About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Children with a mental disability,

other severe physical co-morbidity contradicting physical exercise,

and/or terminal illness

Trial design

Design model

Crossover

Treatments tested in this trial

Exercise
Other intervention
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

Treatment groups

82 Participants

are divided into 2 treatment groups

Group A: Usual careNo intervention 0 interventions

Group B: ExerciseOther 1 intervention

Trial outcomes

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.

Time frame

at enrollment and 26 weeks after inclusion

Secondary outcomes

1

Physical activity and sedentary time

Physical activity and sedentary time are assessed by accelerometers worn for 7 days. The accelerometers (ActiGraph™ model GT3X+, ActiGraph LLC, Pensacola FL, USA) measures accelerations of ±6 G. The sample rate will be set to measure raw signals at 100 Hz, translated into metabolic energy equivalents of light, moderate and vigorous physical activity, and sedentary time. The validity of the Actigraph accelerometer is good, with correlations of 0.65 between accelerometer assessed metabolic energy equivalents and indirect calorimetry Further, we will investigate whether international guidelines for physical activity are met according to established cut-off levels.

Time frame

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

2

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.

Time frame

at 52 weeks after inclusion and 1-year post intervention

3

Lower extremity isometric knee extension strength:

Isometric leg extension is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany) and amplifier. Data is collected through an AD-card (100 HZ) with customized software (LabVIEW ®, National Instruments, Texas, USA). Each participant receives detailed instructions on how to perform each test and is given time to familiarize with each test to secure valid measures. The participant is instructed to kick (forward) with maximal force and is obligated to keep maximal intensity for at least five seconds. Three attempts with a two-minute break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. The highest score is noted.

Time frame

at enrolment, 26-weeks after inclusion, 52 weeks after inclusion, 1-year post intervention

4

Handgrip strength:

Handgrip strength is measured using a hand-held dynamometer. Participants are placed in a seated position with the elbow flexed at 90°, with three attempts performed for each hand. During testing, the participant will be encouraged to exhibit the best possible force, and the best measure in the strongest hand will be used as test score.

Time frame

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

Other outcomes

1

Qualitative evaluation of the interventions

Experienced project members will conduct semi-structured, in-depth interviews of children and parents (interviewed separately) to understand factors that can influence an individual's likelihood of engaging in physical activity and their perceived experience with participating in the project. Moreover, the feasibility of the intervention components (i.e., online physical activity program, health counseling, lifestyle physical activity website, and education of local trainers) will be explored qualitatively. Furthermore, the health counseling sessions will be recorded. Analysis: All data will be transcribed and analyzed according to principles of pragmatic thematic analysis (semi-structured in-depth interviews) or content analysis (recording of health counseling sessions).

Time frame

at 26 weeks after inclusion

2

General Physical Acivity: Self-Report

An validated questionnaire used in the UNGkan and HEIA project will be used to assess self-reported physical activity, physical function, sedentary time, screen time, diet habits, active transportation behavior, physical education participation, perceived barriers/facilitators to physical activity, health-related behaviors. The questionnaire contains 35 items

Time frame

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

Locations

This trial has no locations.

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Locations

Sponsors and contacts