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

2026년 6월 10일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

90

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 프랑스
      • Rennes, 프랑스, 35000
        • Centre Eugène Marquis
        • 연락하다:
        • 수석 연구원:
          • Elodie VAULEON, DR

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
다른: 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.
실험적: 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.
다른: 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.
실험적: 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.
다른: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Effective adherence rate to the Adapted Physical Activity program
기간: 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.
Baseline to 4 months

2차 결과 측정

결과 측정
측정값 설명
기간
Adapted Physical Activity program observance rate
기간: 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 Adapted Physical Activity period
기간: 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 Adapted Physical Activity Period
기간: 4 months
Proportion of patients who continue Adapted Physical Activity beyond the initial 3-month supervised period, assessed at 4 months.
4 months
Reasons for early discontinuation of Adapted Physical Activity
기간: Baseline to 4 months
Documentation of specific reasons (e.g., fatigue, disease progression, lack of motivation) for patients who discontinue Adapted Physical Activity prematurely
Baseline to 4 months
Quality of life assessment using EORTC Quality of Life Questionnaire - Brain Neoplasm Module 20
기간: Baseline, 3 months, and 4 months
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
Baseline, 3 months, and 4 months
Anxiety and depression assessment using Hospital Anxiety and Depression Scale questionnaire
기간: Baseline, 3 months, and 4 months
Evaluation of anxiety and depression levels using the Hospital Anxiety and Depression Scale, a validated tool for assessing psychological distress
Baseline, 3 months, and 4 months
Fatigue assessment using Multidimensional Fatigue Inventory-20 questionnaire
기간: Baseline, 3 months, and 4 months
Evaluation of multidimensional fatigue (general, physical, mental, reduced motivation, and reduced activity) using the Multidimensional Fatigue Inventory-20 questionnaire
Baseline, 3 months, and 4 months
Physical activity level assessment using International Physical Activity Questionnaire
기간: Baseline, 3 months, and 4 months
Evaluation of physical activity intensity and frequency using the International Physical Activity Questionnaire, which classifies participants into low, moderate, or high activity levels
Baseline, 3 months, and 4 months
Motivation for physical activity assessment using Behavioral Regulation in Exercise Questionnaire - Version 2
기간: Baseline, 3 months, and 4 months
Evaluation of motivation types (intrinsic, identified, introjected, external) using the Behavioral Regulation in Exercise Questionnaire - Version 2
Baseline, 3 months, and 4 months
Perceived enjoyment of physical activity assessment using Physical Activity Enjoyment Scale questionnaire
기간: Baseline, 3 months, and 4 months
Evaluation of enjoyment and satisfaction related to physical activity using the Physical Activity Enjoyment Scale questionnaire
Baseline, 3 months, and 4 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Center Eugene Marquis

협력자

University of Rennes 2

수사관

  • 수석 연구원: Elodie VAULEON, Dr, Centre de lutte contre le cancer Eugène Marquis

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 1일

기본 완료 (추정된)

2028년 6월 1일

연구 완료 (추정된)

2028년 6월 1일

연구 등록 날짜

최초 제출

2026년 4월 30일

QC 기준을 충족하는 최초 제출

2026년 4월 30일

처음 게시됨 (실제)

2026년 5월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 10일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2025-4-79-002

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

뇌종양 성인에 대한 임상 시험

adapted physical activity에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Poland

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다