Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-30 @ 10:18 AM
Study NCT ID:
NCT07094360
Status:
COMPLETED
Last Update Posted:
2025-07-30
First Post:
2025-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Hydrotherapy on Children With Brain Tumor
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
Effect of Hydrotherapy on Performance in Children With Brain Tumor
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
1. Sitting while strengthening shoulder horizontal adductors by using weights.
2. Sitting while pushing down by using weights.
3. Sitting while strengthening elbow extensors by using weights.
4. Sitting while holding weights for a while.
5. Standing on uneven surface.
6. Pushing downs by legs.
7. Sitting balance.
8. Sitting with pushing by hands while making legs as glue.
9. Sitting with kicking by legs while fixing hands.
10. Standing and throwing a ball.
11. Weight shifting and recovery while initiating single limb support.
* 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:
1. Sitting while strengthening shoulder horizontal adductors by using weights.
2. Sitting while pushing down by using weights.
3. Sitting while strengthening elbow extensors by using weights.
4. Sitting while holding weights for a while.
5. Standing on uneven surface.
6. Pushing downs by legs.
7. Sitting balance.
8. Sitting with pushing by hands while making legs as glue.
9. Sitting with kicking by legs while fixing hands.
10. Standing and throwing a ball.
11. Weight shifting and recovery while initiating single limb support.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: