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

NCT ID: NCT07042932

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2030-12-31

Brief Summary

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.

Conditions

Acute Lymphoblastic Leukemia ALL; Childhood Cancer Survivors; Exercise; Rehabilitation Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Usual care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Exercise

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

Group Type: OTHER

Exercise

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Hanne Baekgaard Larsen

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin K Fridh, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Central Contacts

Martin K Fridh, Ph.D.

Role: CONTACT

martin.kaj.fridh@regionh.dk

+4528705827

Hanne B Larsen, Ph.D.

Role: CONTACT

hanne.baekgaard.larsen@regionh.dk

34459647

Other Identifiers

P-2024-15388

Identifier Type: -

Identifier Source: org_study_id