Clinical trial NCT03518697: Effects of an Individualized Exercise Program on Health-related and Skill/Performance-related ﬁtness in CF.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Exercise
Physical fitness
Physical activity
Accelerometer
Sleep
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2018-05-08
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of CF
* Informed consent

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change of habitual physical activity in hours/day
timeFrame: at baseline, after 6 and 12 month
Secondary outcomes:
measure: Change of the quality of life in Cystic Fibrosis
timeFrame: at baseline, after 6 and 12 month
measure: Change of the duration of sleep in hours
timeFrame: at baseline, after 6 and 12 month
measure: Change of the quality of sleep in percent
timeFrame: at baseline, after 6 and 12 month
measure: Determination of the exercise related barriers and barrier management in physical exercise
timeFrame: at baseline
measure: Change of habitual physical activity in steps/day
timeFrame: at baseline, after 6 and 12 month
measure: Change of habitual physical activity spend in light intensity (≤ 3METS) in minutes
timeFrame: at baseline, after 6 and 12 month
measure: Change of habitual physical activity spend in moderate to vigorous intensity (3 to 5.9 METS) in minutes by accelerometry (ActiGraph GT3X, Penascola, USA)
timeFrame: at baseline, after 6 and 12 month
measure: Change of habitual physical activity spend in vigorous intensity (6 to 8.99 METS) in minutes by accelerometry (ActiGraph GT3X, Penascola, USA)
timeFrame: at baseline, after 6 and 12 month
measure: Change of habitual physical activity spend in hard intensity (≥ 9 METS) in minutes by accelerometry (ActiGraph GT3X, Penascola, USA)
timeFrame: at baseline, after 6 and 12 month
measure: Change of maximal exercise capacity expressed as heart rate
timeFrame: at baseline, after 6 and 12 month
measure: Change of maximal exercise capacity expressed as heart rate reserve in percent
timeFrame: at baseline, after 6 and 12 month
measure: Change of maximal exercise capacity expressed as workload in Watt
timeFrame: at baseline, after 6 and 12 month
measure: Change of maximal exercise capacity expressed as workload in Watt / kg bodyweight
timeFrame: at baseline, after 6 and 12 month
measure: Change of maximal exercise capacity expressed as perceived exertion (Borg CR10 Scale) in number of level of exertion
timeFrame: at baseline, after 6 and 12 month
measure: Change of skill / performance related fitness expressed as push-ups in number of repetition in 40 sec.
timeFrame: at baseline, after 6 and 12 month
measure: Change of skill / performance related fitness expressed as standing broad jump in cm in children and adolescents
timeFrame: at baseline, after 6 and 12 month
measure: Change of skill / performance related fitness expressed as sit-up in number of repetition in 40 sec.
timeFrame: at baseline, after 6 and 12 month
measure: Change of skill / performance related fitness expressed as balancing backwards number in steps on a wooden beam 6 cm wide and 3 meters long
timeFrame: at baseline, after 6 and 12 month
measure: Change of skill / performance related fitness expressed as jump sideways in number of repetition in 15 sec.
timeFrame: at baseline, after 6 and 12 month
measure: Change of skill / performance related fitness expressed as flexibility in cm in children and adolescents
timeFrame: at baseline, after 6 and 12 month
measure: Change of skill / performance related fitness expressed as one leg stand in sec.
timeFrame: at baseline, after 6 and 12 month
measure: Change of skill / performance related fitness expressed as standing broad jump in cm in adults
timeFrame: at baseline, after 6 and 12 month
measure: Change of skill / performance related fitness expressed as trunk power in sec.
timeFrame: at baseline, after 6 and 12 month
measure: Change of skill / performance related fitness expressed as flexibility in cm in adults
timeFrame: at baseline, after 6 and 12 month
measure: Change of skill / performance related fitness expressed as circling motion in number of complete performed circles
timeFrame: at baseline, after 6 and 12 month
measure: Change of skill / performance related fitness expressed as the time of hip extension in sec.
timeFrame: at baseline, after 6 and 12 month
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: St. Josef-Hospital im Katholischen Klinikum Bochum, Klinik für Kinder und Jugendmedizin, Alexandrinenstrasse 5
city: Essen
country: Germany
facility: Universitätsklinikum Essen, Klinik für Kinderheilkunde III, Pädiatrische Pneumologie und Schlafmedizin, Hufelandstr. 55
city: Essen
country: Germany
facility: Ruhrlandklinik Essen, Westdeutsches Lungenzentrum am Universitätsklinikum Essen, Tuschener Weg 40
Study officials:
References:
citation: 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.