Feasibility Assessment of Adapted Physical Activity in Patients Treated for a Brain Tumor (APATC)
10 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
90
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Valérie JOLAINE
- Numéro de téléphone: 0299253036
- E-mail: v.jolaine@rennes.unicancer.fr
Lieux d'étude
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Rennes, France, 35000
- Centre Eugene Marquis
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Contact:
- Valérie JOLAINE
- Numéro de téléphone: 0299253036
- E-mail: v.jolaine@rennes.unicancer.fr
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Chercheur principal:
- Elodie VAULEON, DR
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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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Expérimental: 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.
|
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.
|
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Effective adherence rate to the Adapted Physical Activity program
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Adapted Physical Activity program observance rate
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Elodie VAULEON, Dr, Centre de Lutte contre le Cancer Eugène Marquis
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 juin 2026
Achèvement primaire (Estimé)
1 juin 2028
Achèvement de l'étude (Estimé)
1 juin 2028
Dates d'inscription aux études
Première soumission
30 avril 2026
Première soumission répondant aux critères de contrôle qualité
30 avril 2026
Première publication (Réel)
6 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
12 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
10 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025-4-79-002
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .