Feasibility Assessment of Adapted Physical Activity in Patients Treated for a Brain Tumor (APATC)
10 de junio de 2026 actualizado por: Center Eugene Marquis
The goal of this clinical trial is to assess the feasibility of an adapted physical activity (APA) program in adult patients (≥18 years) with primary brain tumors, regardless of tumor type, grade, treatment stage, or the presence of motor, sensory, attention, concentration, or memory deficits.
The main question it aims to answer is:
What is the effective adherence rate to an APA program among eligible patients with primary brain tumors?
Additional questions include:
- What is the observance rate (number of sessions completed, intensity achieved, and duration) during the 3-month supervised APA program?
- What is the retention rate (proportion of patients completing the program and continuing APA beyond the initial period)?
- What is the impact of APA on quality of life, anxiety-depression, and cancer-related symptoms (measured via QLQ-BN20, HADS, and MFI-20 questionnaires at baseline, 3, and 4 months)?
Participants will:
- Undergo a 3-month supervised APA program (with possible continuation beyond this period).
- Use connected watches to monitor physical activity (if they accept the general conditions of use).
- Complete self-questionnaires (IPAQ, BREQ-2, QPP, QLQ-BN20, HADS, MFI-20) at inclusion, 3 months, and 4 months.
- Be followed for a total of 4 months after inclusion.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
90
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Valérie JOLAINE
- Número de teléfono: 0299253036
- Correo electrónico: v.jolaine@rennes.unicancer.fr
Ubicaciones de estudio
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Rennes, Francia, 35000
- Centre Eugene Marquis
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Contacto:
- Valérie JOLAINE
- Número de teléfono: 0299253036
- Correo electrónico: v.jolaine@rennes.unicancer.fr
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Investigador principal:
- Elodie VAULEON, DR
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Men or women ≥ 18 years old,
- Receiving medical oncology treatment at the CLCC Eugène Marquis,
- Diagnosed with a primary brain tumour, regardless of diagnosis, grade or treatment,
- Possible motor, sensory, attention, concentration, or memory deficits,
- Patients who accept the general terms of use for connected watches
- Patients affiliated with or covered by the French social security system,
- Patients who have received information and signed informed consent (or their legal representative),
Exclusion Criteria:
- WHO score ≥ 3
- Comprehension disorders that prevent participation in adapted physical activity
- Pregnant or breastfeeding women
- Patients without the necessary devices to use a smartwatch (smartphone, tablet or computer),
- Patients deprived of liberty, under guardianship, or curatorship, or subject to any other administrative safeguard measure.
Patients unable to comply with the study schedule for social, medical, or psychological reasons.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: PA with Strength Sheets + Walking Recommendation
Patients receive 2 strength exercise sheets to perform weekly at home + a recommendation to walk regularly (30 min/day).
No supervised sessions.
Activity is self-monitored via connected watch.
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Adapted Physical Activity (APA) is a tailored exercise program designed for individuals with specific health conditions, such as brain tumors.
It aims to improve physical function, quality of life, and overall well-being while ensuring safety and feasibility.
APA is supervised by trained professionals and adapted to each individual's abilities and needs.
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Experimental: APA with Strength Sheet + Group Videoconference Session
Patients receive 1 strength exercise sheet to perform weekly at home + 1 hour of group training via videoconference per week.
The videoconference session content matches the 2nd strength sheet from Arm 1. Activity is self-monitored via connected watch.
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Adapted Physical Activity (APA) is a tailored exercise program designed for individuals with specific health conditions, such as brain tumors.
It aims to improve physical function, quality of life, and overall well-being while ensuring safety and feasibility.
APA is supervised by trained professionals and adapted to each individual's abilities and needs.
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Experimental: APA with Strength Sheet + Individual Home Session
Patients receive 1 strength exercise sheet to perform weekly at home + 1 hour of individualized and personalized training at home per week.
The home session content matches the 2nd strength sheet from Arm 1. Activity is self-monitored via connected watch.
|
Adapted Physical Activity (APA) is a tailored exercise program designed for individuals with specific health conditions, such as brain tumors.
It aims to improve physical function, quality of life, and overall well-being while ensuring safety and feasibility.
APA is supervised by trained professionals and adapted to each individual's abilities and needs.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Effective adherence rate to the Adapted Physical Activity program
Periodo de tiempo: Baseline to 4 months
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The primary outcome is the proportion of eligible patients who participate in at least one Adapted Physical Activity session out of the total number of eligible patients solicited for inclusion.
This metric Evaluates the feasibility of Adapted Physical Activity implementation in brain tumor patients.
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Baseline to 4 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Adapted Physical Activity program observance rate
Periodo de tiempo: Baseline to 4 months
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Evaluated through the number of sessions completed, the number of sessions reaching the recommended intensity level, and the duration of sessions performed during the 3-month supervised period and the 1-month autonomous period.
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Baseline to 4 months
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Retention rate during the 3-month supervised Adapted Physical Activity period
Periodo de tiempo: Baseline to 3 months
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Proportion of patients who complete the entire 3-month supervised APA program, reflecting their commitment and ability to sustain participation.
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Baseline to 3 months
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Retention Rate After Supervised Adapted Physical Activity Period
Periodo de tiempo: 4 months
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Proportion of patients who continue Adapted Physical Activity beyond the initial 3-month supervised period, assessed at 4 months.
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4 months
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Reasons for early discontinuation of Adapted Physical Activity
Periodo de tiempo: Baseline to 4 months
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Documentation of specific reasons (e.g., fatigue, disease progression, lack of motivation) for patients who discontinue Adapted Physical Activity prematurely
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Baseline to 4 months
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Quality of life assessment using EORTC Quality of Life Questionnaire - Brain Neoplasm Module 20
Periodo de tiempo: Baseline, 3 months, and 4 months
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Evaluation of brain tumor-specific quality of life using the EORTC Quality of Life Questionnaire - Brain Neoplasm Module 20 questionnaire, which assesses symptoms and functional domains relevant to brain tumor patients
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Baseline, 3 months, and 4 months
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Anxiety and depression assessment using Hospital Anxiety and Depression Scale questionnaire
Periodo de tiempo: Baseline, 3 months, and 4 months
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Evaluation of anxiety and depression levels using the Hospital Anxiety and Depression Scale, a validated tool for assessing psychological distress
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Baseline, 3 months, and 4 months
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Fatigue assessment using Multidimensional Fatigue Inventory-20 questionnaire
Periodo de tiempo: Baseline, 3 months, and 4 months
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Evaluation of multidimensional fatigue (general, physical, mental, reduced motivation, and reduced activity) using the Multidimensional Fatigue Inventory-20 questionnaire
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Baseline, 3 months, and 4 months
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Physical activity level assessment using International Physical Activity Questionnaire
Periodo de tiempo: Baseline, 3 months, and 4 months
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Evaluation of physical activity intensity and frequency using the International Physical Activity Questionnaire, which classifies participants into low, moderate, or high activity levels
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Baseline, 3 months, and 4 months
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Motivation for physical activity assessment using Behavioral Regulation in Exercise Questionnaire - Version 2
Periodo de tiempo: Baseline, 3 months, and 4 months
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Evaluation of motivation types (intrinsic, identified, introjected, external) using the Behavioral Regulation in Exercise Questionnaire - Version 2
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Baseline, 3 months, and 4 months
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Perceived enjoyment of physical activity assessment using Physical Activity Enjoyment Scale questionnaire
Periodo de tiempo: Baseline, 3 months, and 4 months
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Evaluation of enjoyment and satisfaction related to physical activity using the Physical Activity Enjoyment Scale questionnaire
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Baseline, 3 months, and 4 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Elodie VAULEON, Dr, Centre de Lutte contre le Cancer Eugène Marquis
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de junio de 2026
Finalización primaria (Estimado)
1 de junio de 2028
Finalización del estudio (Estimado)
1 de junio de 2028
Fechas de registro del estudio
Enviado por primera vez
30 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
30 de abril de 2026
Publicado por primera vez (Actual)
6 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025-4-79-002
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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