Clinical trial NCT04707040: Neurocognitive Exercise Program for Children With Attention Deficit and Hyperactivity Disorder
Official title: Investigation of the Effects of Neurocognitive Exercise Program in Symptom Severity and Executive Functions in Children With Attention Deficit and Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 14
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

Material and Methods: Twenty-nine boys (14 ADHD, 15 Healthy Controls) between 7 and 13 years of age will be recruited in the study and The Conners parent rating scale-revised short (CPRS-RS), Stroop Test, Wisconsin test and Y-Balance test will be performed . All tests and measurements will be performed for ADHD group before NEP, after NEP, 6 months and 12 months. The control group will be evaluated only once.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Stroop color-word test
timeFrame: 12 months
measure: Conners parent rating scale-revised short (CPRS-RS)
timeFrame: 12 months
Secondary outcomes:
measure: Wisconsin Card Sorting Test (WCST)
timeFrame: 12 months
measure: Y-Balance test
timeFrame: 12 months
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylul University
state: Narlıdere
Study officials:
affiliation: Dokuz Eylul University
name: Aylin Ozbek, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.