NCT05140967

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2021

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 2, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 17, 2025

Status Verified

February 1, 2025

Enrollment Period

2.2 years

First QC Date

October 29, 2021

Last Update Submit

February 13, 2025

Conditions

Cystic Fibrosis

Keywords

Exercise trainingHigh Intensity Interval Training (HIIT)Moderate Intensity Continuous Training (MICT)Exercise capacityPeak Oxygen uptake (VO2peak)Body-compositionSubjective appetite and satiety ratingsAppetite regulating hormonesHealth related quality of lifeHabitual physical activityad libitum energy intake

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • change in Forced Expiratory Volume in 1 second

    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

  • appetite control - subjective feeling of hunger

    at baseline and after 4 weeks of exercise training program

Study Arms (2)

High Intensity Interval Training (A)

EXPERIMENTAL

Exercise training with intermittent bouts of high intensity

Other: High Intensity Interval Training (HIIT)

Moderate Intensity Continous Training (B)

EXPERIMENTAL

Exercise training with constant workload

Other: Moderate Continuous Intensity Training (MICT)

Interventions

High Intensity Interval Training (HIIT)OTHER

High Intensity Interval Training

High Intensity Interval Training (A)
Moderate Continuous Intensity Training (MICT)OTHER

Moderate Intensity Continuous Training

Moderate Intensity Continous Training (B)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Severe pulmonary exacerbation,
  • cor pulmonale,
  • musculoskeletal discomfort that makes a regular exercise training impossible,
  • untreated CF-related diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fachklink Satteldüne der DRV Nord

Nebel / Amrum, Schleswig-Holstein, 25946, Germany

Location

Strandklinik St. Peter-Ording

Sankt Peter-Ording, Schleswig-Holstein, 25826, Germany

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Anja Bosy-Westhphal, Prof, PhD, MD

    Insitute of Human Nutrition, University of Kiel

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Dr. Anja Bosy-Westphal

Study Record Dates

First Submitted

October 29, 2021

First Posted

December 2, 2021

Study Start

October 15, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

February 17, 2025

Record last verified: 2025-02

Locations

DE(2)