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CompletedNCT03469180Updated Jul 11, 2018

Comparison of Treadmill and Whole Body Vibration Training in Children With Attention Deficit Hyperactivity Disorder

An interventional study of Treadmill training and Whole body vibration training in Attention Deficit Hyperactivity Disorder, sponsored by Bezmialem Vakif University. Completed at 1 site in Turkey. Open to participants aged 7 Years to 11 Years. Per ClinicalTrials.gov, last updated 2018-07-11.

Sponsored by Bezmialem Vakif University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
7 Years to 11 Years
Sex
All
01

Study summary

It is reported in the literature that children with attention deficit hyperactivity disorder (ADHD) may have executive function deficits, impaired social functions, emotional dysregulation, behavioral disorders and motor impairments. Furthermore, studies have shown that exercise, such as acute and chronic aerobic exercises and acute whole body vibration training, improves executive functions and motor abilities and so it is hypothesized that exercise may have a potential or additional treatment option for children with ADHD. Neurobiological researches have already proven the effects on brain changes during exercise and in the case of ADHD, increasing levels of serotonin, dopamine, and norepinephrine within the front striatal lobes of the brain were highlighted when discussing the effects on this neurodevelopmental disorder. The literature emphasizes the importance of physical activity in children with ADHD, but there is no clarity regarding the frequency, intensity or duration of the exercise. Thus, the aim of this study was to investigate and compare the effects of treadmill training as an aerobic exercise and whole body vibration training on executive functions and balance in children with ADHD.

02

Conditions studied

  • Attention Deficit Hyperactivity Disorder

Keywords

  • Treadmill Training
  • Whole Body Vibration Training
03

Who can participate

Ages eligible
7 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ADHD diagnosis (Previously not taking or not taking medication for ADHD)
  • Being going to primary school

Exclusion criteria

Exclusion Criteria:

  • Having a chronic and serious medical condition

    • Seizure-like neurological impairment
    • Autism spectrum disorder, vision, speech, hearing problems
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    Control Group

    Childrens in this group will receive treadmill training, three times a week for 8 weeks. Each season will be supervised and last 45 minutes.

    Other: Treadmill training

  • Experimental
    Training Group

    İn addition to treadmill training, childrens in this group (after a rest for 5 minutes) will also receive whole body vibration training for 15 minutes.

    Other: Treadmill training · Other: Whole body vibration training

Interventions

  • OtherTreadmill training

    Treadmill training Each season will be supervised and last 45 minutes. Treadmill speed will be adjusted to the child's maximal heart rate (MHR) (between 65 to 75 percent of the MHR).

  • OtherWhole body vibration training

    Whole body vibration training whole body vibration frequence will be 50 Hertz and childrens will be standing position on vibration platform .

05

What researchers measure

Primary outcomes

  1. Change from baseline postural stability test score in Biodex Balance System at 8 weeks

    The Postural Stability Training mode is designed to emphasize specific movement patterns or strategies by placing markers anywhere on the screen grid. The patient's score is a tally of how many times the patient can touch targets with the on-screen cursor during any session. Time counts up or down as set.The Postural Stability Test emphasizes a patient's ability to maintain center of balance. The patient's score on this test assesses deviations from center, thus a lower score is more desirable than a higher score.

    Time frame: Eight weeks

  2. Change from baseline limits of stability test score in Biodex Balance System at 8 weeks

    The Limits of Stability Training screen is designed to challenge the user to move through a movement pattern consistent with the sway envelope.This test challenges patients to move and control their center of gravity within their base of support. During each test trial, patients must shift their weight to move the cursor from the center target to a blinking target and back as quickly and with as little deviation as possible. The same process is repeated for each of nine targets

    Time frame: Eight weeks

  3. Change from baseline sensory integration and balance test score in Biodex Balance System at 8 weeks

    Time frame: Eight weeks

  4. Change from baseline single leg balance test score in Biodex Balance System at 8 weeks

    The low stability level of four will challenge subjects and provide the data necessary to assess the subject's single leg postural stability

    Time frame: Eight weeks

Secondary outcomes

  1. Change from baseline Stroop test score at 8 weeks

    This test assesses the response inhibition and measures the ability to shift perceptual set in accordance with changing demands. It also measures the inhibition of a habitual behavior pattern and behaving in an unusual manner. Defects in these abilities result in lack of perseveration, stereotypic behaviors, and difficulty in controlling behavior. These functions are mainly controlled by the frontal lobes. Higher interference scores indicate poorer performance. This test has been adapted and standardized for the Turkish population

    Time frame: Eight weeks

  2. Change from baseline BRIEF (Behavior Rating Inventory of Executive Function) score at 8 weeks

    İt assesses executive function and self-regulation in children and teens. High scores indicate a higher level of dysfunction in a specific domain of executive functions.

    Time frame: Eight weeks

  3. Change from baseline Conners score at 8 weeks

    The scale has been used for the identification of behaviour disorders in children. Higher scores describe more severe behaviour disorder

    Time frame: Eight weeks

  4. Change from baseline the Pediatric Quality of Life Inventory (PedsQL) score at 8 weeks

    The Pediatric Quality of Life Inventory (PedsQL) is a modular instrument for measuring health related quality of life of 2-18 year-old-children. Higher scores indicate higher health-related quality of life

    Time frame: Eight weeks

06

Study locations

1 site
  • Bezmialem Vakıf University
    Istanbul, 34060, Turkey
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03469180
Lead sponsor
Bezmialem Vakif University
Collaborators
Medipol University
Responsible party
Elif Durgut (Lecturer,MSc,PT, Bezmialem Vakif University) — Principal investigator
First posted
Mar 19, 2018
Start date
Mar 24, 2018
Primary completion
Jun 1, 2018
Completion
Jun 30, 2018
Last update
Jul 11, 2018

Study contacts

Elif Durgut, Msc,PT
principal investigator · Bezmialem Vakif University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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