Feasibility Assessment of Adapted Physical Activity in Patients Treated for a Brain Tumor
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Effective adherence rate to the Adapted Physical Activity (APA) program
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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),
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: adapted physical activity (Other)
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.
干预措施: adapted physical activity (Other)
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.
干预措施: adapted physical activity (Other)
结局指标
主要结局
Effective adherence rate to the Adapted Physical Activity (APA) program
时间窗: 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.
次要结局
- APA program observance rate(Baseline to 4 months)
- Retention rate during the 3-month supervised APA period(Baseline to 3 months)
- Retention Rate After Supervised APA Period(4 months)
- Reasons for early discontinuation of APA(Baseline to 4 months)
- uality of life assessment using QLQ-BN20 questionnaire (EORTC Quality of Life Questionnaire - Brain Neoplasm Module 20)(Baseline, 3 months, and 4 months)
- Anxiety and depression assessment using HADS (Hospital Anxiety and Depression Scale) questionnaire(Baseline, 3 months, and 4 months)
- Fatigue assessment using MFI-20 (Multidimensional Fatigue Inventory-20) questionnaire(Baseline, 3 months, and 4 months)
- Physical activity level assessment using IPAQ (International Physical Activity Questionnaire) questionnaire(Baseline, 3 months, and 4 months)
- Motivation for physical activity assessment using BREQ-2 -Behavioral Regulation in Exercise Questionnaire - Version 2) questionnaire(Baseline, 3 months, and 4 months)
- Perceived enjoyment of physical activity assessment using PACES (Physical Activity Enjoyment Scale) questionnaire(Baseline, 3 months, and 4 months)