Pediatric Brain TumorNCT07094360
Effect of Hydrotherapy on Children With Brain Tumor
A study testing Land-based exercise program and Hydrotherapy besides Land-based exercise program in people with Pediatric Brain Tumor, run by Cairo University.
Trial summary
Background: Brain and spinal cord tumors are the second most common cancers in children (after leukemia). They account for about 1 out of 4 childhood cancers. More than 4,000 central nervous system tumors are diagnosed each year in children and teens. (Blaney et al., 2011). Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Pediatric Brain Tumor
- What is being tested?
- Land-based exercise program and Hydrotherapy besides Land-based exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Apr 2017
- 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 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- They will be selected according to the following criteria:
- Children between 5-14 years old.
- Children after brain tumor resection surgery 4 weeks post-surgery.
Who cannot join
- Children who have one or more of the following criteria will be excluded from the study:
- Children who cannot follow orders or instructions.
- Children with a genetic disorder.
- Children with a chronic lung disease.
- Sever cardiomyopathy (ejection fraction <40%, ischemia and angina pectoris at rest).
- Children with a neuromuscular disease.
About this study
Official title: Effect of Hydrotherapy on Performance in Children With Brain Tumor
- Background: Brain and spinal cord tumors are the second most common cancers in children (after leukemia). They account for about 1 out of 4 childhood cancers. More than 4,000 central nervous system tumors are diagnosed each year in children and teens. (Blaney et al., 2011).
- Aim: It has been reported that those children have easy fatigability so the purpose of this study is to investigate the effectiveness of hydrotherapy on endurance in these Children.
- Significance: The effects of physical exercise training interventions for childhood cancer participants are not yet convincing due to small numbers of participants and insufficient study methodology. More and high-quality evidence is needed in order to be able to draft exercise and physical activity guidelines for this population. Despite the positive results of exercise interventions in adult cancer patients, the evidence for benefits in childhood cancer patients is limited (Braam et al., 2013).
An 8-week deep water exercise program was clinically effective for improving CRF(Cancer-Related-Fatigue), muscle strength, and several aspects of mood state as compared with usual treatment care at short and medium term in breast cancer survivors reporting a moderate rate of fatigue (Irene et al., 2013).
Read more
In this study, the investigators are trying to find out the effect of hydrotherapy as a way of fun and amusement that children can do easily with great pleasure and also as a treatment method.
- Subjects: Thirty children of both sexes will participate in this study. Inclusion criteria: Children between 5-14 years old after brain tumor resection surgery 2 weeks post-surgery. Exclusion Criteria: Cognitive or mental (developmental), or both, impairment, Children with a genetic disorder, Children with a chronic lung disease, Severe cardiomyopathy (ejection fraction <40%, ischemia and angina pectoris at rest), Children with a neuromuscular disease.
- Methodology:
For Evaluation: Lafayette manual muscle tester to assess muscle endurance/strength (Lafayette instrument evaluation, 2015). The pediatric quality of life inventory version 4(PedsQL) is used to assess quality of life (Varni et al., 1999). The nine-minute run-walk test (Guedes et al., 2006) and the timed up-and-down stairs test (Zaino et al., 2004) are to measure Cardiorespiratory fitness.
For Treatment: Children will be divided into two groups, control group will receive a land-exercise program and study group will receive the same exercise program then repetition of these exercises under water to study the effectiveness of using hydrotherapy. The program will take 30 minutes (5 minutes each with 1 minute rest in between).
The selected program will be in the form of:
- Sitting while strengthening shoulder horizontal adductors by using weights.
- Sitting while pushing down by using weights.
- Sitting while strengthening elbow extensors by using weights.
- Sitting while holding weights for a while.
- Standing on uneven surface.
- Pushing downs by legs.
- Sitting balance.
- Sitting with pushing by hands while making legs as glue.
- Sitting with kicking by legs while fixing hands.
- Standing and throwing a ball.
- Weight shifting and recovery while initiating single limb support.
- Conditions
- Pediatric Brain Tumor
- Being tested
- Land-based exercise program, Hydrotherapy besides Land-based exercise program
- Keywords
- Hydrotherapy, Performance, Children, Brain tumor
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Land-based exercise programOther
Land-based exercise program
Hydrotherapy besides Land-based exercise programOther
Hydrotherapy besides Land-based exercise program
| Study group | Role | What they receive |
|---|---|---|
| Land-based exercise program | Experimental | Land-based exercise program Receives: Other: Land-based exercise program |
| Hydrotherapy besides Land-based exercise program | Experimental | Hydrotherapy besides Land-based exercise program Receives: Other: Hydrotherapy besides Land-based exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength of upper and lower limb muscles
Lafayette Manual Muscle Tester:
The test was performed by applying force to the limb of a child as he/she resists the force isometrically. The objective of the test is for the clinician to overcome or "break" the child's resistance. When the resistance "break" occurs the Lafayette Manual Muscle Tester (MMT) records the peak force and the time required to achieve the "break providing reliable, accurate, and stable muscle strength readings that conform to most manual muscle testing protocols. The MMT also features a wide range of customizable options for data storage, preset test times, and force thresholds
Measured: 4-6 months
Secondary outcomes (2)
Pediatric quality of life
The pediatric quality of life inventory version 4 (PedsQL) is a modular approach to measure health-related quality of life in healthy children and adolescents and those with acute and chronic health conditions. The Pads Measurement Model integrates seamlessly both generic core scales and disease-specific modules into one measurement system. The PedsQL Brain tumor module was used in this study.
Measured: 4-6 months
Cardiorespiratory fitness
The Six-minute run-walk test:
This test has been used as an adaptation of the 12-minute Cooper test for children under the age of 12, and is also used in Brazil and internationally as an alternative to motor test batteries for CRF assessment (Gaya et al., 2007). Currently, it becomes modified to the 6-minute walk
Measured: 4-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study startNov 2016
- Primary completionDec 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Brain TumorStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Usama Mahmoud Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094360
- Sponsor's protocol ID
- 2490-2016
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 30 Jul 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 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hydrotherapy on Performance in Children With Brain Tumor
- ClinicalTrials.gov ID
- NCT07094360
- Acronym / sponsor ID
- 2490-2016
- Conditions
- Pediatric Brain Tumor
- Keywords
- Hydrotherapy, Performance, Children, Brain tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 30 Jul 2025 (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.
- Background: Brain and spinal cord tumors are the second most common cancers in children (after leukemia). They account for about 1 out of 4 childhood cancers. More than 4,000 central nervous system tumors are diagnosed each year in children and teens. (Blaney et al., 2011).
- Aim: It has been reported that those children have easy fatigability so the purpose of this study is to investigate the effectiveness of hydrotherapy on endurance in these Children.
- Significance: The effects of physical exercise training interventions for childhood cancer participants are not yet convincing due to small numbers of participants and insufficient study methodology. More and high-quality evidence is needed in order to be able to draft exercise and physical activity guidelines for this population. Despite the positive results of exercise interventions in adult cancer patients, the evidence for benefits in childhood cancer patients is limited (Braam et al., 2013).
An 8-week deep water exercise program was clinically effective for improving CRF(Cancer-Related-Fatigue), muscle strength, and several aspects of mood state as compared with usual treatment care at short and medium term in breast cancer survivors reporting a moderate rate of fatigue (Irene et al., 2013).
In this study, the investigators are trying to find out the effect of hydrotherapy as a way of fun and amusement that children can do easily with great pleasure and also as a treatment method.
- Subjects: Thirty children of both sexes will participate in this study. Inclusion criteria: Children between 5-14 years old after brain tumor resection surgery 2 weeks post-surgery. Exclusion Criteria: Cognitive or mental (developmental), or both, impairment, Children with a genetic disorder, Children with a chronic lung disease, Severe cardiomyopathy (ejection fraction <40%, ischemia and angina pectoris at rest), Children with a neuromuscular disease.
- Methodology:
For Evaluation: Lafayette manual muscle tester to assess muscle endurance/strength (Lafayette instrument evaluation, 2015). The pediatric quality of life inventory version 4(PedsQL) is used to assess quality of life (Varni et al., 1999). The nine-minute run-walk test (Guedes et al., 2006) and the timed up-and-down stairs test (Zaino et al., 2004) are to measure Cardiorespiratory fitness.
For Treatment: Children will be divided into two groups, control group will receive a land-exercise program and study group will receive the same exercise program then repetition of these exercises under water to study the effectiveness of using hydrotherapy. The program will take 30 minutes (5 minutes each with 1 minute rest in between).
The selected program will be in the form of:
- Sitting while strengthening shoulder horizontal adductors by using weights.
- Sitting while pushing down by using weights.
- Sitting while strengthening elbow extensors by using weights.
- Sitting while holding weights for a while.
- Standing on uneven surface.
- Pushing downs by legs.
- Sitting balance.
- Sitting with pushing by hands while making legs as glue.
- Sitting with kicking by legs while fixing hands.
- Standing and throwing a ball.
- Weight shifting and recovery while initiating single limb support.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Land-based exercise program | Experimental | Other: Land-based exercise programLand-based exercise program |
| Hydrotherapy besides Land-based exercise program | Experimental | Other: Hydrotherapy besides Land-based exercise programHydrotherapy besides Land-based exercise program |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children between 5-14 years old.
- Children after brain tumor resection surgery 4 weeks post-surgery.
Key exclusion criteria (6 listed)
- Children who cannot follow orders or instructions.
- Children with a genetic disorder.
- Children with a chronic lung disease.
- Sever cardiomyopathy (ejection fraction <40%, ischemia and angina pectoris at rest).
- Children with a neuromuscular disease.
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 |
|---|---|---|
| Land-based exercise programLand-based exercise program | Other | Land-based exercise program |
| Hydrotherapy besides Land-based exercise programHydrotherapy besides Land-based exercise program | Other | Hydrotherapy besides Land-based exercise program |
Primary outcome
Muscle strength of upper and lower limb muscles
Time frame: 4-6 months
Lafayette Manual Muscle Tester: The test was performed by applying force to the limb of a child as he/she resists the force isometrically. The objective of the test is for the clinician to overcome or "break" the child's resistance. When the resistance "break" occurs the Lafayette Manual Muscle Tester (MMT) records the peak force and the time required to achieve the "break providing reliable, accurate, and stable muscle strength readings that conform to most manual muscle testing protocols. The MMT also features a wide range of customizable options for data storage, preset test times, and force thresholds
2 secondary outcomes
Pediatric quality of life
Time frame: 4-6 months
Cardiorespiratory fitness
Time frame: 4-6 months
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 30 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Land-based exercise program and Hydrotherapy besides Land-based exercise program in people with Pediatric Brain Tumor, run by Cairo University.
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 3 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: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Muscle strength of upper and lower limb muscles (time frame: 4-6 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 30 Jul 2025; AzTrials last refreshed its copy on 6 Nov 2026.