Effects of a 1-year Partially Supervised Exercise Program in Childhood Cancer Survivors - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 2
- 主要终点
- Composite cardiovascular risk score [z-score]
研究概览
简要总结
Exercise can play a major role to mitigate or even prevent late effects in cancer survivors, such as cardiovascular disease, obesity, osteoporosis, fatigue, depression, reduced quality of life, mental health and physical performance.
The objective of this study is to assess the effect of an exercise program of 1 year on cardiovascular health, obesity and diabetes, osteoporosis, physical fitness, mental health and quality of life in childhood cancer survivors. The investigators will recruit childhood cancer survivors aged 16 years and above from three Swiss paediatric oncology clinics and randomize them into an intervention and a control group. The intervention group will be asked to increase physical activity for 1 year by at least 2.5 hours of intense physical activity weekly. Regular feedback will be given via a step counter, an online activity diary, and by the centre staff. The control group participants will keep their activity level constant. All participants will be seen after 3, 6 and 12 months to assess health and quality of life parameters over one year. After 1 year, the control group is offered to receive the same intervention to profit as well from an active lifestyle.
If the program shows to be effective, a complete package will become available to interested centres treating paediatric cancer patients in Switzerland to promote exercise in all survivors. The program will allow clinicians without previous experience in exercise counselling to improve the care of their patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Registered in the Swiss Childhood Cancer Registry.
- •Age at cancer diagnosis <16 years.
- •Diagnosed with a cancer classifiable within the International Classification of Childhood Cancer (ICCC-3) or diagnosed with a Langerhans Cell Histiocytosis.
- •Diagnosed and/or treated at the University Children's Hospital Basel, Cantonal Hospital of Aarau and/or Cantonal Hospital of Lucerne.
- •Survived ≥5 years since primary cancer diagnosis or any subsequent cancer event (relapse or further cancer diagnoses)
- •Age at the time of the study ≥16 years
- •Informed Consent as documented by signature
排除标准
- •Participation in another clinical trial <4 weeks prior to baseline assessment (eventually later re-enrolment)
- •Contradiction to one of the inclusion criteria mentioned above
- •Inability to exercise
- •Exercise potentially harmful
- •Women who are pregnant or breast feeding
- •Women who intend to become pregnant during the course of the study
- •Instable clinical condition (eventually later re-enrolment)
- •Under treatment for relapse or further cancer diagnoses
- •Cardiac arrhythmias under exercise (during baseline assessment or by history)
- •Diagnosis of diabetes <3 months ago (eventually re-enrolment after 3 months if diabetes is under good control)
- •Detection of a clinical condition that needs immediate treatment during baseline assessments (eventually re-enrolment after 3 months if in stable clinical condition)
- •Planned relevant surgeries for the next 12 months
- •Major musculoskeletal injuries, fractures <2 months ago (eventually later re-enrolment)
- •Recent change in medication that interfere with the parameters of the CVD risk score (primary outcome) <1 month ago (eventually later re-enrolment)
- •>4 hours of reported vigorous activities per week
- •Inability to follow the procedures and understand the intervention and assessments of the study e.g. due to cognitive impairment, language problems, psychological disorders etc.
结局指标
主要结局
Composite cardiovascular risk score [z-score]
时间窗: 12 months
summarized mean z-score of waist circumference, blood pressure, HOMA-IR, inverted high density lipoprotein cholesterol, triglycerides and cardiorespiratory fitness
次要结局
- Leg strength and endurance [repetitions/min](6 and 12 months)
- Cortical bone mineral density [g/cm3 and z-scores](12 months)
- Total cross sectional bone area [mm2 and z-scores](12 months)
- Insulin resistance from response to oral glucose tolerance test (oGTT)(12 months)
- Absolute [kg] and relative [%] body fat mass(3, 6, and 12 months)
- Bone mineral content [g/cm and z-scores](12 months)
- Muscle cross-sectional area [cm2 and z-scores](12 months)
- Hand grip strength in the left and right hand [kg](6 and 12 months)
- Inverted high-density lipoprotein cholesterol (HDL) [mmol/l](6 and 12 months)
- Total and trabecular bone mineral density [g/cm3 and z-scores](12 months)
- Fatigue(3, 6 and 12 months)
- Homeostasis Model Assessment Insulin Resistance (HOMA-IR)(6 and 12 months)
- HbA1C [mmol/mol](6 and 12 months)
- Low-density lipoprotein cholesterol (LDL) [mmol/l](6 and 12 months)
- Body Mass Index (BMI) [z-score](3, 6, and 12 months)
- Cortical cross sectional bone area [mm2 and z-scores](12 months)
- Peak oxygen uptake (VO2max) [ml/(kg*min) and % predicted](6 and 12 months)
- Peak performance [watt/kg and % predicted](6 and 12 months)
- Heart rate recovery [delta beats/min](6 and 12 months)
- Total physical activity [counts/min](6 and 12 months)
- Sedentary behaviour [minutes/day](6 and 12 months)
- Number of steps per day [steps/day](6 and 12 months)
- Number of missing days in the online diary [n/year](12 months)
- Waist circumference [cm](3, 6, and 12 months)
- Systolic and diastolic blood pressure [mmHg](3, 6, and 12 months)
- Total cholesterol [mmol/l](6 and 12 months)
- Triglycerides [mmol/l](6 and 12 months)
- Areal bone mineral density [g/cm2 and z-scores](12 months)
- Moderate to vigorous physical activities [minutes/day](6 and 12 months)
- High impact activities with ground forces >3.9 G [n/day](6 and 12 month)
- Health related quality of life [T-score with mean=50, standard deviation=10 and range=0-100](6 and 12 months)
- Proportion of aimed physical activity reached [%](12 months)
- Psychological distress [T-score with mean=50, standard deviation=10 and range=0-100](6 and 12 months)
- Fatigue on a visual analogue scale (VAS) [mm](3, 6 and 12 months)
- Number of adverse events and serious adverse events [n](3, 6 and 12 months)
- Number of weeks where physical activity aim was reached [n/year](12 months)