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NCT Number: NCT04015882

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

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.

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Key information

Conditions

Acute Lymphoblastic Leukemia Behavior Bone Density Increased Bone Diseases Bone Diseases, Developmental Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Motor Activity Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Osteochondrodysplasias Osteosclerosis Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakıf University

Istanbul, 34090, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise therapy

Other

The exercise therapy group will make by physiotherapist supervision.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 11, 2019
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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