Strength Training Exercises to Minimise Late Effects of Childhood Leukaemia or Lymphoma Among Adolescents - The STEEL Study - a National Multicenter Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 4
- 主要终点
- Isometric strength
研究概览
简要总结
We aim to include 60 children and adolescents aged 10 to 19 years who have undergone successful treatment for leukemia or lymphoma. Based on randomization, they will either 1) commence 16 weeks of training with STEEL or 2) commence 16 weeks of circuit training. STEEL training involves exercises for major muscle groups using free weights, body weight, or tailored machines. Circuit training is structured similarly to previous training for the target group and includes exercises using body weight, exercise balls, and rings. The training takes place in local centers either with friends or with other participants in the project. Before starting participation in the project, the child/adolescent and their parents or guardians will receive information about late effects, diet, sleep, and exercise, providing guidance and support regarding the project elements. The effects of the two training modalities will be evaluated based on self-reported quality of life, muscle strength, muscle mass, bone mineral content, fitness, and markers of metabolic syndrome (BMI, waist circumference, blood pressure, and blood analysis).
详细描述
The trial is designed as a national randomised clinical trial. Participants will be stratified by sex and block randomised (block sizes of 2 to 6) at 1:1 to either STEEL or the circuit training programme. A researcher not involved in the trial will generate the allocation sequence using a random number generator and is the only person who will know the block sizes. The study will be conducted at Aalborg University Hospital, Rigshospitalet, Odense University Hospital, and Aarhus University Hospital and was designed in collaboration with parents of childhood cancer survivors and an adult childhood cancer survivor suffering from late effects. Participants must attend three examinations at their respective hospitals: baseline and after 8 and 16 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ten to 19 years of age at the point of inclusion
- •A minimum of 12 months since the last chemotherapy with no upper limit
- •Ability to understand the physical intervention and general participant advice
排除标准
- •Participation in another research study that includes similar treatment
- •Pregnancy
- •Cardiac arrhythmia during exercise
- •Psychological disorders interfering with treatment
- •Presence of a clinical condition that needs immediate treatment
- •Planned surgeries within the subsequent 12 months that may interfere with performing exercises
- •Any contraindications to performing physical exercise as evaluated by the recruiting medical doctor
研究组 & 干预措施
STEEL
STEEL strength training will consist of progressive periodised training, in which the intensity is set to fit the individual's starting level and then gradually increases. During Week 1 to Week 5, the relative load will correspond to a 12-repetition maximum (RM). During Week 5 to Week 10, the relative load will be 10 RM, and during Week 11 to Week 16, the relative load will be 8 RM. The exercises will mostly consist of compound movements that activate the large muscle groups of the legs, back, arms and torso.
干预措施: STEEL (Other)
Circuit training
There will be 10 stations that include both strengthening and cardiovascular exercises, such as squats, hopping, crunches, stationary running, front-lying swimming, ski jumps, push-ups, ball throws, ring pulls, and hopscotch. Each station lasts 45 seconds, and there will be a 15-second break between each station. The circuit is repeated for three rounds. To ensure progression in intensity similar, we will progress the participants' rating of perceived exertion (RPE) over time. During Week 1 to Week 5, the RPE during exercises will be 6-7. During Week 5 to Week 10, the RPE will be 8-9, and during Week 11 to Week 16, the RPE will be 10.
干预措施: Circuit training (Other)
结局指标
主要结局
Isometric strength
时间窗: Baseline and at the 8-week and 16-week follow-ups
Measured in Nm based on tests of knee extension and flexion and elbow extension and flexion using handheld dynamometry
次要结局
- Step counts(Weekly throughout the 16-week intervention)
- Insulin(During baseline and at the 16-week follow-up)
- Proinsulin c-peptide(During baseline and at the 16-week follow-up)
- Total cholesterol(During baseline and at the 16-week follow-up)
- Homeostatic Model assessment for Insulin resistance score(During baseline and at the 16-week follow-up)
- Body Mass Index (BMI)(During baseline and at the 16-week follow-up)
- Self-reported Tanner staging(During baseline and at the 16-week follow-up)
- Blood pressure(During baseline and at the 16-week follow-up)
- Caloric expenditure(Weekly throughout the 16-week intervention)
- Bone mineral density of the lumbar spine and body composition(During baseline and at the 16-week follow-up)
- Muscular strength, endurance, and rate of force development(Baseline and at the 8-week and 16-week follow-ups)
- Glycated hemoglobin (Hba1c)(During baseline and at the 16-week follow-up)
- Low-density lipoprotein cholesterol(During baseline and at the 16-week follow-up)
- Health-related quality of life(During baseline and at the 16-week follow-up)
- Grip strength and rate of force development(Baseline and at the 8-week and 16-week follow-ups)
- Cardiorespiratory fitness and endurance(Baseline and at the 8-week and 16-week follow-ups)
- Satisfaction with the intervention(During the 16-week follow-up)
- Maximal dynamic strength(During the first and last training sessions of the 16-week intervention)
- Blood glucose(During baseline and at the 16-week follow-up)
- High-density lipoprotein cholesterol(During baseline and at the 16-week follow-up)
- Glucagon(During baseline and at the 16-week follow-up)
- Lean body mass(During baseline and at the 16-week follow-up)
- Abdominal circumference(During baseline and at the 16-week follow-up)
- Exercise compliance and fidelity(Throughout the 16-week intervention)
- Adverse events(Throughout the 16-week intervention)
- Movement-evoked pain(During baseline and at the 16-week follow-up)
- Fat mass(During baseline and at the 16-week follow-up)
- Android/gynoid fat distribution(During baseline and at the 16-week follow-up)
- Triglycerides(During baseline and at the 16-week follow-up)
- Very low-density lipoprotein cholesterol(During baseline and at the 16-week follow-up)
研究者
Henrik Riel
Postdoctoral researcher
Aalborg University