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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCenter Eugene Marquis

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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),

Trial design

Design model

Parallel

Treatments tested in this trial

  • adapted physical activity

    Other intervention

    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.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: PA with Strength Sheets + Walking RecommendationExperimental treatment 1 intervention
Group B: APA with Strength Sheet + Group Videoconference SessionExperimental treatment 1 intervention
Group C: APA with Strength Sheet + Individual Home SessionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Effective adherence rate to the Adapted Physical Activity program

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.

Time frame
Baseline to 4 months

Secondary outcomes

1

Adapted Physical Activity 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.

Time frame
Baseline to 4 months
2

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

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

Time frame
Baseline to 3 months
3

Retention Rate After Supervised Adapted Physical Activity Period

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

Time frame
4 months
4

Reasons for early discontinuation of Adapted Physical Activity

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

Time frame
Baseline to 4 months

Other outcomes

Sponsors and contacts

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Center Eugene Marquis

Lead sponsor

University of Rennes 2

Collaborator

This trial is not recruiting at the moment. You can still explore other options: