HIIT-based Exercise Intervention for Improvement of Immunomodulatory, Cardiopulmonary, and Psychosocial Parameters During Maintenance Therapy of Paediatric Acute Lymphoblastic Leukaemia (HEALL) (HEALL)
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.
Studie Overzicht
Toestand
Interventie / Behandeling
- Gedragsmatig: HII-Training (HIIT) 6 Months
- Diagnostische toets: Cardiopulmonary exercise testing
- Diagnostische toets: Echocardiography
- Diagnostische toets: Electrocardiography (EKG)
- Diagnostische toets: blood draw
- Diagnostische toets: Questionnaire
- Diagnostische toets: MSOT
- Gedragsmatig: HIT-Training (HIIT) 3 Months
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Isabelle Schöffl, MD
- Telefoonnummer: 09131-85-33118
- E-mail: isabelle.schoeffl@uk-erlangen.de
Studie Contact Back-up
- Naam: Axel Karow, MD
- Telefoonnummer: 09131-85-33118
- E-mail: axel.karow@uk-erlangen.de
Studie Locaties
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Baveria
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Erlangen, Baveria, Duitsland, 91054
- University Hospital Erlangen, Department for childhood and adolescence medicine
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Contact:
- Axel Karow, MD
- Telefoonnummer: 09131-85-33118
- E-mail: axel.karow@uk-erlangen.de
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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:
- 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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: Intervention Group
Total of 6 months of HIIT |
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. Treadmill Exercising Test Echocardiography with strain rate imaging Routine Electrocardiography Comprehensive fluorescence activated cell sorting (FACS) systematically assessing immune reconstitution of T-, B-, and NK cells after termination of intensive chemotherapy (5ml) QoL: Kid-KINDL Multispectral-optoacustic imaging of the calf muscle |
|
Actieve vergelijker: Control Group
3 months without intervention followed by 3 months of HIIT |
Treadmill Exercising Test Echocardiography with strain rate imaging Routine Electrocardiography Comprehensive fluorescence activated cell sorting (FACS) systematically assessing immune reconstitution of T-, B-, and NK cells after termination of intensive chemotherapy (5ml) QoL: Kid-KINDL Multispectral-optoacustic imaging of the calf muscle 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
VO2
Tijdsspanne: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
Oxygen uptake (VO2) |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
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VO2max
Tijdsspanne: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
peak oxygen uptake (VO2max) |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
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RER
Tijdsspanne: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
Respiratory exchange ratio (RER) |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
|
VT2
Tijdsspanne: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
Ventilatory anaerobic threshold (VT2) |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
|
VCO2
Tijdsspanne: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
Carbon dioxide output (VCO2) |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
|
HR
Tijdsspanne: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
Heart rate (HR) |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
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HRR
Tijdsspanne: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
Heart Rate Reserve (HRR) |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
|
Breath rate at VAT
Tijdsspanne: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
Breath rate at VAT |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
|
BRR
Tijdsspanne: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
Breath rate reserve (BRR) |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
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VE
Tijdsspanne: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
minute ventilation (VE) |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
|
O2 Pulse
Tijdsspanne: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
O2 Pulse |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
|
HRV
Tijdsspanne: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
Heart rate variability (HRV) |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
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Echocardiography
Tijdsspanne: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
Myocardial function by echocardiographic strain and strain-rate imaging |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
|
Age
Tijdsspanne: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
Age in years |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
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Gender
Tijdsspanne: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
Gender |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
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Weight
Tijdsspanne: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
Weight |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
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Blood pressure
Tijdsspanne: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
Blood pressure measurement |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
|
QoL
Tijdsspanne: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
Quality of Life: Kid-KINDL |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
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Immune reconstitution (IR)
Tijdsspanne: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
T-, B- and natural killer cell count and marker expression profiles in FACS Blood sample (5ml) |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
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Oxygenated haemoglobin (HbO₂, MSOT)
Tijdsspanne: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
Oxygenated haemoglobin (HbO₂) |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
|
Deoxygenated haemoglobin (HHb, MSOT)
Tijdsspanne: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
Deoxygenated haemoglobin (HHb) |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
|
Total haemoglobin (tHb, MSOT)
Tijdsspanne: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
Total haemoglobin (tHb) |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
|
Tissue oxygen saturation (sO₂, MSOT)
Tijdsspanne: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
Tissue oxygen saturation (sO₂) |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
|
Signal Intensity (SI, MSOT)
Tijdsspanne: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
MSOT signal intensity per region of interest |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
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MSOT topogram of perfusion of the m. gastrocnemius
Tijdsspanne: 3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
MSOT topogram of perfusion of the m. gastrocnemius |
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
|
Medewerkers en onderzoekers
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata
- Neoplasmata per histologisch type
- Hematologische ziekten
- Hemische en lymfatische ziekten
- Leukemie
- Onderzoekstechnieken
- Exemplaarbehandeling
- Klinische laboratoriumtechnieken
- Diagnostische technieken en procedures
- Diagnose
- Buren
- Chirurgische procedures, operatief
- Diagnostische beeldvorming
- Diagnostische technieken, ademhalingssysteem
- Diagnostische technieken, cardiovasculair
- Lichamelijk onderzoek
- Hartfunctietests
- Ademhalingsfunctietests
- Ergometrie
- Elektrodiagnose
- Cardiale beeldvormingstechnieken
- Ultrasonografie
- Neurologisch Onderzoek
- Trainingstest
- Elektrocardiografie
- Bloedspecimenverzameling
- Echocardiografie
- Pijnmeting
Andere studie-ID-nummers
- HEALL
- TPRÄ_25_3_E_KARO (Ander subsidie-/financieringsnummer: Bavarian Cancer Research Center (BZKF))
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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
IPD-tijdsbestek voor delen
Beginning 9 months and ending 36 months following article publication
IPD-toegangscriteria voor delen
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.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
Informatie over medicijnen en apparaten, studiedocumenten
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