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

NCT03469180 | Completed

• 1 other identifier: bvuedurgut01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Treadmill Training; Whole Body Vibration Training

Outcome Measures

Primary Outcomes (4)

• 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.

  Eight weeks

• 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

  Eight weeks

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

  Eight weeks

• 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

  Eight weeks

Secondary Outcomes (4)

• Change from baseline Stroop test score at 8 weeks

  Eight weeks

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

  Eight weeks

• Change from baseline Conners score at 8 weeks

  Eight weeks

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

  Eight weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Training Group

EXPERIMENTAL

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

Treadmill training OTHER

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).

Control Group; Training Group

Whole body vibration training OTHER

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

Training Group

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Having a chronic and serious medical condition
• Seizure-like neurological impairment
• Autism spectrum disorder, vision, speech, hearing problems

Sponsors & Collaborators

• Bezmialem Vakif University: lead
• Medipol University: collaborator

Study Sites (1)

Bezmialem Vakıf University

Istanbul, 34060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Elif Durgut, Msc,PT

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer,MSc,PT

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: March 19, 2018
• Study Start: March 24, 2018
• Primary Completion: June 1, 2018
• Study Completion: June 30, 2018
• Last Updated: July 11, 2018

Record last verified: 2018-07

Locations

TU (1)