Brain TumorPhase 2NCT02153957
Trial Evaluating an Enhanced Physical Activity Intervention to Improve Cognitive Late Effects in Children Treated With Cranial Radiation for Brain Tumors
A Phase 2 study testing Physical Activity in people with Brain Tumor, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: More children with cancer are surviving into adulthood. Some side effects from treatment go away quickly. But some problems may not go away or may only show up months or years later. These problems are called late effects. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Brain Tumor
- What is being tested?
- Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2014to 14 Feb 2023
- Phase
- Phase 2
- 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Children ages 8 - 18 years of age, diagnosed with brain tumor in childhood.
- Must be at least 1 year post completion of radiation therapy to the brain or brain and spine.
- Must be off anti-neoplastic therapy for at least 2 weeks and all therapy-related toxicities should return to baseline or less than or equal to Grade 1 if previously nonexistent.
- Have parent-reported or documented difficulties in attention, processing speed, memory, or learning as assessed by the screening questions (a score of at least 3 on any one of the 4 questions or the participant having greater than or equal to 1/2 SD decline in test scores, scores < 85, or special education services or accommodations).
- Must have a parent or legal guardian willing to complete the parent proxy behavioral questionnaires and help their child participate in the study procedures at home.
- Ability to read and understand the English language.
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- Have regular access to a computer a tablet, or a smartphone (the device must have either a USB port or Bluetooth with internet capability).
- Must be willing to register online and install the software to use an age-appropriate activity monitor and website/app which will include sharing some personal identifiable information, to allow the participant to track their physical activity.
- Ability of subject or parent/guardian to understand and willingness to sign a written informed consent document.
- PARENT OR GURADIAN OF PARTICIPATING SUBJECT:
- Parent or Guardian of participating subject
- Ability to understand and willingness to sign a written informed consent document
- Ability to read and understand the English language.
Who cannot join
- A child with diffuse intrinsic pontine glioma (DIPG) or recurrent high grade brain tumors will be excluded due to the poor prognosis, making participation for the length of this study difficult.
- Significant medical problems, such as severe uncontrolled illnesses, or physical impairments that prohibit the child from exercising at moderate to vigorous levels based on the clinical judgment of the examining physician or nurse practitioner.
- Currently engaging in > 3 hours of moderate to vigorous physical activity per week, as reported in the exercise screening questions completed at the pre-study screening evaluation.
- Significant cognitive, behavioral, or emotional impairments as judged by an investigator that would prevent the child from understanding or completing the intervention or assessment measures.
- A child has plans to start a new treatment for attention/memory problems in the next 3 months.
- Currently on or planning to begin active neoplastic therapy, as the side effects may significantly impair ability to participate in physical activity.
Show all 10Show fewer
- Unable or unwilling to travel to NIH or DFCI/BCH for the evaluations.
- History of medical non-compliance or difficulty completing previous required study tasks or visits that suggest the participant would not follow through with the home study procedures.
- PARENT OR GUARDIAN EXCLUSION CRITERIA:
- 1. Parent or guardian of an ineligible subject
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: A Randomized Controlled Trial Evaluating an Enhanced Physical Activity Intervention to Improve Cognitive Late Effects in Children Treated With Cranial Radiation for Brain Tumors
Background:
- More children with cancer are surviving into adulthood. Some side effects from treatment go away quickly. But some problems may not go away or may only show up months or years later. These problems are called late effects. Late effects can cause difficulties in cognitive functions, such as attention and memory. Physical activity has been found to improve the attention and memory skills of children with Attention Deficit Hyperactivity Disorder (ADHD). Researchers want to see if physical activity can help with these cognitive problems in children with brain tumors.
Read more
Objectives:
- To see if physical activity can improve cognitive functions in children who had radiation therapy for a brain tumor.
Eligibility:
- Children ages 8 17 who had radiation for a brain tumor at least 2 years ago. They must have access to a computer.
Design:
- Participants will be screened with height, weight, and medical history. They will answer questions about daily physical activities. Their heart will be checked.
- Participants will go to the clinic for 2 days. They will have a fitness exam and tests about attention, memory, and concentration. They will have blood taken and answer questions. Parents will also answer questions.
- Participants will be put into 2 groups. For the first 12 weeks, the intervention group will follow a physical activity program. The control group will do their usual physical activities.
- For the second 12 weeks, the control group will follow the physical activity program. The intervention group will continue the activities on their own. All groups will track their physical activity with an activity monitor and computer.
- Participants will have a follow-up visit at the clinic after each session. They will repeat some of the tests listed above.
- The study lasts 24 weeks plus the two follow-up visits. Participants can keep their activity monitor.
Read the detailed description
BACKGROUND:
- Children treated with cranial radiation therapy (CRT) for brain tumors are at high risk for developing neurocognitive late effects consisting of significant declines in overall IQ and specific cognitive impairments, particularly in attention, memory, and processing speed. Academic functioning, daily activities, and quality of life (QOL) also are impacted, and children often require special educational services.
- Despite adaptations in radiation therapy (delay of radiation, reduced dose, specialized techniques), cognitive deficits still develop. Interventions targeting cognitive rehabilitation are limited yet sorely needed.
- A potential and novel intervention for cognitive rehabilitation that has not been explored in children with cancer involves physical activity (PA). Compelling evidence from both human and animal studies indicates that PA affects the same brain mechanisms and cognitive functions damaged by CRT and chemotherapy.
- Previous PA intervention studies in children with cancer have been found to be feasible, safe, and beneficial to health but have not examined cognition outcomes. Therefore, we will conduct a randomized controlled trial to evaluate the effects of PA on the cognitive functioning of children treated with CRT for brain tumors. In addition, we will enhance the intervention by combining it with Acceptance and Commitment Therapy (ACT) techniques to maximize participants' motivation to engage in PA.
- The immediate intervention group (the intervention group ) will engage in the enhanced PA intervention program for the first 12 weeks followed by 12 weeks of PA maintenance on their own, while the delayed intervention control group (the control group ) will engage in their usual physical activity for the first 12 weeks followed by the enhanced PA intervention program for the second 12 weeks.
OBJECTIVES:
-To assess the effects of a 12-week enhanced physical activity (PA) home intervention on visual memory (CogState One Card Learning Accuracy score) in children treated with CRT for brain tumors compared to a control group engaged in usual physical activity during the first 12 weeks.
ELIGIBILITY:
- Children ages 8 - 18 years previously diagnosed with a brain tumor in childhood who are at least 1 year post-completion of CRT and who are not on an active anti-tumor treatment will be eligible.
- Children should have reported or documented cognitive difficulties in attention, learning and memory, or processing speed per the child s parent or legal guardian.
DESIGN:
-In this prospective randomized controlled trial. Children will be randomized to one of two groups: Group 1 (n=30): The immediate intervention group (the intervention group ) will participate in the enhanced PA home intervention group for the first 12 weeks; followed by 12 weeks of PA maintenance on their own.
Group 2 (n=30): The delayed intervention control group (the control group ) will engage in their usual physical activity (no intervention) for 12 weeks; followed by the enhanced PA home intervention for 12 weeks.
- Neurobehavioral, circulating growth factors, and cardiorespiratory evaluations will be conducted at baseline (T0) and after the first 12 weeks at home (T2) in both the intervention and control groups. The acute effects of the in-lab PA will be assessed immediately following the baseline treadmill fitness test (T1) using selected cognitive measures in both groups. PA for both groups will be measured throughout the period at home via activity monitors.
- After the completion of the first 12 week period at home and the follow-up evaluations (T2), the intervention group will be asked to maintain their PA levels on their own for the next 12 weeks while the control group will participate in the enhanced PA intervention at home for 12 weeks. A final cognitive evaluation will be conducted in both groups after the completion of the second 12- week period (T3). The primary outcome measure is the Cogstate One Card Learning Accuracy Score. The effects of PA on other neurobehavioral outcomes and circulating growth factors also will be examined.
- Conditions
- Brain Tumor
- Being tested
- Physical Activity
- Keywords
- Exercise, Memory, BDNF, Zamzee, QOL
- Medical subject headings
- Brain Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
12 weeks of enhanced physical activity with Zamzee monitor.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | enhanced PA home intervention group for the first 12 weeks; followed by 12 weeks of PA maintenance on their own. Receives: Behavioral: Physical Activity |
| 2 | Active comparator | usual physical activity (no intervention) for 12 weeks; followed by the enhanced PA home intervention for 12 weeks. Receives: Behavioral: Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Efficacy of 12-weeks PA on visual memory
Measured: 12 weeks
Secondary outcomes (6)
feasibility
To assess the feasibility of various components of the intervention (e.g., ACT sessions, PA monitors) based on the post-study questionnaire/interview and explore relationships between the use of these components and physical activity outcomes
Measured: 4 years
examine test scores pre- to post-intervention
examine test scores pre- to post-intervention
Measured: 24 weeks
effects of lab treadmill on neurobehavioral functioning
effects of lab treadmill on neurobehavorial functioning
Measured: 2 days
effects of 12wk PA on fatigue, sleep and QOL
effects of 12wk PA on fatigue, sleep, and QOL
Measured: 24 weeks
effects of 12wk PA on cognitive functions
effects of 12wk PA on cognitive functions
Measured: 24 weeks
compare cognitive test scores between groups
compare cognitive test scores between groups
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study start21 Aug 2014
- Primary completion14 Feb 2023
- Study completion14 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Pamela L Wolters, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153957
- Sponsor's protocol ID
- 140116
- Other IDs
- 14-C-0116
- Status last verified
- 10 Jul 2026
- First submitted
- 31 May 2014
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request.
Publications
Naylor AS, Bull C, Nilsson MK, Zhu C, Bjork-Eriksson T, Eriksson PS, Blomgren K, Kuhn HG. Voluntary running rescues adult hippocampal neurogenesis after irradiation of the young mouse brain. Proc Natl Acad Sci U S A. 2008 Sep 23;105(38):14632-7. doi: 10.1073/pnas.0711128105. Epub 2008 Sep 2.
PubMed 18765809Gapin JI, Labban JD, Etnier JL. The effects of physical activity on attention deficit hyperactivity disorder symptoms: the evidence. Prev Med. 2011 Jun;52 Suppl 1:S70-4. doi: 10.1016/j.ypmed.2011.01.022. Epub 2011 Jan 31.
PubMed 21281664Butryn ML, Forman E, Hoffman K, Shaw J, Juarascio A. A pilot study of acceptance and commitment therapy for promotion of physical activity. J Phys Act Health. 2011 May;8(4):516-22. doi: 10.1123/jpah.8.4.516.
PubMed 21597124
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
- A Randomized Controlled Trial Evaluating an Enhanced Physical Activity Intervention to Improve Cognitive Late Effects in Children Treated With Cranial Radiation for Brain Tumors
- ClinicalTrials.gov ID
- NCT02153957
- Acronym / sponsor ID
- 140116
- Conditions
- Brain Tumor
- Keywords
- Exercise, Memory, BDNF, Zamzee, QOL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 21 Aug 2014 (actual)
- Primary completion
- 14 Feb 2023 (actual)
- Study completion
- 14 Feb 2023 (actual)
- First posted
- 3 Jun 2014 (estimated)
- 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.
Background:
- More children with cancer are surviving into adulthood. Some side effects from treatment go away quickly. But some problems may not go away or may only show up months or years later. These problems are called late effects. Late effects can cause difficulties in cognitive functions, such as attention and memory. Physical activity has been found to improve the attention and memory skills of children with Attention Deficit Hyperactivity Disorder (ADHD). Researchers want to see if physical activity can help with these cognitive problems in children with brain tumors.
Objectives:
- To see if physical activity can improve cognitive functions in children who had radiation therapy for a brain tumor.
Eligibility:
- Children ages 8 17 who had radiation for a brain tumor at least 2 years ago. They must have access to a computer.
Design:
- Participants will be screened with height, weight, and medical history. They will answer questions about daily physical activities. Their heart will be checked.
- Participants will go to the clinic for 2 days. They will have a fitness exam and tests about attention, memory, and concentration. They will have blood taken and answer questions. Parents will also answer questions.
- Participants will be put into 2 groups. For the first 12 weeks, the intervention group will follow a physical activity program. The control group will do their usual physical activities.
- For the second 12 weeks, the control group will follow the physical activity program. The intervention group will continue the activities on their own. All groups will track their physical activity with an activity monitor and computer.
- Participants will have a follow-up visit at the clinic after each session. They will repeat some of the tests listed above.
- The study lasts 24 weeks plus the two follow-up visits. Participants can keep their activity monitor.
Detailed description
BACKGROUND:
- Children treated with cranial radiation therapy (CRT) for brain tumors are at high risk for developing neurocognitive late effects consisting of significant declines in overall IQ and specific cognitive impairments, particularly in attention, memory, and processing speed. Academic functioning, daily activities, and quality of life (QOL) also are impacted, and children often require special educational services.
- Despite adaptations in radiation therapy (delay of radiation, reduced dose, specialized techniques), cognitive deficits still develop. Interventions targeting cognitive rehabilitation are limited yet sorely needed.
- A potential and novel intervention for cognitive rehabilitation that has not been explored in children with cancer involves physical activity (PA). Compelling evidence from both human and animal studies indicates that PA affects the same brain mechanisms and cognitive functions damaged by CRT and chemotherapy.
- Previous PA intervention studies in children with cancer have been found to be feasible, safe, and beneficial to health but have not examined cognition outcomes. Therefore, we will conduct a randomized controlled trial to evaluate the effects of PA on the cognitive functioning of children treated with CRT for brain tumors. In addition, we will enhance the intervention by combining it with Acceptance and Commitment Therapy (ACT) techniques to maximize participants' motivation to engage in PA.
- The immediate intervention group (the intervention group ) will engage in the enhanced PA intervention program for the first 12 weeks followed by 12 weeks of PA maintenance on their own, while the delayed intervention control group (the control group ) will engage in their usual physical activity for the first 12 weeks followed by the enhanced PA intervention program for the second 12 weeks.
OBJECTIVES:
-To assess the effects of a 12-week enhanced physical activity (PA) home intervention on visual memory (CogState One Card Learning Accuracy score) in children treated with CRT for brain tumors compared to a control group engaged in usual physical activity during the first 12 weeks.
ELIGIBILITY:
- Children ages 8 - 18 years previously diagnosed with a brain tumor in childhood who are at least 1 year post-completion of CRT and who are not on an active anti-tumor treatment will be eligible.
- Children should have reported or documented cognitive difficulties in attention, learning and memory, or processing speed per the child s parent or legal guardian.
DESIGN:
-In this prospective randomized controlled trial. Children will be randomized to one of two groups: Group 1 (n=30): The immediate intervention group (the intervention group ) will participate in the enhanced PA home intervention group for the first 12 weeks; followed by 12 weeks of PA maintenance on their own.
Group 2 (n=30): The delayed intervention control group (the control group ) will engage in their usual physical activity (no intervention) for 12 weeks; followed by the enhanced PA home intervention for 12 weeks.
- Neurobehavioral, circulating growth factors, and cardiorespiratory evaluations will be conducted at baseline (T0) and after the first 12 weeks at home (T2) in both the intervention and control groups. The acute effects of the in-lab PA will be assessed immediately following the baseline treadmill fitness test (T1) using selected cognitive measures in both groups. PA for both groups will be measured throughout the period at home via activity monitors.
- After the completion of the first 12 week period at home and the follow-up evaluations (T2), the intervention group will be asked to maintain their PA levels on their own for the next 12 weeks while the control group will participate in the enhanced PA intervention at home for 12 weeks. A final cognitive evaluation will be conducted in both groups after the completion of the second 12- week period (T3). The primary outcome measure is the Cogstate One Card Learning Accuracy Score. The effects of PA on other neurobehavioral outcomes and circulating growth factors also will be examined.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Physical Activityenhanced PA home intervention group for the first 12 weeks; followed by 12 weeks of PA maintenance on their own. |
| 2 | Active comparator | Behavioral: Physical Activityusual physical activity (no intervention) for 12 weeks; followed by the enhanced PA home intervention for 12 weeks. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Parent or Guardian of participating subject
- Ability to understand and willingness to sign a written informed consent document
- Ability to read and understand the English language.
Key exclusion criteria (10 listed)
- A child with diffuse intrinsic pontine glioma (DIPG) or recurrent high grade brain tumors will be excluded due to the poor prognosis, making participation for the length of this study difficult.
- Significant medical problems, such as severe uncontrolled illnesses, or physical impairments that prohibit the child from exercising at moderate to vigorous levels based on the clinical judgment of the examining physician or nurse practitioner.
- Currently engaging in > 3 hours of moderate to vigorous physical activity per week, as reported in the exercise screening questions completed at the pre-study screening evaluation.
- Significant cognitive, behavioral, or emotional impairments as judged by an investigator that would prevent the child from understanding or completing the intervention or assessment measures.
- A child has plans to start a new treatment for attention/memory problems in the next 3 months.
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 |
|---|---|---|
| Physical Activity12 weeks of enhanced physical activity with Zamzee monitor. | Behavioural | 1, 2 |
Primary outcome
Efficacy
Time frame: 12 weeks
Efficacy of 12-weeks PA on visual memory
6 secondary outcomes
feasibility
Time frame: 4 years
examine test scores pre- to post-intervention
Time frame: 24 weeks
effects of lab treadmill on neurobehavioral functioning
Time frame: 2 days
effects of 12wk PA on fatigue, sleep and QOL
Time frame: 24 weeks
effects of 12wk PA on cognitive functions
Time frame: 24 weeks
compare cognitive test scores between groups
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 18765809Naylor AS, Bull C, Nilsson MK, Zhu C, Bjork-Eriksson T, Eriksson PS, Blomgren K, Kuhn HG. Voluntary running rescues adult hippocampal neurogenesis after irradiation of the young mouse brain. Proc Natl Acad Sci U S A. 2008 Sep 23;105(38):14632-7. doi: 10.1073/pnas.0711128105. Epub 2008 Sep 2.
- Background: PubMed 21281664Gapin JI, Labban JD, Etnier JL. The effects of physical activity on attention deficit hyperactivity disorder symptoms: the evidence. Prev Med. 2011 Jun;52 Suppl 1:S70-4. doi: 10.1016/j.ypmed.2011.01.022. Epub 2011 Jan 31.
- Background: PubMed 21597124Butryn ML, Forman E, Hoffman K, Shaw J, Juarascio A. A pilot study of acceptance and commitment therapy for promotion of physical activity. J Phys Act Health. 2011 May;8(4):516-22. doi: 10.1123/jpah.8.4.516.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request.
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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.
Pamela L Wolters, Ph.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Physical Activity in people with Brain Tumor, run by National Cancer Institute (NCI) 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 13 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: finished, 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02153957, which also lists 3 linked publications.
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.