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出境医 / 临床实验 / Effects of Exercises on Total Body Health in Children With Acute Lymphoblastic Leukemia

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

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.

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Bone Density Increased Other: Exercise therapy Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Virtual Reality Exercises on Total Body Fat Ratio and Bone Health in Children With Acute Lymphoblastic Leukemia at Remitted
Actual Study Start Date : August 1, 2019
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : December 31, 2019
Arms and Interventions
Arm Intervention/treatment
Active Comparator: exercise
the exercise group will applied virtual reality exercises by Nintendo Wii Fit Plus System Game Console.
 Other: Exercise therapy
The exercise therapy group will make by physiotherapist supervision.
No Intervention: control
No exercise applied the control group.
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Locations
Layout table for location information
Turkey
Bezmialem Vakıf University
İstanbul, Turkey, 34090
Sponsors and Collaborators
Bezmialem Vakif University
Tracking Information
First Submitted Date  ICMJE July 13, 2018
First Posted Date  ICMJE July 11, 2019
Last Update Posted Date January 18, 2020
Actual Study Start Date  ICMJE August 1, 2019
Actual Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2019)
  • 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
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Exercises on Total Body Health in Children With Acute Lymphoblastic Leukemia
Official Title  ICMJE Effects of Virtual Reality Exercises on Total Body Fat Ratio and Bone Health in Children With Acute Lymphoblastic Leukemia at Remitted
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Acute Lymphoblastic Leukemia
  • Bone Density Increased
Intervention  ICMJE Other: Exercise therapy
The exercise therapy group will make by physiotherapist supervision.
Study Arms  ICMJE
  • Active Comparator: exercise
    the exercise group will applied virtual reality exercises by Nintendo Wii Fit Plus System Game Console.
    Intervention: Other: Exercise therapy
  • No Intervention: control
    No exercise applied the control group.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 10, 2019) 		20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2019
Actual Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04015882
Other Study ID Numbers  ICMJE BezmialemVUb
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bezmialem Vakif University
Study Sponsor  ICMJE Bezmialem Vakif University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bezmialem Vakif University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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