NCT07042932: OPAC-ALL

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

Not yet recruiting NA Last updated 29 June 2025

What this trial tests

NA trial testing Exercise in Acute Lymphoblastic Leukemia ALL in 82 participants. Not yet recruiting.

Timeline

1 July 2025

Primary endpoint
31 December 2029

31 December 2030

Quick facts

Lead sponsor	Rigshospitalet, Denmark
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	prevention
Enrollment	82
Start date	1 July 2025
Primary completion	31 December 2029
Estimated completion	31 December 2030

Drugs / interventions tested

• Exercise

Conditions studied

• Acute Lymphoblastic Leukemia ALL — all drugs for Acute Lymphoblastic Leukemia ALL →
• Childhood Cancer Survivors — all drugs for Childhood Cancer Survivors →
• Exercise — all drugs for Exercise →
• Rehabilitation Exercise — all drugs for Rehabilitation Exercise →

Sponsor

Rigshospitalet, Denmark

Who can join

Adults 10 to 21, any sex, with Acute Lymphoblastic Leukemia ALL or Childhood Cancer Survivors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.