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NCT Number: NCT07570485

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

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.

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Key information

Conditions

Brain Tumor Adult Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Eugène Marquis

Rennes, 35000, France

Location contact

Elodie VAULEON, DR

PRINCIPAL_INVESTIGATOR

Valérie JOLAINE

CONTACT

[email protected]

0299253036

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

adapted physical activity

Other

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 outcomes

  1. Effective adherence rate to the Adapted Physical Activity program

    Time frame: Baseline to 4 months

    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.

Secondary outcomes

  1. Adapted Physical Activity program observance rate

    Time frame: Baseline to 4 months

    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.

  2. Retention rate during the 3-month supervised Adapted Physical Activity period

    Time frame: Baseline to 3 months

    Proportion of patients who complete the entire 3-month supervised APA program, reflecting their commitment and ability to sustain participation.

  3. Retention Rate After Supervised Adapted Physical Activity Period

    Time frame: 4 months

    Proportion of patients who continue Adapted Physical Activity beyond the initial 3-month supervised period, assessed at 4 months.

  4. Reasons for early discontinuation of Adapted Physical Activity

    Time frame: Baseline to 4 months

    Documentation of specific reasons (e.g., fatigue, disease progression, lack of motivation) for patients who discontinue Adapted Physical Activity prematurely

  5. Quality of life assessment using EORTC Quality of Life Questionnaire - Brain Neoplasm Module 20

    Time frame: Baseline, 3 months, and 4 months

    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

  6. Anxiety and depression assessment using Hospital Anxiety and Depression Scale questionnaire

    Time frame: Baseline, 3 months, and 4 months

    Evaluation of anxiety and depression levels using the Hospital Anxiety and Depression Scale, a validated tool for assessing psychological distress

  7. Fatigue assessment using Multidimensional Fatigue Inventory-20 questionnaire

    Time frame: Baseline, 3 months, and 4 months

    Evaluation of multidimensional fatigue (general, physical, mental, reduced motivation, and reduced activity) using the Multidimensional Fatigue Inventory-20 questionnaire

  8. Physical activity level assessment using International Physical Activity Questionnaire

    Time frame: Baseline, 3 months, and 4 months

    Evaluation of physical activity intensity and frequency using the International Physical Activity Questionnaire, which classifies participants into low, moderate, or high activity levels

  9. Motivation for physical activity assessment using Behavioral Regulation in Exercise Questionnaire - Version 2

    Time frame: Baseline, 3 months, and 4 months

    Evaluation of motivation types (intrinsic, identified, introjected, external) using the Behavioral Regulation in Exercise Questionnaire - Version 2

  10. Perceived enjoyment of physical activity assessment using Physical Activity Enjoyment Scale questionnaire

    Time frame: Baseline, 3 months, and 4 months

    Evaluation of enjoyment and satisfaction related to physical activity using the Physical Activity Enjoyment Scale questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Valérie JOLAINE

CONTACT

[email protected]

0299253036

Sponsors and collaborators

Lead sponsor

Center Eugene Marquis

Other

Collaborators

  • University of Rennes 2

Registry information

Acronym: APATC

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 6, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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