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Effects of Exercises on Total Body Health in Children With Acute Lymphoblastic Leukemia

Primary Purpose

Acute Lymphoblastic Leukemia, Bone Density Increased

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise therapy
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Lymphoblastic Leukemia focused on measuring acute lymphoblastic leukemia, bone density, total fat, exercise

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Bezmialem Vakıf University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

exercise

control

Arm Description

the exercise group will applied virtual reality exercises by Nintendo Wii Fit Plus System Game Console.

No exercise applied the control group.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

total body fat ratios
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
subcutaneous thickness
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
bone mineral densities
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.
markers of bone metabolism
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.

Full Information

First Posted
July 13, 2018
Last Updated
January 14, 2020
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT04015882
Brief Title
Effects of Exercises on Total Body Health in Children With Acute Lymphoblastic Leukemia
Official Title
Effects of Virtual Reality Exercises on Total Body Fat Ratio and Bone Health in Children With Acute Lymphoblastic Leukemia at Remitted
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia, Bone Density Increased
Keywords
acute lymphoblastic leukemia, bone density, total fat, exercise

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
exercise
Arm Type
Active Comparator
Arm Description
the exercise group will applied virtual reality exercises by Nintendo Wii Fit Plus System Game Console.
Arm Title
control
Arm Type
No Intervention
Arm Description
No exercise applied the control group.
Intervention Type
Other
Intervention Name(s)
Exercise therapy
Intervention Description
The exercise therapy group will make by physiotherapist supervision.
Primary Outcome Measure Information:
Title
body mass index
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
total body fat ratios
Description
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
Time Frame
12 weeks
Title
subcutaneous thickness
Description
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
Time Frame
12 weeks
Title
bone mineral densities
Description
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.
Time Frame
12 weeks
Title
markers of bone metabolism
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Bezmialem Vakıf University
City
İstanbul
ZIP/Postal Code
34090
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Exercises on Total Body Health in Children With Acute Lymphoblastic Leukemia

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