- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04015882
Effects of Exercises on Total Body Health in Children With Acute Lymphoblastic Leukemia
January 14, 2020 updated by: Bezmialem Vakif University
Effects of Virtual Reality Exercises on Total Body Fat Ratio and Bone Health in Children With Acute Lymphoblastic Leukemia at Remitted
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Treatment and intervention options are being tried to avoid such complications that affect the quality of life of patients and there is still no standard treatment to convert bone health to healthy bone structure before the disease.
There is a positive effect of improving the bone health of the activity and exercise programs.
In this study, it was planned to demonstrate the positive effects of these changes on bone health through changes of adipokines and myokins released from fat and muscle tissue by virtual reality exercise method.
Thus, the quality of life can be increased and cancer complications can be reduced in cancer cases.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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İstanbul, Turkey, 34090
- Bezmialem Vakıf University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Treatment for acute lymphoblastic leukemia
- At remitted term
- Being between 3 and 18 years
- Healthy cases of age and gender control group cases
Exclusion Criteria:
- Smaller than 3 years old and older than 18 years old
- Having a chronic illness
- Any drug use
- Any developmental anomaly
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: exercise
the exercise group will applied virtual reality exercises by Nintendo Wii Fit Plus System Game Console.
|
The exercise therapy group will make by physiotherapist supervision.
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No Intervention: control
No exercise applied the control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
body mass index
Time Frame: 12 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
total body fat ratios
Time Frame: 12 weeks
|
The methods have not been extensively studied in children.
The method which provides the most useful measure of fat distribution remains to be determined.
Dual-energy x-ray absorptiometry (DEXA) has been shown to be a reliable and accurate method of measuring fat mass
|
12 weeks
|
subcutaneous thickness
Time Frame: 12 weeks
|
Anthropometric measures such as waist circumference provide simple means of estimating fat distribution that supplement measures of excess adiposity such as BMI, but ultimately cannot definitively differentiate between visceral and subcutaneous adipose tissue
|
12 weeks
|
bone mineral densities
Time Frame: 12 weeks
|
Complications such as growth hormone deficiency and musculoskeletal deformity have negative effects on bone metabolism.
Low bone mineral density is associated with fractures, skeletal deformity, pain, and substantial financial burden not only for childhood cancer survivors but also for public health care systems.
|
12 weeks
|
markers of bone metabolism
Time Frame: 12 weeks
|
Normal pediatric reference ranges for serum markers of bone formation and resorption are a prerequisite for the assessment of metabolic bone disorders and for the monitoring of antiresorptive therapy or disease progression.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2019
Primary Completion (Actual)
September 30, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
July 13, 2018
First Submitted That Met QC Criteria
July 10, 2019
First Posted (Actual)
July 11, 2019
Study Record Updates
Last Update Posted (Actual)
January 18, 2020
Last Update Submitted That Met QC Criteria
January 14, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Musculoskeletal Diseases
- Bone Diseases
- Bone Diseases, Developmental
- Osteochondrodysplasias
- Leukemia
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Lymphoid
- Osteosclerosis
Other Study ID Numbers
- BezmialemVUb
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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