NCT07094360

Brief 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).
  • 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
8.3 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 30, 2025

Completed
Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

1 month

First QC Date

July 21, 2025

Last Update Submit

July 28, 2025

Conditions

Keywords

HydrotherapyPerformanceChildrenBrain tumor

Outcome Measures

Primary Outcomes (1)

  • 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

    4-6 months

Secondary Outcomes (2)

  • Pediatric quality of life

    4-6 months

  • Cardiorespiratory fitness

    4-6 months

Study Arms (2)

Land-based exercise program

EXPERIMENTAL

Land-based exercise program

Other: Land-based exercise program

Hydrotherapy besides Land-based exercise program

EXPERIMENTAL

Hydrotherapy besides Land-based exercise program

Other: Hydrotherapy besides Land-based exercise program

Interventions

Land-based exercise program

Land-based exercise program

Hydrotherapy besides Land-based exercise program

Hydrotherapy besides Land-based exercise program

Eligibility Criteria

Age5 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer at Pediatric department, Faculty of Physical Therapy, Cairo University.

Study Record Dates

First Submitted

July 21, 2025

First Posted

July 30, 2025

Study Start

November 1, 2016

Primary Completion

December 1, 2016

Study Completion

April 1, 2017

Last Updated

July 30, 2025

Record last verified: 2025-07