Attention Deficit Hyperactivity DisorderNCT04707040
Neurocognitive Exercise Program for Children With Attention Deficit and Hyperactivity Disorder
A study testing Neurocognitive Exercise Program in people with Attention Deficit Hyperactivity Disorder, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Neurocognitive Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jan 2018to 8 Jan 2020
- 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 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dokuz Eylul University
Izmir, Narlıdere, 35320
About this study
Official title: Investigation of the Effects of Neurocognitive Exercise Program in Symptom Severity and Executive Functions in Children With Attention Deficit and Hyperactivity Disorder
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.
Read the 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Neurocognitive Exercise Program
- 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.
Neurocognitive Exercise ProgramOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Neurocognitive Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 12 months
Secondary outcomes (2)
Wisconsin Card Sorting Test (WCST)
The WCST is a test used for executive function assessment, which includes measurements related to strategic planning, updating, shift cognitive set, modulating impulsive responding, and perseveration (Greve et al., 2005). The computer version of the test was used in this study (Heaton, 2008). The WCST included four stimulus cards and 128 response cards. Respondents were required to sort response cards based on one of three characteristics (i.e., color, form, and number) of the four stimulus cards. The computer gives 'correct' or 'wrong' feedback after each response. The ranking category changes when the participant selects the appropriate card for 10 cards. The test is completed after the participant has completed 6 categories or at the end of 128 response cards.
Measured: 12 months
Y-Balance test
Y-Balance Test (YBT) was used to evaluate the dynamic balance of children. YBT was performed in three directions (anterior, posteromedial, and posterolateral). The test protocol was applied based on the learning effect (Hertel et al., 2000). After measuring the leg length (anterior superior iliac spine to the medial malleolus) of the children, the average of three measurements taken after 6 attempts in both directions with both feet was taken as the test score. [YBT normalized value: (Average of 3 reach distances) / limb length x 100; YBT composite score: (Anterior + Posteromedial + Posterolateral) / (3 x Limb Length) x100)].
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start8 Jan 2018
- Primary completion8 Jan 2020
- Study completion8 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi Karagoz Tanigor M.D., Dokuz Eylul University
- Investigators
- Aylin Ozbek, MD, Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707040
- Sponsor's protocol ID
- ADHD-NEP
- Status last verified
- Jan 2021
- First submitted
- 11 Jan 2021
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 4015311Christiansen 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.
PubMed 31212854Diedrichsen 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.
PubMed 17554003Goetz 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.
PubMed 28356743Greve 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.
PubMed 14590620Kaufman 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.
PubMed 9204677Polanczyk 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.
PubMed 17541055Vysniauske 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.
PubMed 26861158Buker 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.
PubMed 38767513
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Neurocognitive Exercise Program in Symptom Severity and Executive Functions in Children With Attention Deficit and Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT04707040
- Acronym / sponsor ID
- ADHD-NEP
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 8 Jan 2020 (actual)
- Study completion
- 8 Jan 2020 (actual)
- First posted
- 13 Jan 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurocognitive Exercise Program Group | Experimental | Other: Neurocognitive Exercise ProgramThe 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). |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (6 listed)
- Presence of anxiety,
- Presence of depression,
- Presence of learning disability,
- Presence of intellectual disability,
- Presence of visual impairment,
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 |
|---|---|---|
| Neurocognitive Exercise ProgramNeurocognitive 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 | Other | Neurocognitive Exercise Program Group |
Primary outcome
Stroop color-word test
Time frame: 12 months
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.
Conners parent rating scale-revised short (CPRS-RS)
Time frame: 12 months
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
2 secondary outcomes
Wisconsin Card Sorting Test (WCST)
Time frame: 12 months
Y-Balance test
Time frame: 12 months
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 20 Jan 2021.
- Background: PubMed 4015311Chambers 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.
- Background: PubMed 31212854Christiansen 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.
- Background: PubMed 17554003Diedrichsen 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.
- Background: PubMed 28356743Goetz 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.
- Background: PubMed 14590620Greve 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.
- Background: PubMed 9204677Kaufman 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.
- Background: PubMed 17541055Polanczyk 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.
- Background: PubMed 26861158Vysniauske 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.
- Derived from this study: PubMed 38767513Buker 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.
- Individual participant dataSharing planned: No
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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.
Aylin Ozbek, MD principal investigator
Dokuz Eylul 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 Neurocognitive Exercise Program in people with Attention Deficit Hyperactivity Disorder, run by Dokuz Eylul 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 6 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 20 Jan 2021. 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?
Stroop color-word test (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04707040, which also lists 9 linked publications.
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 20 Jan 2021.