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Not yet recruitingNCT07936786HEALLUpdated Nov 13, 2026

HIIT-based Exercise Intervention for Improvement of Immunomodulatory, Cardiopulmonary, and Psychosocial Parameters During Maintenance Therapy of Paediatric Acute Lymphoblastic Leukaemia (HEALL)

An interventional study of HII-Training (HIIT) 6 Months and Cardiopulmonary exercise testing in Leukemia, HIIT and Sport, sponsored by University of Erlangen-Nürnberg Medical School. Not yet recruiting at 1 site in Germany. Open to participants aged 6 Years to 10 Years. Per ClinicalTrials.gov, last updated 2026-11-13.

Sponsored by University of Erlangen-Nürnberg Medical School · Not applicable, Interventional, and Treatment

Updated Nov 13, 2026Newly registeredGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
6 Years to 10 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 139 studies in Leukemia with a site in Germany — 19 open to participants now, 27 under way, 7 of them phase 3. Leukemia · Germany.

Planned enrollment
76th of 122
108 · median 177
Started
2027
the only one that year
No phase
9 of 139
1 open now
Primary completion
2028-07
later than 13 of 26 live
Registered
139th of 139
by date

Among the 139 studies in Leukemia with a site in Germany, this one is the 76th largest by planned enrollment of the 122 interventional ones that give a count, is the only one that started in 2027, is one of 9 with no phase, reaches primary completion later than 13 of the 26 other live ones, and was the 139th registered.

Leukemia

2,382 studies on the registry are indexed under Leukemia; 254 are open to participants now.

Browse Leukemia studies →

Open to participants now

19 of the 139 studies in Leukemia with a site in Germany are open now. Recruiting first, the newest first:

13 more — sign in →

All 19 open studies →

A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →

Who these studies take

Of the 208 Leukemia studies recruiting now, 112 (54%) set no upper age limit and 74 (36%) stop at 75 or younger; 86 take children under 18; 24 take healthy volunteers.

This study: 6 Years to 10 Years · all sexes · no healthy volunteers.

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02

Study summary

In this study, the investigators aim to examine the effects of high-intensity interval training (HIIT) on cardiopulmonary fitness and immunological recovery in female ALL survivors who underwent cancer treatment during childhood and adolescence.

03

Conditions studied

  • Leukemia
  • HIIT
  • Sport

Browse trials for

Keywords

  • HIIT
  • Leukemia
  • ALL
04

Who can participate

Ages eligible
6 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosed acute lymphatic leukemia
  • Begin of maintenance therapy
  • From 6 to 10 years of age
  • Physical ability to participate in HIIT and cardiopulmonary exercise testing

Exclusion criteria

Exclusion Criteria:

  • Known pleural or pericardial effusion
  • Critical condition (requiring respiratory support, ventilation, oxygen, shock, symptomatic heart failure)
  • Marked thoracic deformities/malformations
  • Previous lung surgery
  • Injuries that do not allow physical stress diagnostics
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
108 participants (estimated)

Study arms

  • Active comparator
    Intervention Group

    Total of 6 months of HIIT

    Behavioral: HII-Training (HIIT) 6 Months · Diagnostic Test: Cardiopulmonary exercise testing · Diagnostic Test: Echocardiography · Diagnostic Test: Electrocardiography (EKG) · Diagnostic Test: blood draw · Diagnostic Test: Questionnaire · Diagnostic Test: MSOT

  • Active comparator
    Control Group

    3 months without intervention followed by 3 months of HIIT

    Diagnostic Test: Cardiopulmonary exercise testing · Diagnostic Test: Echocardiography · Diagnostic Test: Electrocardiography (EKG) · Diagnostic Test: blood draw · Diagnostic Test: Questionnaire · Diagnostic Test: MSOT · Behavioral: HIT-Training (HIIT) 3 Months

Interventions

  • BehavioralHII-Training (HIIT) 6 Months

    HIIT should be done at least 2-3 times per week. Each session's duration is 60 minutes including warm-up and cool-down. Study participation will be monitored.

  • Diagnostic testCardiopulmonary exercise testing

    Treadmill Exercising Test

  • Diagnostic testEchocardiography

    Echocardiography with strain rate imaging

  • Diagnostic testElectrocardiography (EKG)

    Routine Electrocardiography

  • Diagnostic testblood draw

    Comprehensive fluorescence activated cell sorting (FACS) systematically assessing immune reconstitution of T-, B-, and NK cells after termination of intensive chemotherapy (5ml)

  • Diagnostic testQuestionnaire

    QoL: Kid-KINDL

  • Diagnostic testMSOT

    Multispectral-optoacustic imaging of the calf muscle

  • BehavioralHIT-Training (HIIT) 3 Months

    HIIT should be done at least 2-3 times per week. Each session's duration is 60 minutes including warm-up and cool-down. Study participation will be monitored.

06

What researchers measure

Primary outcomes

  1. VO2

    Oxygen uptake (VO2)

    Time frame: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

  2. VO2max

    peak oxygen uptake (VO2max)

    Time frame: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

  3. RER

    Respiratory exchange ratio (RER)

    Time frame: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

  4. VT2

    Ventilatory anaerobic threshold (VT2)

    Time frame: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

  5. VCO2

    Carbon dioxide output (VCO2)

    Time frame: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

  6. HR

    Heart rate (HR)

    Time frame: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

  7. HRR

    Heart Rate Reserve (HRR)

    Time frame: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

  8. Breath rate at VAT

    Breath rate at VAT

    Time frame: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

  9. BRR

    Breath rate reserve (BRR)

    Time frame: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

  10. VE

    minute ventilation (VE)

    Time frame: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

  11. O2 Pulse

    O2 Pulse

    Time frame: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

  12. HRV

    Heart rate variability (HRV)

    Time frame: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

  13. Echocardiography

    Myocardial function by echocardiographic strain and strain-rate imaging

    Time frame: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

  14. Age

    Age in years

    Time frame: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

  15. Gender

    Gender

    Time frame: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

  16. Weight

    Weight

    Time frame: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

  17. Blood pressure

    Blood pressure measurement

    Time frame: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

  18. QoL

    Quality of Life: Kid-KINDL

    Time frame: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

  19. Immune reconstitution (IR)

    T-, B- and natural killer cell count and marker expression profiles in FACS Blood sample (5ml)

    Time frame: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

  20. Oxygenated haemoglobin (HbO₂, MSOT)

    Oxygenated haemoglobin (HbO₂)

    Time frame: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

  21. Deoxygenated haemoglobin (HHb, MSOT)

    Deoxygenated haemoglobin (HHb)

    Time frame: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

  22. Total haemoglobin (tHb, MSOT)

    Total haemoglobin (tHb)

    Time frame: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

  23. Tissue oxygen saturation (sO₂, MSOT)

    Tissue oxygen saturation (sO₂)

    Time frame: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

  24. Signal Intensity (SI, MSOT)

    MSOT signal intensity per region of interest

    Time frame: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

  25. MSOT topogram of perfusion of the m. gastrocnemius

    MSOT topogram of perfusion of the m. gastrocnemius

    Time frame: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes — The raw, individual and identifiable patient data are protected and are not available due to data privacy laws. Further data sets are planned to be shared

Supporting information: Study protocol, Statistical analysis plan

Time frame: Beginning 9 months and ending 36 months following article publication

Access criteria: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request as follows: Individual participant data will not be available Study Protocol and Statistical Analysis Plan will be available The data will be available beginning 9 months and ending 36 months following article publication. The data will be available to researchers who provide a methodologically sound proposal. The data will be available for individual participant data meta-analysis, only. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at https://www.uk-erlangen.de. Restrictions may apply due to patient privacy and the General Data Protection Regulation.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2027; primary completion for Jul 2028, 18 months later.

Of 103 non-industry interventional studies with no phase under Leukemia, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 128. This study's planned 18 months is below that.

Counting every sponsor, half of 110 studies reached it within 38 months; a quarter within 22 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 29, 2026
First posted
Nov 13, 2026
StartEst.
Jan 1, 2027
Primary completionEst.
Jul 1, 2028
CompletionEst.
Jan 1, 2029
Last update
Nov 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 13, 2026
Show all 1 update
  1. Nov 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07936786
Collaborators
Bavarian Cancer Research Center (BZKF)
Responsible party
Sponsor
First posted
Nov 13, 2026
Start date
Jan 1, 2027 (estimated)
Primary completion
Jul 1, 2028 (estimated)
Completion
Jan 1, 2029 (estimated)
Last update
Nov 13, 2026

Study contacts

Isabelle Schöffl, MD
Contact
isabelle.schoeffl@uk-erlangen.de
09131-85-33118
Axel Karow, MD
Contact
axel.karow@uk-erlangen.de
09131-85-33118

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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