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

February 13, 2025 updated by: Prof. Dr. Dr. Anja Bosy-Westphal, University of Kiel

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
at baseline and after 4 weeks of exercise training program
change in Peak Workload
Time Frame: at baseline and after 4 weeks of exercise training program
measured with peak Workload in percent predicted
at baseline and after 4 weeks of exercise training program
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
at baseline and after 4 weeks of exercise training program
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
at baseline and after 4 weeks of exercise training program

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change in Forced Expiratory Volume in 1 second
Time Frame: at baseline and after 4 weeks of exercise training program
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
Time Frame: at baseline and six and twelve months after completion of exercise training program
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
Time Frame: at baseline and after 4 weeks of exercise training program
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Kiel

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fachklinik Satteldüne der DRV Nord
University of Kiel, Arbeitsbereich Sportmedizin und Trainingswissenschaften
Strandklinik St. Peter-Ording

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Anja Bosy-Westhphal, Prof, PhD, MD, Insitute of Human Nutrition, University of Kiel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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