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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Change of habitual physical activity in hours/day
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of CF
- •Informed consent
排除标准
- •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
研究组 & 干预措施
Exercise Group
- First 6 months supervised exercise program with telephone contact every two weeks
- Second 6 months exercise program without telephone contact
- Patients should increase habitual daily physical activity for 10-20 minutes per day 5 times per week
- Activities were chosen according to the preferences, interests, and severity of disease of the patients
- Activites should improve endurance, strength, coordination and flexibility
- 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)
干预措施: exercise program (Behavioral)
Control-Group
- 12 months usual routine care and habitual exercise in daily life.
- At start and after 12 month assessment of habitual exercise with accelerometry (Actigraph GTX3)
结局指标
主要结局
Change of habitual physical activity in hours/day
时间窗: at baseline, after 6 and 12 month
Measurement of the time of physical activity in hours/day by accelerometry (ActiGraph GT3X, Penascola, USA)
次要结局
- Change of habitual physical activity spend in light intensity (≤ 3METS) in minutes(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)(at baseline, after 6 and 12 month)
- Change of maximal exercise capacity expressed as heart rate reserve in percent(at baseline, after 6 and 12 month)
- Change of maximal exercise capacity expressed as workload in Watt(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(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(at baseline, after 6 and 12 month)
- Change of skill / performance related fitness expressed as jump sideways in number of repetition in 15 sec.(at baseline, after 6 and 12 month)
- Change of skill / performance related fitness expressed as standing broad jump in cm in adults(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)(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)(at baseline, after 6 and 12 month)
- Change of maximal exercise capacity expressed as workload in Watt / kg bodyweight(at baseline, after 6 and 12 month)
- Change of skill / performance related fitness expressed as sit-up in number of repetition in 40 sec.(at baseline, after 6 and 12 month)
- Change of skill / performance related fitness expressed as one leg stand in sec.(at baseline, after 6 and 12 month)
- Change of the duration of sleep in hours(at baseline, after 6 and 12 month)
- Determination of the exercise related barriers and barrier management in physical exercise(at baseline)
- Change of the quality of sleep in percent(at baseline, after 6 and 12 month)
- Change of skill / performance related fitness expressed as push-ups in number of repetition in 40 sec.(at baseline, after 6 and 12 month)
- Change of skill / performance related fitness expressed as standing broad jump in cm in children and adolescents(at baseline, after 6 and 12 month)
- Change of skill / performance related fitness expressed as flexibility in cm in children and adolescents(at baseline, after 6 and 12 month)
- Change of skill / performance related fitness expressed as trunk power in sec.(at baseline, after 6 and 12 month)
- Change of the quality of life in Cystic Fibrosis(at baseline, after 6 and 12 month)
- Change of habitual physical activity in steps/day(at baseline, after 6 and 12 month)
- Change of maximal exercise capacity expressed as heart rate(at baseline, after 6 and 12 month)
- Change of skill / performance related fitness expressed as flexibility in cm in adults(at baseline, after 6 and 12 month)
- Change of skill / performance related fitness expressed as the time of hip extension in sec.(at baseline, after 6 and 12 month)
- Change of skill / performance related fitness expressed as circling motion in number of complete performed circles(at baseline, after 6 and 12 month)
研究者
Florian Stehling
Dr. Florian Stehling, Head of Pediatric Pulmonology, Children´s Hospital
University Hospital, Essen