跳至主要内容
临床试验/NCT07042932
NCT07042932尚未招募不适用

Online Physical Activity and Health Counseling for Survivors of Childhood Acute Lymphoblastic Leukemia (OPAC-ALL)

Rigshospitalet, Denmark0 个研究点目标入组 82 人开始时间: 2025年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
82
主要终点
cardiorespiratory fitness (VO2peak (ml/min/kg)

研究概览

简要总结

Advances in the medical treatment of childhood acute lymphoblastic leukemia (ALL) have resulted in 5-year survival rates above 90%- however, the success is not without consequences. Childhood ALL survivors experience markedly impaired physical capacity - reducing their opportunity to engage in everyday activities including leisure activities, sports, and school - affecting their quality of life. Furthermore, Childhood ALL survivors have markedly increased risk of chronic medical conditions including cardiometabolic diseases - that can be prevented through an active lifestyle. Thus, it is imperative to develop novel interventions that can mitigate these treatment-related late-effects. In this RCT, including 82 childhood ALL survivors (10-21 years-old), we will investigate a 26-week online exercise intervention combined with access to a lifestyle physical activity webpage, and health consultations on cardiorespiratory fitness (primary outcome) markers of metabolic syndrome, and physical activity habits.

While other pilot studies have investigated the effects of exercise for childhood ALL survivors, this study is the first RCT internationally to investigate the effects of online exercise combined with education through an app and health counselling for childhood ALL survivor. Using this approach, we are geographically able to reach every survivor in our targeted population, thereby, minimizing logistic challenges like travel distances.

This study has the potential to radically change the way physical rehabilitation is approached in childhood ALL survivors - Potentially changing the workflow of health professionals from referring only survivors with specific deficits to local physiotherapy to referring all survivors to an exercise program tailored to their needs. By improving the children's general physical capacity, we can give the children the required tools to re-enter everyday life activities, including school physical education, leisure activities, and sports earlier after treatment has ended - ultimately minimizing the social complications of treatment. This study will also answer the government´s call to digitalize 30% of rehabilitation by the 2030.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
10 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •aged 10-21 years old,
  • •at least one year from ended treatment of acute lymphoplastic leukemia
  • •not adhering to WHO's recommendations for physical activity (i.e., 60 minutes of daily moderate-to-vigorous intensity physical activity including two weekly sessions of strength training for children and 150 minutes of moderate-to-vigorous intensity weekly for adults),
  • •followed at the pediatric oncology out-patient clinic at Copenhagen University Hospital, Rigshospitalet.

排除标准

  • •Children with a mental disability,
  • •other severe physical co-morbidity contradicting physical exercise,
  • •and/or terminal illness

研究组 & 干预措施

Usual care

No Intervention

This arm will receive institutional follow-up care during the first 26 weeks. afterward they will receive the intervention

Exercise

Other

the intervention group will receive 26 weeks of online supervised exercise (1-2 sessions per week) + access to an 8 modele educational material on a webpage + weekly motivational counseling sessions

干预措施: Exercise (Other)

结局指标

主要结局

cardiorespiratory fitness (VO2peak (ml/min/kg)

时间窗: at enrollment and 26 weeks after inclusion

The primary outcome is the difference in cardiorespiratory fitness (VO2peak (ml/min/kg)) between the intervention group and the waiting list control group after 26- weeks. VO2peak is defined as the highest mean over 30 s and expressed in mL/kg/min Furthermore, two objective criteria need to be fulfilled before the test is valid. The criteria are heart rate \>85% of estimated maximal heart rate and a respiratory exchange ratio (RER)\>1.1.

次要结局

  • Physical activity and sedentary time(at enrollment, 26 weeks after inclusion, 52 weeks after inclusion, 1 year- post intervention assessment)
  • cardiorespiratory fitness (VO2peak (ml/min/kg)(at 52 weeks after inclusion and 1-year post intervention)
  • Lower extremity isometric knee extension strength:(at enrolment, 26-weeks after inclusion, 52 weeks after inclusion, 1-year post intervention)
  • Handgrip strength:(at enrolment, 26 weeks after inclusion, 52 weeks after inclusion 1 year post intervention)
  • Maximal Leg extension power:(at enrollment, 26 weeks after inclusion, 52 weeks after inclusion, 1 year post intervention)
  • Body arthrometric:(at enrollment, 26 weeks after inclusion, 52 weeks after inclusion, 1 year post intervention)
  • Waist circumference(at enrollment, 26 weeks after inclusion, 52 weeks after inclusion, 1 year post intervention)
  • Quality of Life questionnaire(at enrollment, 26 weeks after inclusion, 52 weeks after inclusion, 1 year post intervention)
  • Fatigue/quality of life - PedsQL Multidimensional Fatigue Scale(at enrollment, 26 weeks after inclusion, 52 weeks after inclusion, 1 year post intervention)
  • Prevalence of Metabolic syndrome:(at enrollment, 26 weeks after inclusion, 52 weeks after inclusion, 1 year post intervention)
  • hip circumference(at enrollment, 26 weeks after inclusion, 52 weeks after inclusion, 1 year post intervention)
  • Body Mass Index(at enrollment, 26 weeks after inclusion, 52 weeks after inclusion, 1 year post intervention)
  • Body composition: Fat-Free Mass(at enrollment, 26 weeks after inclusion, 52 weeks after inclusion, 1 year post intervention)
  • Body composition- Bone Mineral Density(at enrollment, 26 weeks after inclusion, 52 weeks after inclusion, 1 year post intervention)
  • Body composition: Bone Mineral Content(at enrollment, 26 weeks after inclusion, 52 weeks after inclusion, 1 year post intervention)
  • Body composition: Body Fat(at enrollment, 26 weeks after inclusion, 52 weeks after inclusion, 1 year post intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hanne Baekgaard Larsen

Associate Professor

Rigshospitalet, Denmark

相似试验