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

30. april 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

90

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Frankrig
      • Rennes, Frankrig, 35000
        • Centre Eugene Marquis
        • Kontakt:
        • Ledende efterforsker:
          • Elodie VAULEON, DR

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: adapted physical activity
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.
Eksperimentel: 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.
Andet: adapted physical activity
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.
Eksperimentel: 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.
Andet: adapted physical activity
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Effective adherence rate to the Adapted Physical Activity (APA) program
Tidsramme: Baseline to 4 months
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
APA 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.
Baseline to 4 months
Retention rate during the 3-month supervised APA period
Tidsramme: Baseline to 3 months
Proportion of patients who complete the entire 3-month supervised APA program, reflecting their commitment and ability to sustain participation.
Baseline to 3 months
Retention Rate After Supervised APA Period
Tidsramme: 4 months
Proportion of patients who continue APA beyond the initial 3-month supervised period, assessed at 4 months.
4 months
Reasons for early discontinuation of APA
Tidsramme: Baseline to 4 months
Documentation of specific reasons (e.g., fatigue, disease progression, lack of motivation) for patients who discontinue APA prematurely.
Baseline to 4 months
uality of life assessment using QLQ-BN20 questionnaire (EORTC Quality of Life Questionnaire - Brain Neoplasm Module 20)
Tidsramme: Baseline, 3 months, and 4 months
Evaluation of brain tumor-specific quality of life using the EORTC QLQ-BN20 questionnaire, which assesses symptoms and functional domains relevant to brain tumor patients.
Baseline, 3 months, and 4 months
Anxiety and depression assessment using HADS (Hospital Anxiety and Depression Scale) questionnaire
Tidsramme: Baseline, 3 months, and 4 months
Evaluation of anxiety and depression levels using the Hospital Anxiety and Depression Scale (HADS), a validated tool for assessing psychological distress.
Baseline, 3 months, and 4 months
Fatigue assessment using MFI-20 (Multidimensional Fatigue Inventory-20) questionnaire
Tidsramme: Baseline, 3 months, and 4 months
Evaluation of multidimensional fatigue (general, physical, mental, reduced motivation, and reduced activity) using the Multidimensional Fatigue Inventory (MFI-20).
Baseline, 3 months, and 4 months
Physical activity level assessment using IPAQ (International Physical Activity Questionnaire) questionnaire
Tidsramme: Baseline, 3 months, and 4 months
Evaluation of physical activity intensity and frequency using the International Physical Activity Questionnaire (IPAQ), which classifies participants into low, moderate, or high activity levels.
Baseline, 3 months, and 4 months
Motivation for physical activity assessment using BREQ-2 -Behavioral Regulation in Exercise Questionnaire - Version 2) questionnaire
Tidsramme: Baseline, 3 months, and 4 months
Evaluation of motivation types (intrinsic, identified, introjected, external) using the Behavioral Regulation in Exercise Questionnaire (BREQ-2).
Baseline, 3 months, and 4 months
Perceived enjoyment of physical activity assessment using PACES (Physical Activity Enjoyment Scale) questionnaire
Tidsramme: Baseline, 3 months, and 4 months
Evaluation of enjoyment and satisfaction related to physical activity using the PACES questionnaire.
Baseline, 3 months, and 4 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Center Eugene Marquis

Samarbejdspartnere

University of Rennes 2

Efterforskere

  • Ledende efterforsker: Elodie VAULEON, Dr, Centre de lutte contre le cancer Eugène Marquis

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2028

Studieafslutning (Anslået)

1. juni 2028

Datoer for studieregistrering

Først indsendt

30. april 2026

Først indsendt, der opfyldte QC-kriterier

30. april 2026

Først opslået (Faktiske)

6. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2025-4-79-002

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