NCT04707040

Brief Summary

The effects of Neurocognitive Exercise Program (NEP) on ADHD symptoms and executive functions in children with Attention Deficit and Hyperactivity Disorder (ADHD) will be investigated using The Conners parent rating scale-revised short (CPRS-RS), Stroop Test, Wisconsin test and Y-Balance test.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2020

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 11, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2021

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

2 years

First QC Date

January 11, 2021

Last Update Submit

January 16, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Stroop color-word test

    The Stroop Color-Word Test is a color-word task assessing executive function involving processing speed, concentration, and attention (Stroop, 1935). Stroop Test was applied in five sections. These sections and related cards are as follows in their application order: (1) The card with the color names printed in black (1st card), (2) the card with the color names printed in different colors (2nd card), (3) the card with the colored printed circles (3rd card), (4) in the card with neutral words without the color name (4th Card), (5) The section where the colors of the words in the 2nd Card are spelled, with the names of colors printed in different colors. Stroop test gives information about many cognitive processes such as selective attention, focused attention, response inhibition, interference control, and information processing speed.

    12 months

  • Conners parent rating scale-revised short (CPRS-RS)

    CPRS-RS is a 27-item scale that determines the severity of ADHD. The items consist of three sub-scales (Disagree-QA, Cognitive Problems-Inattention CP-I, Hyperactivity-HI) and an auxiliary scale (ADHD Index). The questions are answered by the parents on a four-point Likert scale. "Never", "rarely", "often" and "always" options are scored as "0", "1", "2" and "3" respectively

    12 months

Secondary Outcomes (2)

  • Wisconsin Card Sorting Test (WCST)

    12 months

  • Y-Balance test

    12 months

Study Arms (1)

Neurocognitive Exercise Program Group

EXPERIMENTAL

The group received NEP for 10 weeks, one hour per week conducted by the same physiotherapist with 6 years of experience in this field. Children with ADHD were given home exercises for the other six days of the week without a NEP session. Home exercises were followed with an exercise diary under the control of children's parents. The home exercise program consisted of visual-motor and auditory-motor coordination tasks (daily 15 min).

Other: Neurocognitive Exercise Program

Interventions

Neurocognitive Exercise Program (NEP) is defined as a multimodal exercise program including different motor coordination exercises and cognitive tasks. Exercise progression is performed from easy to difficult, and consist of simple and complex tasks. Different sports equipment (such as different sizes of balls, racket, tulle, pilates ball, eye band, rope, etc.) is used in motor coordination exercises where multiple extremities can be used in NEP. These materials are used during different exercises including cross-limb movements, throwing, jumping, walking, involving different cognitive tasks. The cognitive task used and the degree of difficulty of the task are provided by different visual (colored cards, numbered cards, gestures, etc.) or auditory (keywords, ring signal, etc.) signs. For example, showing a red card might indicate throwing a ball with the left hand, while showing a blue card indicates throwing a ball with the right hand and walking forward

Neurocognitive Exercise Program Group

Eligibility Criteria

Age7 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children between 7-13 years old
  • Diagnosis of ADHD given by an experienced child psychiatrist based on the 5th edition of Diagnostic and Statistical Manual of Mental Disorders (American Psychiatric Association, 2013)

You may not qualify if:

  • Presence of anxiety,
  • Presence of depression,
  • Presence of learning disability,
  • Presence of intellectual disability,
  • Presence of visual impairment,
  • Presence of musculoskeletal or neurological disorders that may directly affect motor skill and cognition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University

Izmir, Narlıdere, 35320, Turkey (Türkiye)

Location

Related Publications (9)

  • Chambers WJ, Puig-Antich J, Hirsch M, Paez P, Ambrosini PJ, Tabrizi MA, Davies M. The assessment of affective disorders in children and adolescents by semistructured interview. Test-retest reliability of the schedule for affective disorders and schizophrenia for school-age children, present episode version. Arch Gen Psychiatry. 1985 Jul;42(7):696-702. doi: 10.1001/archpsyc.1985.01790300064008.

    PMID: 4015311BACKGROUND
  • Christiansen L, Beck MM, Bilenberg N, Wienecke J, Astrup A, Lundbye-Jensen J. Effects of Exercise on Cognitive Performance in Children and Adolescents with ADHD: Potential Mechanisms and Evidence-based Recommendations. J Clin Med. 2019 Jun 12;8(6):841. doi: 10.3390/jcm8060841.

    PMID: 31212854BACKGROUND
  • Diedrichsen J, Criscimagna-Hemminger SE, Shadmehr R. Dissociating timing and coordination as functions of the cerebellum. J Neurosci. 2007 Jun 6;27(23):6291-301. doi: 10.1523/JNEUROSCI.0061-07.2007.

    PMID: 17554003BACKGROUND
  • Goetz M, Schwabova JP, Hlavka Z, Ptacek R, Surman CB. Dynamic balance in children with attention-deficit hyperactivity disorder and its relationship with cognitive functions and cerebellum. Neuropsychiatr Dis Treat. 2017 Mar 21;13:873-880. doi: 10.2147/NDT.S125169. eCollection 2017.

    PMID: 28356743BACKGROUND
  • Greve KW, Ingram F, Bianchini KJ. Latent structure of the Wisconsin Card Sorting Test in a clinical sample. Arch Clin Neuropsychol. 1998 Oct;13(7):597-609.

    PMID: 14590620BACKGROUND
  • Kaufman J, Birmaher B, Brent D, Rao U, Flynn C, Moreci P, Williamson D, Ryan N. Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL): initial reliability and validity data. J Am Acad Child Adolesc Psychiatry. 1997 Jul;36(7):980-8. doi: 10.1097/00004583-199707000-00021.

    PMID: 9204677BACKGROUND
  • Polanczyk G, de Lima MS, Horta BL, Biederman J, Rohde LA. The worldwide prevalence of ADHD: a systematic review and metaregression analysis. Am J Psychiatry. 2007 Jun;164(6):942-8. doi: 10.1176/ajp.2007.164.6.942.

    PMID: 17541055BACKGROUND
  • Vysniauske R, Verburgh L, Oosterlaan J, Molendijk ML. The Effects of Physical Exercise on Functional Outcomes in the Treatment of ADHD: A Meta-Analysis. J Atten Disord. 2020 Mar;24(5):644-654. doi: 10.1177/1087054715627489. Epub 2016 Feb 9.

    PMID: 26861158BACKGROUND
  • Buker N, Karagoz E, Sengul YS, Guney SA, Ozbek A. Neurocognitive training enhances the outcomes of children with attention deficit hyperactivity disorder: A preliminary study. Child Care Health Dev. 2024 May;50(3):e13268. doi: 10.1111/cch.13268.

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Aylin Ozbek, MD

    Dokuz Eylul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The investigator who performed the outcome measures were blind to the groups, and did not know if the participant was actually a healthy control, or a patient with ADHD.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

January 11, 2021

First Posted

January 13, 2021

Study Start

January 8, 2018

Primary Completion

January 8, 2020

Study Completion

January 8, 2020

Last Updated

January 20, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations