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| Name | Class |
|---|---|
| University of Rennes 2 | OTHER |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PA with Strength Sheets + Walking Recommendation | Experimental | 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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| APA with Strength Sheet + Group Videoconference Session | Experimental | 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. |
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| APA with Strength Sheet + Individual Home Session | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adapted physical activity | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Effective adherence rate to the Adapted Physical Activity program | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adapted Physical Activity program observance rate | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Patients unable to comply with the study schedule for social, medical, or psychological reasons.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valérie JOLAINE | Contact | 0299253036 | v.jolaine@rennes.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| Elodie VAULEON, Dr | Centre de lutte contre le cancer Eugène Marquis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Eugène Marquis | Rennes | 35000 | France |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Evaluation of enjoyment and satisfaction related to physical activity using the Physical Activity Enjoyment Scale questionnaire | Baseline, 3 months, and 4 months |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |