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

NCT ID: NCT05140967

Last Updated: 2025-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-15

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cystic Fibrosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High Intensity Interval Training (A)

Exercise training with intermittent bouts of high intensity

Group Type EXPERIMENTAL

High Intensity Interval Training (HIIT)

Intervention Type OTHER

High Intensity Interval Training

Moderate Intensity Continous Training (B)

Exercise training with constant workload

Group Type EXPERIMENTAL

Moderate Continuous Intensity Training (MICT)

Intervention Type OTHER

Moderate Intensity Continuous Training

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

High Intensity Interval Training (HIIT)

High Intensity Interval Training

Intervention Type OTHER

Moderate Continuous Intensity Training (MICT)

Moderate Intensity Continuous Training

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fachklinik Satteldüne der DRV Nord

UNKNOWN

Sponsor Role collaborator

University of Kiel, Arbeitsbereich Sportmedizin und Trainingswissenschaften

UNKNOWN

Sponsor Role collaborator

Strandklinik St. Peter-Ording

UNKNOWN

Sponsor Role collaborator

University of Kiel

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Prof. Dr. Dr. Anja Bosy-Westphal

Prof. Dr. Dr. Anja Bosy-Westphal

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anja Bosy-Westhphal, Prof, PhD, MD

Role: STUDY_CHAIR

Insitute of Human Nutrition, University of Kiel

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fachklink Satteldüne der DRV Nord

Nebel / Amrum, Schleswig-Holstein, Germany

Site Status

Strandklinik St. Peter-Ording

Sankt Peter-Ording, Schleswig-Holstein, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ABW-2021-CF

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A CFit Study - Baseline
NCT03234387 TERMINATED
Do More, B'More, Live Fit
NCT03109912 COMPLETED NA