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.
Descripción general del estudio
Estado
Intervención / Tratamiento
- Conductual: HII-Training (HIIT) 6 Months
- Prueba de diagnóstico: Cardiopulmonary exercise testing
- Prueba de diagnóstico: Echocardiography
- Prueba de diagnóstico: Electrocardiography (EKG)
- Prueba de diagnóstico: blood draw
- Prueba de diagnóstico: Questionnaire
- Prueba de diagnóstico: MSOT
- Conductual: HIT-Training (HIIT) 3 Months
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Isabelle Schöffl, MD
- Número de teléfono: 09131-85-33118
- Correo electrónico: isabelle.schoeffl@uk-erlangen.de
Copia de seguridad de contactos de estudio
- Nombre: Axel Karow, MD
- Número de teléfono: 09131-85-33118
- Correo electrónico: axel.karow@uk-erlangen.de
Ubicaciones de estudio
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Baveria
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Erlangen, Baveria, Alemania, 91054
- University Hospital Erlangen, Department for childhood and adolescence medicine
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Contacto:
- Axel Karow, MD
- Número de teléfono: 09131-85-33118
- Correo electrónico: axel.karow@uk-erlangen.de
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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 |
|
Comparador activo: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
VO2
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Neoplasias
- Neoplasias por tipo histológico
- Enfermedades hematológicas
- Enfermedades hemic y linfáticas
- Leucemia
- Técnicas de investigación
- Manejo de muestras
- Técnicas de laboratorio clínico
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Puntas
- Procedimientos quirúrgicos, operativo
- Imágenes de diagnóstico
- Técnicas de diagnóstico, sistema respiratorio
- Técnicas de diagnóstico, cardiovascular
- Examen físico
- Pruebas de funciones cardíacas
- Pruebas de funciones respiratorias
- Ergometría
- Electrodiagnóstico
- Técnicas de imágenes cardíacas
- Ultrasonografía
- Examen Neurológico
- Prueba de ejercicio
- Electrocardiografía
- Recolección de muestras de sangre
- Ecocardiografía
- Medición del Dolor
Otros números de identificación del estudio
- HEALL
- TPRÄ_25_3_E_KARO (Otro número de subvención/financiamiento: Bavarian Cancer Research Center (BZKF))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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
Marco de tiempo para compartir IPD
Beginning 9 months and ending 36 months following article publication
Criterios de acceso compartido de 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.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .