik St. Peter-Ording

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Kiel
• Collaborators: Fachklinik Satteldüne der DRV Nord; University of Kiel, Arbeitsbereich Sportmedizin und Trainingswissenschaften; Strandklinik St. Peter-Ording
• Investigators: Study Chair: Anja Bosy-Westhphal, Prof, PhD, MD, Insitute of Human Nutrition, University of Kiel

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: October 29, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (Actual): December 2, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Exercise training; Exercise capacity; Health related quality of life; Body-composition; Appetite regulating hormones; ad libitum energy intake; Habitual physical activity; High Intensity Interval Training (HIIT); Moderate Intensity Continuous Training (MICT); Peak Oxygen uptake (VO2peak); Subjective appetite and satiety ratings
• Additional Relevant MeSH Terms: Pathologic Processes; Genetic Diseases, Inborn; Respiratory Tract Diseases; Digestive System Diseases; Lung Diseases; Infant, Newborn, Diseases; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: ABW-2021-CF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No