Online Physical Activity and Health Counseling for Survivors of Childhood Acute Lymphoblastic Leukemia

Официальное название

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

Обзор

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.

Вмешательства

• Другое Exercise
  26 weeks online high intensity functional training, performed 1-2 times per week + access to a LIFESTYLE PHYSICAL ACTIVITY WEBSITE including 8 modules; 1) Welcome, information about the intervention and the aims of the study, 2) Living a physically active lifestyle, 3) Sedentary behavior, 4) General exercise recommendations, 5) How to stay motivated, 6) Strength training, 7) flexibility, balance, and coordination, and 8) Healthy eating + weekly motivational counseling

Первичные конечные точки

• cardiorespiratory fitness (VO2peak (ml/min/kg) [Срок оценки: at enrollment and 26 weeks after inclusion]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07042932 · P-2024-15388

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗