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.
Aperçu de l'étude
Statut
Intervention / Traitement
- Comportemental: HII-Training (HIIT) 6 Months
- Test diagnostique: Cardiopulmonary exercise testing
- Test diagnostique: Echocardiography
- Test diagnostique: Electrocardiography (EKG)
- Test diagnostique: blood draw
- Test diagnostique: Questionnaire
- Test diagnostique: MSOT
- Comportemental: HIT-Training (HIIT) 3 Months
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Isabelle Schöffl, MD
- Numéro de téléphone: 09131-85-33118
- E-mail: isabelle.schoeffl@uk-erlangen.de
Sauvegarde des contacts de l'étude
- Nom: Axel Karow, MD
- Numéro de téléphone: 09131-85-33118
- E-mail: axel.karow@uk-erlangen.de
Lieux d'étude
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Baveria
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Erlangen, Baveria, Allemagne, 91054
- University Hospital Erlangen, Department for childhood and adolescence medicine
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Contact:
- Axel Karow, MD
- Numéro de téléphone: 09131-85-33118
- E-mail: axel.karow@uk-erlangen.de
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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 |
|
Comparateur actif: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
VO2
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Tumeurs
- Tumeurs par type histologique
- Maladies hématologiques
- Maladies hémiques et lymphatiques
- Leucémie
- Techniques d'investigation
- Manipulation des échantillons
- Techniques de laboratoire clinique
- Techniques et procédures de diagnostic
- Diagnostic
- Perforation
- Procédures chirurgicales, opératoires
- Imagerie diagnostique
- Techniques de diagnostic, système respiratoire
- Techniques de diagnostic, cardiovasculaire
- Examen physique
- Tests de la fonction cardiaque
- Tests de fonction respiratoire
- Ergométrie
- Électrodiagnostic
- Techniques d'imagerie cardiaque
- Échographie
- Examen neurologique
- Test d'exercice
- Électrocardiographie
- Collection d'échantillons de sang
- Échocardiographie
- Mesure de la Douleur
Autres numéros d'identification d'étude
- HEALL
- TPRÄ_25_3_E_KARO (Autre subvention/numéro de financement: Bavarian Cancer Research Center (BZKF))
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime 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
Délai de partage IPD
Beginning 9 months and ending 36 months following article publication
Critères d'accès au partage 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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
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