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

Overview

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.

Interventions

• Other 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.

Primary outcome measures

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

Secondary outcome measures (10)

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

France · 1 center

• Centre Eugène Marquis — Rennes

Identifiers

NCT: NCT07570485 · 2025-4-79-002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗