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

Official title

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

Overview

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.

Interventions

• Other 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

Primary outcome measures

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

Secondary outcome measures (12)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07042932 · P-2024-15388

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗