Brain TumorNCT05554159
A Virtually Delivered Exercise Intervention To Mitigate Cognitive Deficits From Radiotherapy In AYAs With Brain Tumors
A study testing Standard Fitbit Program and Virtual Exercise Program in people with Brain Tumor and Brain Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To test a new investigational virtual exercise program for adolescents and young adults (AYAs) with brain tumors who plan to receive cranial radiotherapy Read more about this study
- Who is it for?
- Ages 15 to 39 years
- Conditions the study is for
- Brain Tumor, Brain Cancer
- What is being tested?
- Standard Fitbit Program and Virtual Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2023to 28 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 15-39 years old
- Self-reported diagnosis of a primary benign or malignant brain tumor or confirmed diagnosis of primary benign or malignant brain tumor radiographically or pathologically when available (relapse or newly diagnosed)
- Plans to receive CRT at MDACC or, if the participant has already started CRT, the participant is eligible if they are within 3 weeks of the start of CRT
- Received appropriate physician clearance
- Able to move arms and legs, and ambulate safely
- Participant is insufficiently active (reports less than 150 minutes of planned moderate-vigorous intensity activity per week in the prior week)
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- Participants and/or guardians are willing and able to provide informed consent
- Has a smartphone with available space to download additional apps
- Does not have sensorimotor strip impairment as indicated by the clinical team
- Has internet access
- Can receive physical therapy because this is part of the standard of care
- Participants and/or guardians are willing and able to provide informed consent for protocol PA18-0130 (Pediatric Energy Balance Data Repository Study), companion protocol for the Fitbit application/assessment.
Who cannot join
- Non-English speaking
- Screen failure for exercise safety based on Physical Activity Readiness Questionnaire (PAR-Q).12
- Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease
- Recent fracture or acute musculoskeletal injury that precludes ability to participate in supervised exercise training sessions
- Cognitive and/or major sensory deficits that would impede the completion of research activities and assessments as deemed by the clinical team.
- Self-reported diagnosis of a metastatic brain tumor or confirmed diagnosis of a metastatic brain tumor radiographically or pathologically when available
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- Self-report of pregnancy
- Currently enrolled in another physical activity or exercise intervention
- Prisoners
- Self-reported pregnancy status
Trial locations and contacts
1 site in 1 country.
About this study
To test a new investigational virtual exercise program for adolescents and young adults (AYAs) with brain tumors who plan to receive cranial radiotherapy
Read the detailed description
Primary Objective:
Determine the feasibility and acceptability of a virtually supervised exercise intervention compared to control in AYAs with brain tumors undergoing cranial radiotherapy (CRT).
Secondary Objective:
Assess the effect of supervised exercise intervention on the neuroanatomic structure and cognitive function changes in AYAs with brain tumors undergoing CRT.
Exploratory Objective:
Assess the effect of supervised exercise intervention on other brain structure (white matter integrity), cognitive functions (attention, visual learning, psychomotor function, executive function, verbal learning, working memory and clinician-reported neurological exam outcomes), patient-reported health-related quality of life, objectively measured and patient-reported physical activity level, patient-reported dietary recall, objectively measured physical function assessments, and exercise progression (exercise volume). Assess the agreement between physical function tests performed twice virtually.
- Conditions
- Brain Tumor, Brain Cancer
- Being tested
- Standard Fitbit Program, Virtual Exercise Program
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Fitbit ProgramBehavioural
Participants will be given a Fitbit to wear during their participation in this program. Participants will need to wear the Fitbit at least 5 days per week and for at least 10 hours a day. Participants will take part in video calls (through the video conferencing platform Zoom) 1 time a week.
Virtual Exercise ProgramBehavioural
Participants will be given a Fitbit to wear during their participation in this program. Participants will need to wear the Fitbit at least 5 days per week and for at least 10 hours a day. Participants will take part in video calls (through the video conferencing platform Zoom) 1 time a week.
| Study group | Role | What they receive |
|---|---|---|
| Actigraph | Experimental | A device worn on the waist that measures physical activity (such as the number of steps participants walk each day, how long participants spend standing, and how long partticipants spend laying down). Participants should wear the ActiGraph at least 10 hours a day for 7 days. Receives: Behavioral: Standard Fitbit Program; Behavioral: Virtual Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT)
Scale Score ranges from 0-10
0-Symptom has not been present 10-The symptom was as bad as you can imagine it could be
Measured: Through study completion an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start5 Jun 2023
- Primary completion28 Jul 2025
- Study completion28 Jul 2025
Why it stopped: \<75% participation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria L Schadler, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554159
- Sponsor's protocol ID
- 2022-0152
- Other IDs
- NCI-2022-08000
- Status last verified
- Jul 2025
- First submitted
- 21 Sep 2022
- Last updated
- 1 Aug 2025
- 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 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Virtually Delivered Exercise Intervention To Mitigate Cognitive Deficits From Radiotherapy In AYAs With Brain Tumors
- ClinicalTrials.gov ID
- NCT05554159
- Acronym / sponsor ID
- 2022-0152
- Conditions
- Brain Tumor, Brain Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: \<75% participation
- Enrolment
- 10 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 28 Jul 2025 (actual)
- Study completion
- 28 Jul 2025 (actual)
- First posted
- 26 Sep 2022 (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.
To test a new investigational virtual exercise program for adolescents and young adults (AYAs) with brain tumors who plan to receive cranial radiotherapy
Detailed description
Primary Objective:
Determine the feasibility and acceptability of a virtually supervised exercise intervention compared to control in AYAs with brain tumors undergoing cranial radiotherapy (CRT).
Secondary Objective:
Assess the effect of supervised exercise intervention on the neuroanatomic structure and cognitive function changes in AYAs with brain tumors undergoing CRT.
Exploratory Objective:
Assess the effect of supervised exercise intervention on other brain structure (white matter integrity), cognitive functions (attention, visual learning, psychomotor function, executive function, verbal learning, working memory and clinician-reported neurological exam outcomes), patient-reported health-related quality of life, objectively measured and patient-reported physical activity level, patient-reported dietary recall, objectively measured physical function assessments, and exercise progression (exercise volume). Assess the agreement between physical function tests performed twice virtually.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Actigraph | Experimental | Behavioral: Standard Fitbit Program, Behavioral: Virtual Exercise ProgramA device worn on the waist that measures physical activity (such as the number of steps participants walk each day, how long participants spend standing, and how long partticipants spend laying down). Participants should wear the ActiGraph at least 10 hours a day for 7 days. |
Who may qualify
- Ages
- 15 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Age 15-39 years old
- Self-reported diagnosis of a primary benign or malignant brain tumor or confirmed diagnosis of primary benign or malignant brain tumor radiographically or pathologically when available (relapse or newly diagnosed)
- Plans to receive CRT at MDACC or, if the participant has already started CRT, the participant is eligible if they are within 3 weeks of the start of CRT
- Received appropriate physician clearance
- Able to move arms and legs, and ambulate safely
Key exclusion criteria (10 listed)
- Non-English speaking
- Screen failure for exercise safety based on Physical Activity Readiness Questionnaire (PAR-Q).12
- Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease
- Recent fracture or acute musculoskeletal injury that precludes ability to participate in supervised exercise training sessions
- Cognitive and/or major sensory deficits that would impede the completion of research activities and assessments as deemed by the clinical team.
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 |
|---|---|---|
| Standard Fitbit ProgramParticipants will be given a Fitbit to wear during their participation in this program. Participants will need to wear the Fitbit at least 5 days per week and for at least 10 hours a day. Participants will take part in video calls (through the video conferencing platform Zoom) 1 time a week. | Behavioural | Actigraph |
| Virtual Exercise ProgramParticipants will be given a Fitbit to wear during their participation in this program. Participants will need to wear the Fitbit at least 5 days per week and for at least 10 hours a day. Participants will take part in video calls (through the video conferencing platform Zoom) 1 time a week. | Behavioural | Actigraph |
Primary outcome
MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT)
Time frame: Through study completion an average of 1 year.
Scale Score ranges from 0-10 0-Symptom has not been present 10-The symptom was as bad as you can imagine it could be
Results and safety
The study was stopped early (reason given: \<75% participation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- M D Anderson Cancer CenterLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Maria L Schadler, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Fitbit Program and Virtual Exercise Program in people with Brain Tumor and Brain Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
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 12 inclusion and 10 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: stopped early, as of the sponsor's last update on 1 Aug 2025. 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 United States. 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?
The study was stopped early (reason given: \<75% participation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT) (time frame: Through study completion an average of 1 year.). 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 1 Aug 2025.