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

NCT07570485 | Not Yet Recruiting

• 1 other identifier: 2025-4-79-002
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Tumor Adult

Keywords

Brain Tumor; Adapted physical activity (APA)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• APA program observance rate

  Baseline to 4 months

• Retention rate during the 3-month supervised APA period

  Baseline to 3 months

• Retention Rate After Supervised APA Period

  4 months

• Reasons for early discontinuation of APA

  Baseline to 4 months

• uality of life assessment using QLQ-BN20 questionnaire (EORTC Quality of Life Questionnaire - Brain Neoplasm Module 20)

  Baseline, 3 months, and 4 months

Study Arms (3)

PA with Strength Sheets + Walking Recommendation

EXPERIMENTAL

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

APA with Strength Sheet + Group Videoconference Session

EXPERIMENTAL

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

APA with Strength Sheet + Individual Home Session

EXPERIMENTAL

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

Interventions

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.

APA with Strength Sheet + Group Videoconference Session; APA with Strength Sheet + Individual Home Session; PA with Strength Sheets + Walking Recommendation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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),

You may not qualify if:

• 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.

Sponsors & Collaborators

• Center Eugene Marquis: lead
• University of Rennes 2: collaborator

Study Sites (1)

Centre Eugène Marquis

Rennes, 35000, France

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Elodie VAULEON, Dr

  Centre de lutte contre le cancer Eugène Marquis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valérie JOLAINE

CONTACT

0299253036; v.jolaine@rennes.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

FR (1)