Cystic FibrosisNCT03518697
Effects of an Individualized Exercise Program on Health-related and Skill/Performance-related fitness in CF.
A study testing exercise program in people with Cystic Fibrosis, run by University Hospital, Essen at 3 sites in Germany.
Trial summary
The aim of this study is to evaluate the effects of a partially supervised exercise program on different aspects of physical fitness, despite VO2peak, lung function, quality of life and sleep quality in children, adolescents and adults with Cystic Fibrosis. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesGermany
- Study dates
- 10 Sep 2014to 10 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Confirmed diagnosis of CF
- Informed consent
Who cannot join
- Cardiac arrhythmias with exercise
- Patients with cor pulmonale
- Colonization with Burkholderia cenocepacia, Methicillin-resistant Staphylococcus aureus (MRSA) and multidrug-resistant Gram-negative (MRGN) pathogens (3 and 4 MRGN)
- Patients with untreated diabetes
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
St. Josef-Hospital im Katholischen Klinikum Bochum, Klinik für Kinder und Jugendmedizin, Alexandrinenstrasse 5
Bochum, 44791
Universitätsklinikum Essen, Klinik für Kinderheilkunde III, Pädiatrische Pneumologie und Schlafmedizin, Hufelandstr. 55
Essen, 45147
Ruhrlandklinik Essen, Westdeutsches Lungenzentrum am Universitätsklinikum Essen, Tuschener Weg 40
Essen, 45239
About this study
Official title: Effects of an Individualized and Partially Supervised Exercise Program on Parameters of Physical Fitness, Lung Function, Habitual Physical Activity in Daily Life and Quality of Life in Children, Adolescents and Adults With Cystic Fibrosis.
The aim of this study is to evaluate the effects of a partially supervised exercise program on different aspects of physical fitness, despite VO2peak, lung function, quality of life and sleep quality in children, adolescents and adults with Cystic Fibrosis.
Read the detailed description
There is growing consensus that exercise in subjects with cystic fibrosis (CF) may yield improvements in measures of physical fitness, lung function and quality of life. In most of the training studies exercise capacity was expressed as peak oxygen uptake (VO2peak), which has been found to be one of the best predictors of survival in subjects with CF. Those subjects with a higher VO2peak related to age and gender specific predicted VO2peak (%pred) have a better prognosis than those with a lower VO2peak (%pred). VO2peak represents the cardiorespiratory endurance is one aspect of physical fitness.
Physical fitness may be subdivided into health-related fitness and skill/performance-related fitness. Cardiorespiratory endurance, muscular strength and endurance, body composition and flexibility are often referred to as health-related fitness. Balance, coordination, speed, agility and power are often described as skill/performance related fitness, reflecting the performance aspect of physical fitness. It has been shown, that children and adolescents with a lower skill / performance related fitness are less physical active than those with a higher skill/performance related fitness. This may lead to physically inactive in daily life, less motivation to take part in organized sport and as a consequence to a lower VO2peak.
The primary outcome parameters of this study is to evaluate the effects 12-month partially supervised exercise program on 1) health-related fitness (endurance expressed as maximal workload, muscular strength) and skill / performance related fitness (balance, power, agility)and 2) habitual physical activity (steps / day; intensity expressed in METs) in a large group of subjects with CF. Secondary outcome parameters include forced exspiratory volume in 1 second (FEV1), sleep-wake cycle, quality of sleep, quality of life, and exercise related barriers and barrier management in physical exercise.
In total 100 subjects with CF 6 year and older will be included. Habitual physical activity and sleep will be recorded by accelerometer before subjects enter the exercise program, and after 6 month and after 12 month. Check-ups, lung function measurement and testing of physical fitness will be performed at baseline, after 6 and 12 month.
During the first six month the participants will be contacted by telephone every two weeks. After six month individual counseling by telephone will be stopped.
The exercise program is planned as a "low-threshold exercise program "with low barriers to participate. Participants will be asked about their interests and preferences of sports activities to conceive the exercise program together with the participants. Along with counseling participants will be motivated to increase physical activity by at least 10-20 minutes per day.
The investigators expect to gain another insight into different aspects of physical fitness, habitual physical activity and sleep from the results of this study. Up to know, there are only a few trails investigated different aspects of physical fitness that means balance, flexibility, power as parameters of health-related fitness and skill/performance-related fitness. The investigators assume that participants with higher values are more physical active than those with lower values and these participants will have a higher cardiorespiratory endurance.
- Conditions
- Cystic Fibrosis
- Being tested
- exercise program
- Keywords
- Exercise, Physical fitness, Physical activity, Accelerometer, Sleep
- Medical subject headings
- Cystic Fibrosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise programBehavioural
The exercise program is planned as a "low-threshold exercise program "with low barriers to participate. Patients will be asked about their interests and preferences of sports activities to conceive the exercise program together with the patients.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | 1. First 6 months supervised exercise program with telephone contact every two weeks
2. Second 6 months exercise program without telephone contact
3. Patients should increase habitual daily physical activity for 10-20 minutes per day 5 times per week
4. Activities were chosen according to the preferences, interests, and severity of disease of the patients
5. Activites should improve endurance, strength, coordination and flexibility
6. Every three month regular vistit at the CF care center (medical examination, lung function, exercise testing, counselling and evaluation of activities by acceleometry and if appropirate adaption of exercise program) Receives: Behavioral: exercise program |
| Control-Group | No intervention | 1. 12 months usual routine care and habitual exercise in daily life. 2. At start and after 12 month assessment of habitual exercise with accelerometry (Actigraph GTX3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of habitual physical activity in hours/day
Measurement of the time of physical activity in hours/day by accelerometry (ActiGraph GT3X, Penascola, USA)
Measured: at baseline, after 6 and 12 month
Secondary outcomes (26)
Change of the quality of life in Cystic Fibrosis
Measurement of the quality of life by the Cystic Fibrosis Questionnaire Revised (CFQ-R, Quality of life domains: Physical, role/school, vitality, emotion, social, body image, eating, treatment burden, health perceptions. Symptom scales: Weight, respiratory, and digestion)
Measured: at baseline, after 6 and 12 month
Change of the duration of sleep in hours
Measurement of the duration of sleep in hours by accelerometry (ActiGraph GT3X, Penascola, USA)
Measured: at baseline, after 6 and 12 month
Change of the quality of sleep in percent
Measurement of the quality of sleep in percent by accelerometry (ActiGraph GT3X, Penascola, USA)
Measured: at baseline, after 6 and 12 month
Determination of the exercise related barriers and barrier management in physical exercise
specific questionnaire (Barrieren und Barrierenmanagementim Prozess der Sportteilnahme, Krämer and Fuchs, Zeitschrift für Gesundheitspsychologie, 18(4), 170-182, 2010)
Measured: at baseline
Change of habitual physical activity in steps/day
Measurement of the number of steps/day by accelerometry (ActiGraph GT3X, Penascola, USA)
Measured: at baseline, after 6 and 12 month
Change of habitual physical activity spend in light intensity (≤ 3METS) in minutes
Measurement of the time of habitual physical activity spend in light intensity (≤ 3METS) in minutes by accelerometry (ActiGraph GT3X, Penascola, USA)
Measured: at baseline, after 6 and 12 month
Change of habitual physical activity spend in moderate to vigorous intensity (3 to 5.9 METS) in minutes by accelerometry (ActiGraph GT3X, Penascola, USA)
Measurement of the time of habitual physical activity spend in moderate to vigorous intensity (3 to 5.9 METS) in minutes by accelerometry (ActiGraph GT3X, Penascola, USA)
Measured: at baseline, after 6 and 12 month
Change of habitual physical activity spend in vigorous intensity (6 to 8.99 METS) in minutes by accelerometry (ActiGraph GT3X, Penascola, USA)
Measurement of the time of habitual physical activity spend in vigorous intensity (6 to 8.99 METS) in minutes by accelerometry (ActiGraph GT3X, Penascola, USA)
Measured: at baseline, after 6 and 12 month
Change of habitual physical activity spend in hard intensity (≥ 9 METS) in minutes by accelerometry (ActiGraph GT3X, Penascola, USA)
Measurement of the time of habitual physical activity spend in hard intensity (≥ 9 METS) in minutes by accelerometry (ActiGraph GT3X, Penascola, USA)
Measured: at baseline, after 6 and 12 month
Change of maximal exercise capacity expressed as heart rate
Measurement of heart rate in b/min by cycle ergometry (Ergoselect 100p, Ergoline, Bitz, Germany)
Measured: at baseline, after 6 and 12 month
Change of maximal exercise capacity expressed as heart rate reserve in percent
Measurement of heart rate reserve in percent by cycle ergometry (Ergoselect 100p, Ergoline, Bitz, Germany)
Measured: at baseline, after 6 and 12 month
Change of maximal exercise capacity expressed as workload in Watt
Measurement of workload in Watt by cycle ergometry (Ergoselect 100p, Ergoline, Bitz, Germany)
Measured: at baseline, after 6 and 12 month
Change of maximal exercise capacity expressed as workload in Watt / kg bodyweight
Measurement of workload in Watt / kg bodyweight by cycle ergometry (Ergoselect 100p, Ergoline, Bitz, Germany)
Measured: at baseline, after 6 and 12 month
Change of maximal exercise capacity expressed as perceived exertion (Borg CR10 Scale) in number of level of exertion
Measurement of the Borg questionnaire (Borg CR10 Scale)
Measured: at baseline, after 6 and 12 month
Change of skill / performance related fitness expressed as push-ups in number of repetition in 40 sec.
Measurement of push-ups in number of repetition in 40 sec. with the German motor test (Deutscher Motorik Test, Forschungszentrum für den Schulsport und den Sport von Kindern und Jugendlichen, Karlsruhe, Germany) in children and adolescents aged 6-18 years
Measured: at baseline, after 6 and 12 month
Change of skill / performance related fitness expressed as standing broad jump in cm in children and adolescents
Measurement of standing broad jump in cm with the German motor test (Deutscher Motorik Test, Forschungszentrum für den Schulsport und den Sport von Kindern und Jugendlichen, Karlsruhe, Germany) aged 6-18 years
Measured: at baseline, after 6 and 12 month
Change of skill / performance related fitness expressed as sit-up in number of repetition in 40 sec.
Measurement of sit-ups in number of repetition in 40 sec. with the German motor test (Deutscher Motorik Test, Forschungszentrum für den Schulsport und den Sport von Kindern und Jugendlichen, Karlsruhe, Germany) aged 6-18 years
Measured: at baseline, after 6 and 12 month
Change of skill / performance related fitness expressed as balancing backwards number in steps on a wooden beam 6 cm wide and 3 meters long
Measurement of balancing backwards number in steps on a wooden beam 6 cm wide and 3 meters long with the German motor test (Deutscher Motorik Test, Forschungszentrum für den Schulsport und den Sport von Kindern und Jugendlichen, Karlsruhe, Germany) aged 6-18 years
Measured: at baseline, after 6 and 12 month
Change of skill / performance related fitness expressed as jump sideways in number of repetition in 15 sec.
Measurement of balancing backwards number in jump sideways in number of repetition in 15 sec. with the German motor test (Deutscher Motorik Test, Forschungszentrum für den Schulsport und den Sport von Kindern und Jugendlichen, Karlsruhe, Germany) aged 6-18 years
Measured: at baseline, after 6 and 12 month
Change of skill / performance related fitness expressed as flexibility in cm in children and adolescents
Measurement of flexibility in cm with the German motor test (Deutscher Motorik Test, Forschungszentrum für den Schulsport und den Sport von Kindern und Jugendlichen, Karlsruhe, Germany) aged 6-18 years
Measured: at baseline, after 6 and 12 month
Change of skill / performance related fitness expressed as one leg stand in sec.
Measurement of one leg stand in sec. as included in the TFR (Test Fitness Rekrutierung, Bundesamt für Sport BASPO, Magglingen, Schweiz) in adults
Measured: at baseline, after 6 and 12 month
Change of skill / performance related fitness expressed as standing broad jump in cm in adults
Measurement of standing broad jump in cm as included in the TFR (Test Fitness Rekrutierung, Bundesamt für Sport BASPO, Magglingen, Schweiz) in adults
Measured: at baseline, after 6 and 12 month
Change of skill / performance related fitness expressed as trunk power in sec.
Measurement of trunk power in sec. as included in the TFR (Test Fitness Rekrutierung, Bundesamt für Sport BASPO, Magglingen, Schweiz) in adults
Measured: at baseline, after 6 and 12 month
Change of skill / performance related fitness expressed as flexibility in cm in adults
Measurement of flexibility in cm as included in the basic motor diagnostics (Motorische Basisdiagnostik, Hrsg. Bös/Wydra/Karisch, 1992) in adults
Measured: at baseline, after 6 and 12 month
Change of skill / performance related fitness expressed as circling motion in number of complete performed circles
Measurement of circling motion in number of complete performed circles as included in the basic motor diagnostics (Motorische Basisdiagnostik, Hrsg. Bös/Wydra/Karisch, 1992) in adults
Measured: at baseline, after 6 and 12 month
Change of skill / performance related fitness expressed as the time of hip extension in sec.
Measurement of the time of hip extension in sec. as included in the basic motor diagnostics (Motorische Basisdiagnostik, Hrsg. Bös/Wydra/Karisch, 1992) in adults
Measured: at baseline, after 6 and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start10 Sep 2014
- Primary completion10 Aug 2018
- Study completion10 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Florian Stehling, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518697
- Sponsor's protocol ID
- 14-6117-BO
- Status last verified
- Jan 2019
- First submitted
- 26 Mar 2018
- Last updated
- 3 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dietz-Terjung S, Gruber W, Sutharsan S, Taube C, Olivier M, Mellies U, Koerner-Rettberg C, Dillenhofer S, Stehling F, Welsner M. Association between habitual physical activity (HPA) and sleep quality in patients with cystic fibrosis. Sleep Breath. 2021 Jun;25(2):609-615. doi: 10.1007/s11325-020-02130-0. Epub 2020 Jul 14.
PubMed 32661789
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Individualized and Partially Supervised Exercise Program on Parameters of Physical Fitness, Lung Function, Habitual Physical Activity in Daily Life and Quality of Life in Children, Adolescents and Adults With Cystic Fibrosis.
- ClinicalTrials.gov ID
- NCT03518697
- Acronym / sponsor ID
- 14-6117-BO
- Conditions
- Cystic Fibrosis
- Keywords
- Exercise, Physical fitness, Physical activity, Accelerometer, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 10 Sep 2014 (actual)
- Primary completion
- 10 Aug 2018 (actual)
- Study completion
- 10 Aug 2018 (actual)
- First posted
- 8 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the effects of a partially supervised exercise program on different aspects of physical fitness, despite VO2peak, lung function, quality of life and sleep quality in children, adolescents and adults with Cystic Fibrosis.
Detailed description
There is growing consensus that exercise in subjects with cystic fibrosis (CF) may yield improvements in measures of physical fitness, lung function and quality of life. In most of the training studies exercise capacity was expressed as peak oxygen uptake (VO2peak), which has been found to be one of the best predictors of survival in subjects with CF. Those subjects with a higher VO2peak related to age and gender specific predicted VO2peak (%pred) have a better prognosis than those with a lower VO2peak (%pred). VO2peak represents the cardiorespiratory endurance is one aspect of physical fitness.
Physical fitness may be subdivided into health-related fitness and skill/performance-related fitness. Cardiorespiratory endurance, muscular strength and endurance, body composition and flexibility are often referred to as health-related fitness. Balance, coordination, speed, agility and power are often described as skill/performance related fitness, reflecting the performance aspect of physical fitness. It has been shown, that children and adolescents with a lower skill / performance related fitness are less physical active than those with a higher skill/performance related fitness. This may lead to physically inactive in daily life, less motivation to take part in organized sport and as a consequence to a lower VO2peak.
The primary outcome parameters of this study is to evaluate the effects 12-month partially supervised exercise program on 1) health-related fitness (endurance expressed as maximal workload, muscular strength) and skill / performance related fitness (balance, power, agility)and 2) habitual physical activity (steps / day; intensity expressed in METs) in a large group of subjects with CF. Secondary outcome parameters include forced exspiratory volume in 1 second (FEV1), sleep-wake cycle, quality of sleep, quality of life, and exercise related barriers and barrier management in physical exercise.
In total 100 subjects with CF 6 year and older will be included. Habitual physical activity and sleep will be recorded by accelerometer before subjects enter the exercise program, and after 6 month and after 12 month. Check-ups, lung function measurement and testing of physical fitness will be performed at baseline, after 6 and 12 month.
During the first six month the participants will be contacted by telephone every two weeks. After six month individual counseling by telephone will be stopped.
The exercise program is planned as a "low-threshold exercise program "with low barriers to participate. Participants will be asked about their interests and preferences of sports activities to conceive the exercise program together with the participants. Along with counseling participants will be motivated to increase physical activity by at least 10-20 minutes per day.
The investigators expect to gain another insight into different aspects of physical fitness, habitual physical activity and sleep from the results of this study. Up to know, there are only a few trails investigated different aspects of physical fitness that means balance, flexibility, power as parameters of health-related fitness and skill/performance-related fitness. The investigators assume that participants with higher values are more physical active than those with lower values and these participants will have a higher cardiorespiratory endurance.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Behavioral: exercise program1. First 6 months supervised exercise program with telephone contact every two weeks 2. Second 6 months exercise program without telephone contact 3. Patients should increase habitual daily physical activity for 10-20 minutes per day 5 times per week 4. Activities were chosen according to the preferences, interests, and severity of disease of the patients 5. Activites should improve endurance, strength, coordination and flexibility 6. Every three month regular vistit at the CF care center (medical examination, lung function, exercise testing, counselling and evaluation of activities by acceleometry and if appropirate adaption of exercise program) |
| Control-Group | No intervention | –1. 12 months usual routine care and habitual exercise in daily life. 2. At start and after 12 month assessment of habitual exercise with accelerometry (Actigraph GTX3) |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed diagnosis of CF
- Informed consent
Key exclusion criteria (4 listed)
- Cardiac arrhythmias with exercise
- Patients with cor pulmonale
- Colonization with Burkholderia cenocepacia, Methicillin-resistant Staphylococcus aureus (MRSA) and multidrug-resistant Gram-negative (MRGN) pathogens (3 and 4 MRGN)
- Patients with untreated diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise programThe exercise program is planned as a "low-threshold exercise program "with low barriers to participate. Patients will be asked about their interests and preferences of sports activities to conceive the exercise program together with the patients. | Behavioural | Exercise Group |
Primary outcome
Change of habitual physical activity in hours/day
Time frame: at baseline, after 6 and 12 month
Measurement of the time of physical activity in hours/day by accelerometry (ActiGraph GT3X, Penascola, USA)
26 secondary outcomes
Change of the quality of life in Cystic Fibrosis
Time frame: at baseline, after 6 and 12 month
Change of the duration of sleep in hours
Time frame: at baseline, after 6 and 12 month
Change of the quality of sleep in percent
Time frame: at baseline, after 6 and 12 month
Determination of the exercise related barriers and barrier management in physical exercise
Time frame: at baseline
Change of habitual physical activity in steps/day
Time frame: at baseline, after 6 and 12 month
Change of habitual physical activity spend in light intensity (≤ 3METS) in minutes
Time frame: at baseline, after 6 and 12 month
Change of habitual physical activity spend in moderate to vigorous intensity (3 to 5.9 METS) in minutes by accelerometry (ActiGraph GT3X, Penascola, USA)
Time frame: at baseline, after 6 and 12 month
Change of habitual physical activity spend in vigorous intensity (6 to 8.99 METS) in minutes by accelerometry (ActiGraph GT3X, Penascola, USA)
Time frame: at baseline, after 6 and 12 month
Change of habitual physical activity spend in hard intensity (≥ 9 METS) in minutes by accelerometry (ActiGraph GT3X, Penascola, USA)
Time frame: at baseline, after 6 and 12 month
Change of maximal exercise capacity expressed as heart rate
Time frame: at baseline, after 6 and 12 month
Change of maximal exercise capacity expressed as heart rate reserve in percent
Time frame: at baseline, after 6 and 12 month
Change of maximal exercise capacity expressed as workload in Watt
Time frame: at baseline, after 6 and 12 month
Change of maximal exercise capacity expressed as workload in Watt / kg bodyweight
Time frame: at baseline, after 6 and 12 month
Change of maximal exercise capacity expressed as perceived exertion (Borg CR10 Scale) in number of level of exertion
Time frame: at baseline, after 6 and 12 month
Change of skill / performance related fitness expressed as push-ups in number of repetition in 40 sec.
Time frame: at baseline, after 6 and 12 month
Change of skill / performance related fitness expressed as standing broad jump in cm in children and adolescents
Time frame: at baseline, after 6 and 12 month
Change of skill / performance related fitness expressed as sit-up in number of repetition in 40 sec.
Time frame: at baseline, after 6 and 12 month
Change of skill / performance related fitness expressed as balancing backwards number in steps on a wooden beam 6 cm wide and 3 meters long
Time frame: at baseline, after 6 and 12 month
Change of skill / performance related fitness expressed as jump sideways in number of repetition in 15 sec.
Time frame: at baseline, after 6 and 12 month
Change of skill / performance related fitness expressed as flexibility in cm in children and adolescents
Time frame: at baseline, after 6 and 12 month
Change of skill / performance related fitness expressed as one leg stand in sec.
Time frame: at baseline, after 6 and 12 month
Change of skill / performance related fitness expressed as standing broad jump in cm in adults
Time frame: at baseline, after 6 and 12 month
Change of skill / performance related fitness expressed as trunk power in sec.
Time frame: at baseline, after 6 and 12 month
Change of skill / performance related fitness expressed as flexibility in cm in adults
Time frame: at baseline, after 6 and 12 month
Change of skill / performance related fitness expressed as circling motion in number of complete performed circles
Time frame: at baseline, after 6 and 12 month
Change of skill / performance related fitness expressed as the time of hip extension in sec.
Time frame: at baseline, after 6 and 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
- Derived from this study: PubMed 32661789Dietz-Terjung S, Gruber W, Sutharsan S, Taube C, Olivier M, Mellies U, Koerner-Rettberg C, Dillenhofer S, Stehling F, Welsner M. Association between habitual physical activity (HPA) and sleep quality in patients with cystic fibrosis. Sleep Breath. 2021 Jun;25(2):609-615. doi: 10.1007/s11325-020-02130-0. Epub 2020 Jul 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise program in people with Cystic Fibrosis, run by University Hospital, Essen at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of habitual physical activity in hours/day (time frame: at baseline, after 6 and 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03518697, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2019.