Brain Tumor AdultAPATCNCT07570485
Feasibility Assessment of Adapted Physical Activity in Patients Treated for a Brain Tumor
A study testing adapted physical activity in people with Brain Tumor Adult, run by Center Eugene Marquis at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor Adult
- What is being tested?
- adapted physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jul 2026to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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),
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Eugène Marquis
Rennes, 35000
Valérie JOLAINE, 0299253036, v.jolaine@rennes.unicancer.fr
Elodie VAULEON, DR
About this study
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:
Read more
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.
- Conditions
- Brain Tumor Adult
- Being tested
- adapted physical activity
- Keywords
- Brain Tumor, Adapted physical activity (APA)
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adapted physical activityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: adapted physical activity |
| 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. Receives: Other: adapted physical activity |
| 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. Receives: Other: adapted physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 4 months
Secondary outcomes (10)
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.
Measured: Baseline to 4 months
Retention rate during the 3-month supervised Adapted Physical Activity period
Proportion of patients who complete the entire 3-month supervised APA program, reflecting their commitment and ability to sustain participation.
Measured: 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.
Measured: 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
Measured: Baseline to 4 months
Quality of life assessment using EORTC Quality of Life Questionnaire - Brain Neoplasm Module 20. Minimum value = 0, maximum value = 100. A higher score mean a worse outcome.
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
Measured: 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. Minimum value = 0, maximum value = 21. A higher score mean a worse outcome.
Measured: 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. Minimum value = 4, maximum value = 20. The higher the score, the greater the fatigue.
Measured: 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. The higher the score, the higher the calculated energy expenditure.
Measured: 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
Measured: 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. Scoring range : 18 to 126 where higher scores indicate greater perceived enjoyment.
Measured: Baseline, 3 months, and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start8 Jul 2026
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Tumor AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center Eugene Marquis
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rennes 2
- Responsible party
- Sponsor
- Investigators
- Elodie VAULEON, Dr, Principal investigator, Centre de lutte contre le cancer Eugène Marquis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570485
- Sponsor's protocol ID
- 2025-4-79-002
- Acronym
- APATC
- Status last verified
- Oct 2026
- First submitted
- 30 Apr 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Assessment of Adapted Physical Activity in Patients Treated for a Brain Tumor
- ClinicalTrials.gov ID
- NCT07570485
- Acronym / sponsor ID
- APATC / 2025-4-79-002
- Conditions
- Brain Tumor Adult
- Keywords
- Brain Tumor, Adapted physical activity (APA)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Center Eugene MarquisUniversity, hospital or other
- Collaborators
- University of Rennes 2
- Study start
- 8 Jul 2026 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PA with Strength Sheets + Walking Recommendation | Experimental | Other: adapted physical activityPatients 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. |
| APA with Strength Sheet + Group Videoconference Session | Experimental | Other: adapted physical activityPatients 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. |
| APA with Strength Sheet + Individual Home Session | Experimental | Other: adapted physical activityPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adapted physical activityAdapted 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. | Other | APA with Strength Sheet + Group Videoconference Session, APA with Strength Sheet + Individual Home Session, PA with Strength Sheets + Walking Recommendation |
Primary outcome
Effective adherence rate to the Adapted Physical Activity program
Time frame: 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.
10 secondary outcomes
Adapted Physical Activity program observance rate
Time frame: Baseline to 4 months
Retention rate during the 3-month supervised Adapted Physical Activity period
Time frame: Baseline to 3 months
Retention Rate After Supervised Adapted Physical Activity Period
Time frame: 4 months
Reasons for early discontinuation of Adapted Physical Activity
Time frame: Baseline to 4 months
Quality of life assessment using EORTC Quality of Life Questionnaire - Brain Neoplasm Module 20. Minimum value = 0, maximum value = 100. A higher score mean a worse outcome.
Time frame: Baseline, 3 months, and 4 months
Anxiety and depression assessment using Hospital Anxiety and Depression Scale questionnaire
Time frame: Baseline, 3 months, and 4 months
Fatigue assessment using Multidimensional Fatigue Inventory-20 questionnaire
Time frame: Baseline, 3 months, and 4 months
Physical activity level assessment using International Physical Activity Questionnaire
Time frame: Baseline, 3 months, and 4 months
Motivation for physical activity assessment using Behavioral Regulation in Exercise Questionnaire - Version 2
Time frame: Baseline, 3 months, and 4 months
Perceived enjoyment of physical activity assessment using Physical Activity Enjoyment Scale questionnaire
Time frame: Baseline, 3 months, and 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elodie VAULEON, Dr principal investigator
Centre de lutte contre le cancer Eugène Marquis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adapted physical activity in people with Brain Tumor Adult, run by Center Eugene Marquis at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valérie JOLAINE (0299253036, v.jolaine@rennes.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective adherence rate to the Adapted Physical Activity program (time frame: Baseline to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.