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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Brain Tumor Adult
• Intervention / Treatment: Other: adapted physical activity

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Valérie JOLAINE; Phone Number: 0299253036; Email: v.jolaine@rennes.unicancer.fr

Study Locations

• France
  • Rennes, France, 35000
    • Centre Eugene Marquis
    • Contact: Valérie JOLAINE; Phone Number: 0299253036; Email: v.jolaine@rennes.unicancer.fr
    • Principal Investigator: Elodie VAULEON, DR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effective adherence rate to the Adapted Physical Activity (APA) program	The primary outcome is the proportion of eligible patients who participate in at least one APA session out of the total number of eligible patients solicited for inclusion. This metric Evaluates the feasibility of APA implementation in brain tumor patients.	Baseline to 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
APA program observance rate	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.	Baseline to 4 months
Retention rate during the 3-month supervised APA period	Proportion of patients who complete the entire 3-month supervised APA program, reflecting their commitment and ability to sustain participation.	Baseline to 3 months
Retention Rate After Supervised APA Period	Proportion of patients who continue APA beyond the initial 3-month supervised period, assessed at 4 months.	4 months
Reasons for early discontinuation of APA	Documentation of specific reasons (e.g., fatigue, disease progression, lack of motivation) for patients who discontinue APA prematurely.	Baseline to 4 months
uality of life assessment using QLQ-BN20 questionnaire (EORTC Quality of Life Questionnaire - Brain Neoplasm Module 20)	Evaluation of brain tumor-specific quality of life using the EORTC QLQ-BN20 questionnaire, which assesses symptoms and functional domains relevant to brain tumor patients.	Baseline, 3 months, and 4 months
Anxiety and depression assessment using HADS (Hospital Anxiety and Depression Scale) questionnaire	Evaluation of anxiety and depression levels using the Hospital Anxiety and Depression Scale (HADS), a validated tool for assessing psychological distress.	Baseline, 3 months, and 4 months
Fatigue assessment using MFI-20 (Multidimensional Fatigue Inventory-20) questionnaire	Evaluation of multidimensional fatigue (general, physical, mental, reduced motivation, and reduced activity) using the Multidimensional Fatigue Inventory (MFI-20).	Baseline, 3 months, and 4 months
Physical activity level assessment using IPAQ (International Physical Activity Questionnaire) questionnaire	Evaluation of physical activity intensity and frequency using the International Physical Activity Questionnaire (IPAQ), which classifies participants into low, moderate, or high activity levels.	Baseline, 3 months, and 4 months
Motivation for physical activity assessment using BREQ-2 -Behavioral Regulation in Exercise Questionnaire - Version 2) questionnaire	Evaluation of motivation types (intrinsic, identified, introjected, external) using the Behavioral Regulation in Exercise Questionnaire (BREQ-2).	Baseline, 3 months, and 4 months
Perceived enjoyment of physical activity assessment using PACES (Physical Activity Enjoyment Scale) questionnaire	Evaluation of enjoyment and satisfaction related to physical activity using the PACES questionnaire.	Baseline, 3 months, and 4 months

Collaborators and Investigators

• Sponsor: Center Eugene Marquis
• Collaborators: University of Rennes 2
• Investigators: Principal Investigator: Elodie VAULEON, Dr, Centre de lutte contre le cancer Eugène Marquis

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: April 30, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Brain Tumor; Adapted physical activity (APA)
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: 2025-4-79-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No