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.
Přehled studie
Postavení
Intervence / Léčba
- Behaviorální: HII-Training (HIIT) 6 Months
- Diagnostický test: Cardiopulmonary exercise testing
- Diagnostický test: Echocardiography
- Diagnostický test: Electrocardiography (EKG)
- Diagnostický test: blood draw
- Diagnostický test: Questionnaire
- Diagnostický test: MSOT
- Behaviorální: HIT-Training (HIIT) 3 Months
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Isabelle Schöffl, MD
- Telefonní číslo: 09131-85-33118
- E-mail: isabelle.schoeffl@uk-erlangen.de
Studijní záloha kontaktů
- Jméno: Axel Karow, MD
- Telefonní číslo: 09131-85-33118
- E-mail: axel.karow@uk-erlangen.de
Studijní místa
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Baveria
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Erlangen, Baveria, Německo, 91054
- University Hospital Erlangen, Department for childhood and adolescence medicine
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Kontakt:
- Axel Karow, MD
- Telefonní číslo: 09131-85-33118
- E-mail: axel.karow@uk-erlangen.de
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: 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 |
|
Aktivní komparátor: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
VO2
Časové okno: 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
|
|
VO2max
Časové okno: 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
|
|
RER
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
|
HRR
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
|
VE
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
|
Echocardiography
Časové okno: 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
Časové okno: 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
|
|
Gender
Časové okno: 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
|
|
Weight
Časové okno: 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
|
|
Blood pressure
Časové okno: 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
Časové okno: 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
|
|
Immune reconstitution (IR)
Časové okno: 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
|
|
Oxygenated haemoglobin (HbO₂, MSOT)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
|
|
MSOT topogram of perfusion of the m. gastrocnemius
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Novotvary
- Novotvary podle histologického typu
- Hematologická onemocnění
- Hemická a lymfatická onemocnění
- Leukémie
- Vyšetřovací techniky
- Manipulace se vzorkem
- Klinické laboratorní techniky
- Diagnostické techniky a postupy
- Diagnóza
- Vpichy
- Chirurgické postupy, operativní
- Diagnostické zobrazování
- Diagnostické techniky, respirační systém
- Diagnostické techniky, kardiovaskulární
- Fyzické vyšetření
- Testy funkce srdce
- Testy respiračních funkcí
- Ergometrie
- Elektrodiagnostika
- Techniky srdečního zobrazování
- Ultrasonografie
- Neurologické vyšetření
- Cvičební test
- Elektrokardiografie
- Sběr vzorků krve
- Echokardiografie
- Měření bolesti
Další identifikační čísla studie
- HEALL
- TPRÄ_25_3_E_KARO (Jiné číslo grantu/financování: Bavarian Cancer Research Center (BZKF))
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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
Časový rámec sdílení IPD
Beginning 9 months and ending 36 months following article publication
Kritéria přístupu pro sdílení IPD
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.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
Informace o lécích a zařízeních, studijní dokumenty
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