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Clinical Trials/NCT05140967
NCT05140967
Completed
Not Applicable

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

University of Kiel2 sites in 1 country70 target enrollmentOctober 15, 2021
ConditionsCystic Fibrosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cystic Fibrosis
Sponsor
University of Kiel
Enrollment
70
Locations
2
Primary Endpoint
change body fat mass index
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 15, 2021
End Date
December 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Prof. Dr. Dr. Anja Bosy-Westphal

Prof. Dr. Dr. Anja Bosy-Westphal

University of Kiel

Eligibility Criteria

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

Outcomes

Primary Outcomes

change body fat mass index

Time Frame: 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

Time Frame: 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

Time Frame: at baseline and after 4 weeks of exercise training program

measured with peak Oxygen uptake (VO2) in percent predicted

change in Peak Workload

Time Frame: at baseline and after 4 weeks of exercise training program

measured with peak Workload in percent predicted

Secondary Outcomes

  • change in Forced Expiratory Volume in 1 second(at baseline and after 4 weeks of exercise training program)
  • appetite control - subjective feeling of hunger(at baseline and after 4 weeks of exercise training program)
  • change in Health related quality of life(at baseline and six and twelve months after completion of exercise training program)

Study Sites (2)

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