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CompletedNCT04015882Updated Jan 18, 2020

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

An interventional study of Exercise therapy in Acute Lymphoblastic Leukemia and Bone Density Increased, sponsored by Bezmialem Vakif University. Completed at 1 site in Turkey. Open to participants aged 3 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-18.

Sponsored by Bezmialem Vakif University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
3 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acute Lymphoblastic Leukemia
  • Bone Density Increased

Keywords

  • acute lymphoblastic leukemia
  • bone density
  • total fat
  • exercise
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 20 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Bezmialem Vakif University is the lead sponsor of 345 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Smaller than 3 years old and older than 18 years old
  • Having a chronic illness
  • Any drug use
  • Any developmental anomaly
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    exercise

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

    Other: Exercise therapy

  • No intervention
    control

    No exercise applied the control group.

Interventions

  • OtherExercise therapy

    The exercise therapy group will make by physiotherapist supervision.

06

What researchers measure

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.

    Time frame: 12 weeks

Secondary outcomes

  1. 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

    Time frame: 12 weeks

  2. 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

    Time frame: 12 weeks

  3. 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.

    Time frame: 12 weeks

  4. 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.

    Time frame: 12 weeks

07

Study locations

1 site
  • Bezmialem Vakıf University
    İstanbul, 34090, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04015882
Lead sponsor
Bezmialem Vakif University
Responsible party
Sponsor
First posted
Jul 11, 2019
Start date
Aug 1, 2019
Primary completion
Sep 30, 2019
Completion
Dec 31, 2019
Last update
Jan 18, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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