Acute Lymphoblastic Leukemia ALLOPAC-ALLNCT07042932
Online Physical Activity and Health Counseling for Survivors of Childhood Acute Lymphoblastic Leukemia
A study testing Exercise in people with Acute Lymphoblastic Leukemia ALL and Childhood Cancer Survivors, run by Copenhagen University Hospital, Rigshospitalet.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 21 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia ALL, Childhood Cancer Survivors, Exercise
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Children with a mental disability,
- other severe physical co-morbidity contradicting physical exercise,
- and/or terminal illness
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Online Physical Activity and Health Counseling for Survivors of Childhood Acute Lymphoblastic Leukemia (OPAC-ALL)
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
- Being tested
- Exercise
- Keywords
- Exercise, rehabilitation, Acute lymphoblastic leukemia, childhood cancer survivors
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at enrollment and 26 weeks after inclusion
Secondary outcomes (16)
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.
Measured: at enrollment, 26 weeks after inclusion, 52 weeks after inclusion, 1 year- post intervention assessment
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.
Measured: at 52 weeks after inclusion and 1-year post intervention
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.
Measured: at enrolment, 26-weeks after inclusion, 52 weeks after inclusion, 1-year post intervention
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.
Measured: at enrolment, 26 weeks after inclusion, 52 weeks after inclusion 1 year post intervention
Maximal Leg extension power:
Maximal voluntary muscle force will be measured from both legs following a fixed protocol. Leg extensor power will be measured using an extension Power Rig (Nottingham Power Rig, Queen's Medical Centre Nottingham, NG7 2UH, United Kingdom), with subjects positioned with joint angles as if the participant was rising from a chair. Participants are carefully instructed to keep their hands across the chest and to not move the upper body while pushing. Verbal encouragement will be given to ensure maximal performance. The participants extend one leg as forcefully as possible, and the velocity of the flywheel is measured by an opto-switch and used to calculate average leg extensor power in the push. Dominant leg will be tested, a minimum of 5 attempts is carried out for each leg, however the participant continues until two attempts are lower than the maximum (50). The result is expressed in watt (W).
Measured: at enrollment, 26 weeks after inclusion, 52 weeks after inclusion, 1 year post intervention
Body arthrometric:
Height (m) will be assessed without shoes to the nearest 0.1 cm. Weight (kg) will be measured (no shoes, with underwear or light clothing) to the nearest 0.1 kg and subsequently body mass index (BMI) will be calculated (kg/m2).
Measured: at enrollment, 26 weeks after inclusion, 52 weeks after inclusion, 1 year post intervention
Waist circumference
Waist circumference will be measured around the abdomen at the level of the umbilicus (cm)
Measured: at enrollment, 26 weeks after inclusion, 52 weeks after inclusion, 1 year post intervention
Quality of Life questionnaire
The Pediatric Quality of Life Inventory (PedsQL Core) [44] measures the quality of life in children using 23 items on a five-point response scale from never to almost always. The answers are divided into four domains: health and physical activity, emotions, dealing with others, and school activity.
Measured: at enrollment, 26 weeks after inclusion, 52 weeks after inclusion, 1 year post intervention
Fatigue/quality of life - PedsQL Multidimensional Fatigue Scale
Composed of 18 items, the PedsQL Multidimensional Fatigue Scale [44] possesses three subscales: general fatigue, sleep and rest fatigue, and cognitive fatigue.
Measured: at enrollment, 26 weeks after inclusion, 52 weeks after inclusion, 1 year post intervention
Prevalence of Metabolic syndrome:
Metabolic syndrome is based on waist and hip circumference, BMI, triglycerides, total cholesterol, high-density lipoprotein (HDL) cholesterol and low-density lipoprotein (LDL) cholesterol, blood pressure, fasting blood sugar and insulin; Within these parameters the International Diabetes Foundation (IDF)
Blood samples will be obtained following an overnight fast, measuring serum insulin, glucose, total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, total cholesterol, and triglyceride levels. We will collect 15-20 ml per blood sample, (maximum of 2 ml/kg/day including the volume taken for routine clinical analysis). Blood samples will be drawn from an antecubital vein.
In accordance with the WHO recommendations, no more than 2 ml/kg/day will be drawn and a maximum of 20mL (5). Local anesthetics cream will be used to minimize pain.
in mmol/L
Measured: at enrollment, 26 weeks after inclusion, 52 weeks after inclusion, 1 year post intervention
hip circumference
Hip circumference (in CM) at a level parallel to the floor, at the largest circumference of the buttocks following standards described by the World Health Organization. Metabolic syn-drome is based on age-based criterias defined by the International Diabetes Foundation
Measured: at enrollment, 26 weeks after inclusion, 52 weeks after inclusion, 1 year post intervention
Body Mass Index
Weight and Height is combined to report BMI in kg/m^2
Measured: at enrollment, 26 weeks after inclusion, 52 weeks after inclusion, 1 year post intervention
Body composition: Fat-Free Mass
Fat-Free Mass (kg and %) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body
Measured: at enrollment, 26 weeks after inclusion, 52 weeks after inclusion, 1 year post intervention
Body composition- Bone Mineral Density
Bone Mineral Density (g/cm2) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body
Measured: at enrollment, 26 weeks after inclusion, 52 weeks after inclusion, 1 year post intervention
Body composition: Bone Mineral Content
Bone Mineral Content (kg) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Measured: at enrollment, 26 weeks after inclusion, 52 weeks after inclusion, 1 year post intervention
Body composition: Body Fat
Body Fat (kg and %) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Cor-poration Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body
Measured: at enrollment, 26 weeks after inclusion, 52 weeks after inclusion, 1 year post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukemia ALLStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanne Baekgaard Larsen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Martin K Fridh, Ph.D, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042932
- Sponsor's protocol ID
- P-2024-15388
- Acronym
- OPAC-ALL
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: following the final analyses of the study, the IPD will be available upon request
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Physical Activity and Health Counseling for Survivors of Childhood Acute Lymphoblastic Leukemia (OPAC-ALL)
- ClinicalTrials.gov ID
- NCT07042932
- Acronym / sponsor ID
- OPAC-ALL / P-2024-15388
- Conditions
- Acute Lymphoblastic Leukemia ALL, Childhood Cancer Survivors, Exercise, Rehabilitation Exercise
- Keywords
- Exercise, rehabilitation, Acute lymphoblastic leukemia, childhood cancer survivors
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Exercisethe 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 |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Children with a mental disability,
- other severe physical co-morbidity contradicting physical exercise,
- and/or terminal illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise26 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 | Other | Exercise |
Primary outcome
cardiorespiratory fitness (VO2peak (ml/min/kg)
Time frame: at enrollment and 26 weeks after inclusion
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.
16 secondary outcomes
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
Body composition: Fat-Free Mass
Time frame: at enrollment, 26 weeks after inclusion, 52 weeks after inclusion, 1 year post intervention
Body composition- Bone Mineral Density
Time frame: at enrollment, 26 weeks after inclusion, 52 weeks after inclusion, 1 year post intervention
Body composition: Bone Mineral Content
Time frame: at enrollment, 26 weeks after inclusion, 52 weeks after inclusion, 1 year post intervention
Body composition: Body Fat
Time frame: at enrollment, 26 weeks after inclusion, 52 weeks after inclusion, 1 year post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: Yes. following the final analyses of the study, the IPD will be available upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martin K Fridh, Ph.D principal investigator
Copenhagen University Hospital, Rigshospitalet
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Acute Lymphoblastic Leukemia ALL and Childhood Cancer Survivors, run by Copenhagen University Hospital, Rigshospitalet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin K Fridh, Ph.D. (+4528705827, martin.kaj.fridh@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiorespiratory fitness (VO2peak (ml/min/kg) (time frame: at enrollment and 26 weeks after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.