Attention Deficit Hyperactivity DisorderNCT03469180
Comparison of Treadmill and Whole Body Vibration Training in Children With Attention Deficit Hyperactivity Disorder
A study testing Treadmill training and Whole body vibration training in people with Attention Deficit Hyperactivity Disorder, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Treadmill training and Whole body vibration training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Mar 2018to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ADHD diagnosis (Previously not taking or not taking medication for ADHD)
- Being going to primary school
Who cannot join
- Having a chronic and serious medical condition
- Seizure-like neurological impairment
- Autism spectrum disorder, vision, speech, hearing problems
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Treadmill training, Whole body vibration training
- Keywords
- Treadmill Training, Whole Body Vibration Training
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill trainingOther
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).
Whole body vibration trainingOther
Whole body vibration training whole body vibration frequence will be 50 Hertz and childrens will be standing position on vibration platform .
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Treadmill training; Other: Whole body vibration training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Eight weeks
Change from baseline sensory integration and balance test score in Biodex Balance System at 8 weeks
Measured: 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
Measured: Eight weeks
Secondary outcomes (4)
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
Measured: Eight weeks
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.
Measured: Eight weeks
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
Measured: Eight weeks
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
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start24 Mar 2018
- Primary completion1 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Collaborators
- Medipol University
- Responsible party
- Principal investigator, Elif Durgut, Bezmialem Vakif University
- Investigators
- Elif Durgut, Msc,PT, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469180
- Sponsor's protocol ID
- bvuedurgut01
- Status last verified
- Jul 2018
- First submitted
- 13 Mar 2018
- Last updated
- 11 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Treadmill and Whole Body Vibration Training in Children With Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT03469180
- Acronym / sponsor ID
- bvuedurgut01
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Treadmill Training, Whole Body Vibration Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Collaborators
- Medipol University
- Study start
- 24 Mar 2018 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 19 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Treadmill trainingChildrens in this group will receive treadmill training, three times a week for 8 weeks. Each season will be supervised and last 45 minutes. |
| Training Group | Experimental | Other: Treadmill training, Other: Whole body vibration trainingİn addition to treadmill training, childrens in this group (after a rest for 5 minutes) will also receive whole body vibration training for 15 minutes. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ADHD diagnosis (Previously not taking or not taking medication for ADHD)
- Being going to primary school
Key exclusion criteria (3 listed)
- Having a chronic and serious medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treadmill trainingTreadmill 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). | Other | Control Group, Training Group |
| Whole body vibration trainingWhole body vibration training whole body vibration frequence will be 50 Hertz and childrens will be standing position on vibration platform . | Other | Training Group |
Primary outcome
Change from baseline postural stability test score in Biodex Balance System at 8 weeks
Time frame: Eight 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.
Change from baseline limits of stability test score in Biodex Balance System at 8 weeks
Time frame: Eight 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
Change from baseline sensory integration and balance test score in Biodex Balance System at 8 weeks
Time frame: Eight weeks
Change from baseline single leg balance test score in Biodex Balance System at 8 weeks
Time frame: Eight weeks
The low stability level of four will challenge subjects and provide the data necessary to assess the subject's single leg postural stability
4 secondary outcomes
Change from baseline Stroop test score at 8 weeks
Time frame: Eight weeks
Change from baseline BRIEF (Behavior Rating Inventory of Executive Function) score at 8 weeks
Time frame: Eight weeks
Change from baseline Conners score at 8 weeks
Time frame: Eight weeks
Change from baseline the Pediatric Quality of Life Inventory (PedsQL) score at 8 weeks
Time frame: Eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elif Durgut, Msc,PT principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill training and Whole body vibration training in people with Attention Deficit Hyperactivity Disorder, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline postural stability test score in Biodex Balance System at 8 weeks (time frame: Eight weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2018.