Back to resultsEffects of Training Intensity on Physical Fitness and Body Composition in Cystic Fibrosis
Primary Purpose
Cystic Fibrosis
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
High Intensity Interval Training (HIIT)
Moderate Continuous Intensity Training (MICT)
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis focused on measuring Exercise training, High Intensity Interval Training (HIIT), Moderate Intensity Continuous Training (MICT), Exercise capacity, Peak Oxygen uptake (VO2peak), Body-composition, Subjective appetite and satiety ratings, Appetite regulating hormones, Health related quality of life, Habitual physical activity, ad libitum energy intake
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
Sites / Locations
- Fachklink Satteldüne der DRV NordRecruiting
- Strandklinik St. Peter-Ording
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
High Intensity Interval Training (A)
Moderate Intensity Continous Training (B)
Arm Description
Exercise training with intermittent bouts of high intensity
Exercise training with constant workload
Outcomes
Primary Outcome Measures
change in Peak Oxygen Uptake
measured with peak Oxygen uptake (VO2) in percent predicted
change in Peak Workload
measured with peak Workload in percent predicted
change body fat mass index
measured with body fat mass index (FMI) in kg / m*2
change in Body fat free mass index
measured with fat free body mass index (FFMI) in kg / m*2
Secondary Outcome Measures
change in Forced Expiratory Volume in 1 second
measured with Forced Expiratory Volume in 1 second (FEV1) in percent predicted
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.
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.
Full Information
NCT ID
NCT05140967
First Posted
October 29, 2021
Last Updated
May 9, 2023
Sponsor
University of Kiel
Collaborators
Fachklinik Satteldüne der DRV Nord, University of Kiel, Arbeitsbereich Sportmedizin und Trainingswissenschaften, Strandklinik St. Peter-Ording
1. Study Identification
Unique Protocol Identification Number
NCT05140967
Brief Title
Effects of Training Intensity on Physical Fitness and Body Composition in Cystic Fibrosis
Official Title
Effects of Endurance Training Intensity on Exercise Capacity, Body Composition, and Appetite Regulation in Cystic Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kiel
Collaborators
Fachklinik Satteldüne der DRV Nord, University of Kiel, Arbeitsbereich Sportmedizin und Trainingswissenschaften, Strandklinik St. Peter-Ording
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Exercise training, High Intensity Interval Training (HIIT), Moderate Intensity Continuous Training (MICT), Exercise capacity, Peak Oxygen uptake (VO2peak), Body-composition, Subjective appetite and satiety ratings, Appetite regulating hormones, Health related quality of life, Habitual physical activity, ad libitum energy intake
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High Intensity Interval Training (A)
Arm Type
Experimental
Arm Description
Exercise training with intermittent bouts of high intensity
Arm Title
Moderate Intensity Continous Training (B)
Arm Type
Experimental
Arm Description
Exercise training with constant workload
Intervention Type
Other
Intervention Name(s)
High Intensity Interval Training (HIIT)
Intervention Description
High Intensity Interval Training
Intervention Type
Other
Intervention Name(s)
Moderate Continuous Intensity Training (MICT)
Intervention Description
Moderate Intensity Continuous Training
Primary Outcome Measure Information:
Title
change in Peak Oxygen Uptake
Description
measured with peak Oxygen uptake (VO2) in percent predicted
Time Frame
at baseline and after 4 weeks of exercise training program
Title
change in Peak Workload
Description
measured with peak Workload in percent predicted
Time Frame
at baseline and after 4 weeks of exercise training program
Title
change body fat mass index
Description
measured with body fat mass index (FMI) in kg / m*2
Time Frame
at baseline and after 4 weeks of exercise training program
Title
change in Body fat free mass index
Description
measured with fat free body mass index (FFMI) in kg / m*2
Time Frame
at baseline and after 4 weeks of exercise training program
Secondary Outcome Measure Information:
Title
change in Forced Expiratory Volume in 1 second
Description
measured with Forced Expiratory Volume in 1 second (FEV1) in percent predicted
Time Frame
at baseline and after 4 weeks of exercise training program
Title
change in Health related quality of life
Description
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.
Time Frame
at baseline and six and twelve months after completion of exercise training program
Title
appetite control - subjective feeling of hunger
Description
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.
Time Frame
at baseline and after 4 weeks of exercise training program
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anja Bosy-Westphal, Prof, PhD, MD
Phone
+494318805674
Email
abosyw@nutrition.uni-kiel.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anja Bosy-Westhphal, Prof, PhD, MD
Organizational Affiliation
Insitute of Human Nutrition, University of Kiel
Official's Role
Study Chair
Facility Information:
Facility Name
Fachklink Satteldüne der DRV Nord
City
Nebel / Amrum
State/Province
Schleswig-Holstein
ZIP/Postal Code
25946
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Falkenberg, MD
Phone
+4946823400
Email
christian.falkenberg@drv-nord.de
Facility Name
Strandklinik St. Peter-Ording
City
Saint Peter-Ording
State/Province
Schleswig-Holstein
ZIP/Postal Code
25826
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Dewey, MD
Phone
+494863 7061-151
Email
s.dewey@strandklinik-spo.de
12. IPD Sharing Statement
Learn more about this trial
Effects of Training Intensity on Physical Fitness and Body Composition in Cystic Fibrosis
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