Feasibility Assessment of Adapted Physical Activity in Patients Treated for a Brain Tumor (APATC)
10. juni 2026 oppdatert 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
90
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Valérie JOLAINE
- Telefonnummer: 0299253036
- E-post: v.jolaine@rennes.unicancer.fr
Studiesteder
-
-
-
Rennes, Frankrike, 35000
- Centre Eugene Marquis
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Ta kontakt med:
- Valérie JOLAINE
- Telefonnummer: 0299253036
- E-post: v.jolaine@rennes.unicancer.fr
-
Hovedetterforsker:
- Elodie VAULEON, DR
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
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.
|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Effective adherence rate to the Adapted Physical Activity program
Tidsramme: 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.
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Baseline to 4 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Adapted Physical Activity program observance rate
Tidsramme: 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.
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Baseline to 4 months
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Retention rate during the 3-month supervised Adapted Physical Activity period
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Elodie VAULEON, Dr, Centre de Lutte contre le Cancer Eugène Marquis
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juni 2026
Primær fullføring (Antatt)
1. juni 2028
Studiet fullført (Antatt)
1. juni 2028
Datoer for studieregistrering
Først innsendt
30. april 2026
Først innsendt som oppfylte QC-kriteriene
30. april 2026
Først lagt ut (Faktiske)
6. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2025-4-79-002
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