Feasibility Assessment of Adapted Physical Activity in Patients Treated for a Brain Tumor

Обзор

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.

Вмешательства

• Другое adapted physical activity
  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.

Первичные конечные точки

• Effective adherence rate to the Adapted Physical Activity program [Срок оценки: Baseline to 4 months]

Вторичные конечные точки (10)

• Adapted Physical Activity program observance rate [Срок оценки: Baseline to 4 months]
• Retention rate during the 3-month supervised Adapted Physical Activity period [Срок оценки: Baseline to 3 months]
• Retention Rate After Supervised Adapted Physical Activity Period [Срок оценки: 4 months]
• Reasons for early discontinuation of Adapted Physical Activity [Срок оценки: Baseline to 4 months]
• Quality of life assessment using EORTC Quality of Life Questionnaire - Brain Neoplasm Module 20 [Срок оценки: Baseline, 3 months, and 4 months]
• Anxiety and depression assessment using Hospital Anxiety and Depression Scale questionnaire [Срок оценки: Baseline, 3 months, and 4 months]
• Fatigue assessment using Multidimensional Fatigue Inventory-20 questionnaire [Срок оценки: Baseline, 3 months, and 4 months]
• Physical activity level assessment using International Physical Activity Questionnaire [Срок оценки: Baseline, 3 months, and 4 months]
• Motivation for physical activity assessment using Behavioral Regulation in Exercise Questionnaire - Version 2 [Срок оценки: Baseline, 3 months, and 4 months]
• Perceived enjoyment of physical activity assessment using Physical Activity Enjoyment Scale questionnaire [Срок оценки: Baseline, 3 months, and 4 months]

Критерии участия

Критерии включения

• 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),

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• Centre Eugène Marquis — Rennes

Идентификаторы

NCT: NCT07570485 · 2025-4-79-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗