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

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

Effects of Virtual Reality Exercises on Total Body Fat Ratio and Bone Health in Children With Acute Lymphoblastic Leukemia at Remitted

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04015882
• Other study ID #: BezmialemVUb
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2020
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Bone Density Increased
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Other:
• Exercise therapy
The exercise therapy group will make by physiotherapist supervision.

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	12 weeks
Secondary	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	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks