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

NCT07042932 | Not Yet Recruiting DMC

• 1 other identifier: P-2024-15388
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

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

Keywords

Exercise; rehabilitation; Acute lymphoblastic leukemia; childhood cancer survivors

Outcome Measures

Primary Outcomes (1)

• cardiorespiratory fitness (VO2peak (ml/min/kg)

  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.

  at enrollment and 26 weeks after inclusion

Secondary Outcomes (16)

• 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

Other Outcomes (2)

• Qualitative evaluation of the interventions

  at 26 weeks after inclusion

• General Physical Acivity: Self-Report

  at enrollment, 26 weeks after inclusion, 52 weeks after inclusion, 1 year post intervention

Study Arms (2)

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

Other: Exercise

Interventions

Exercise 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

Exercise

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Martin K Fridh, Ph.D

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin K Fridh, Ph.D.

CONTACT

+4528705827; martin.kaj.fridh@regionh.dk

Hanne B Larsen, Ph.D.

CONTACT

34459647; hanne.baekgaard.larsen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The study is a randomized controlled trial with primary outcome of 26 weeks of exercise. Following primary outcome assessment, the control will receive the intervention components.

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 29, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP