Effects of Exercises on Total Body Health in Children With Acute Lymphoblastic Leukemia
Effects of Virtual Reality Exercises on Total Body Fat Ratio and Bone Health in Children With Acute Lymphoblastic Leukemia at Remitted
1 other identifier
interventional
20
1 country
1
Brief Summary
In recent years, the survival of patients has increased with the success of leukemia treatment in children. However, according to the treatment modalities applied, complications such as changes in body composition such as obesity, osteoporosis and impaired bone health such as increased fragility are more frequent after treatment in patients.In this study, virtual reality exercise practices in remission of acute lymphoblastic leukemia cases will prevent negative effects on bone health and body composition and increase the quality of life of patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2019
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
July 13, 2018
CompletedFirst Posted
Study publicly available on registry
July 11, 2019
CompletedStudy Start
First participant enrolled
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedJanuary 18, 2020
January 1, 2020
2 months
July 13, 2018
January 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
body mass index
Weight status among children and adolescents aged 2 through 19 years is defined based on BMI. In children and adolescents, overweight is defined as at or above the sex-specific 85th percentile on the CDC's 2000 BMI-for-age growth charts but less than the 95th percentile; obesity is defined as a BMI at or above the sex-specific 95th percentile.
12 weeks
Secondary Outcomes (4)
total body fat ratios
12 weeks
subcutaneous thickness
12 weeks
bone mineral densities
12 weeks
markers of bone metabolism
12 weeks
Study Arms (2)
exercise
ACTIVE COMPARATORthe exercise group will applied virtual reality exercises by Nintendo Wii Fit Plus System Game Console.
control
NO INTERVENTIONNo exercise applied the control group.
Interventions
Eligibility Criteria
You may qualify if:
- Treatment for acute lymphoblastic leukemia
- At remitted term
- Being between 3 and 18 years
- Healthy cases of age and gender control group cases
You may not qualify if:
- Smaller than 3 years old and older than 18 years old
- Having a chronic illness
- Any drug use
- Any developmental anomaly
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bezmialem Vakıf University
Istanbul, 34090, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2018
First Posted
July 11, 2019
Study Start
August 1, 2019
Primary Completion
September 30, 2019
Study Completion
December 31, 2019
Last Updated
January 18, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share