Clinical trial · Interventional
A Virtually Delivered Exercise Intervention To Mitigate Cognitive Deficits From Radiotherapy In AYAs With Brain Tumors
NCT05554159CI-TRIAL-00092952terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): \<75% participation
Summary
Brief summary (as posted)
To test a new investigational virtual exercise program for adolescents and young adults (AYAs) with brain tumors who plan to receive cranial radiotherapy
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Cancer | Malignant Brain Neoplasm | ALIAS | 0.90 |
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard Fitbit Program | Behavioral | — | UNRESOLVED |
| Virtual Exercise Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Actigraph
- description
- 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.
- interventionNames
- Behavioral: Standard Fitbit Program
- Behavioral: Virtual Exercise Program
Primary outcomes (1)
- measure
- MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT)
- timeFrame
- Through study completion an average of 1 year.
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 39 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 15-39 years old 2. 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) 3. 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 4. Received appropriate physician clearance 5. Able to move arms and legs, and ambulate safely 6. Participant is insufficiently active (reports less than 150 minutes of planned moderate-vigorous intensity activity per week in the prior week) 7. Participants and/or guardians are willing and able to provide informed consent 8. Has a smartphone with available space to download additional apps 9. Does not have sensorimotor strip impairment as indicated by the clinical team 10. Has internet access 11. Can receive physical therapy because this is part of the standard of care 12. 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. Exclusion Criteria: 1. Non-English speaking 2. Screen failure for exercise safety based on Physical Activity Readiness Questionnaire (PAR-Q).12 3. Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease 4. Recent fracture or acute musculoskeletal injury that precludes ability to participate in supervised exercise training sessions 5. Cognitive and/or major sensory deficits that would impede the completion of research activities and assessments as deemed by the clinical team. 6. Self-reported diagnosis of a metastatic brain tumor or confirmed diagnosis of a metastatic brain tumor radiographically or pathologically when available 7. Self-report of pregnancy 8. Currently enrolled in another physical activity or exercise intervention 9. Prisoners 10. Self-reported pregnancy status
References
Publications (0)
Data not yet available
No reference posted for this study.