Feasibility Assessment of Adapted Physical Activity in Patients Treated for a Brain Tumor (APATC)
10 juni 2026 uppdaterad av: Center Eugene Marquis
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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
90
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Valérie JOLAINE
- Telefonnummer: 0299253036
- E-post: v.jolaine@rennes.unicancer.fr
Studieorter
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Rennes, Frankrike, 35000
- Centre Eugene Marquis
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Kontakt:
- Valérie JOLAINE
- Telefonnummer: 0299253036
- E-post: v.jolaine@rennes.unicancer.fr
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Huvudutredare:
- Elodie VAULEON, DR
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
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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.
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Experimentell: 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.
|
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.
|
|
Experimentell: 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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Effective adherence rate to the Adapted Physical Activity program
Tidsram: Baseline to 4 months
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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.
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Baseline to 4 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Adapted Physical Activity program observance rate
Tidsram: Baseline to 4 months
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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.
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Baseline to 4 months
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Retention rate during the 3-month supervised Adapted Physical Activity period
Tidsram: Baseline to 3 months
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Proportion of patients who complete the entire 3-month supervised APA program, reflecting their commitment and ability to sustain participation.
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Baseline to 3 months
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Retention Rate After Supervised Adapted Physical Activity Period
Tidsram: 4 months
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Proportion of patients who continue Adapted Physical Activity beyond the initial 3-month supervised period, assessed at 4 months.
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4 months
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Reasons for early discontinuation of Adapted Physical Activity
Tidsram: Baseline to 4 months
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Documentation of specific reasons (e.g., fatigue, disease progression, lack of motivation) for patients who discontinue Adapted Physical Activity prematurely
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Baseline to 4 months
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Quality of life assessment using EORTC Quality of Life Questionnaire - Brain Neoplasm Module 20
Tidsram: Baseline, 3 months, and 4 months
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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
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Baseline, 3 months, and 4 months
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Anxiety and depression assessment using Hospital Anxiety and Depression Scale questionnaire
Tidsram: Baseline, 3 months, and 4 months
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Evaluation of anxiety and depression levels using the Hospital Anxiety and Depression Scale, a validated tool for assessing psychological distress
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Baseline, 3 months, and 4 months
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Fatigue assessment using Multidimensional Fatigue Inventory-20 questionnaire
Tidsram: Baseline, 3 months, and 4 months
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Evaluation of multidimensional fatigue (general, physical, mental, reduced motivation, and reduced activity) using the Multidimensional Fatigue Inventory-20 questionnaire
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Baseline, 3 months, and 4 months
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Physical activity level assessment using International Physical Activity Questionnaire
Tidsram: Baseline, 3 months, and 4 months
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Evaluation of physical activity intensity and frequency using the International Physical Activity Questionnaire, which classifies participants into low, moderate, or high activity levels
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Baseline, 3 months, and 4 months
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Motivation for physical activity assessment using Behavioral Regulation in Exercise Questionnaire - Version 2
Tidsram: Baseline, 3 months, and 4 months
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Evaluation of motivation types (intrinsic, identified, introjected, external) using the Behavioral Regulation in Exercise Questionnaire - Version 2
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Baseline, 3 months, and 4 months
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Perceived enjoyment of physical activity assessment using Physical Activity Enjoyment Scale questionnaire
Tidsram: Baseline, 3 months, and 4 months
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Evaluation of enjoyment and satisfaction related to physical activity using the Physical Activity Enjoyment Scale questionnaire
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Baseline, 3 months, and 4 months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Elodie VAULEON, Dr, Centre de Lutte contre le Cancer Eugène Marquis
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juni 2026
Primärt slutförande (Beräknad)
1 juni 2028
Avslutad studie (Beräknad)
1 juni 2028
Studieregistreringsdatum
Först inskickad
30 april 2026
Först inskickad som uppfyllde QC-kriterierna
30 april 2026
Första postat (Faktisk)
6 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2025-4-79-002
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