Neurocognitive Exercise Program for Children With Attention Deficit and Hyperactivity Disorder
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Neurocognitive Exercise Program
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder
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
Sites / Locations
- Dokuz Eylul University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Neurocognitive Exercise Program Group
Arm Description
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).
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
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.
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)].
Full Information
NCT ID
NCT04707040
First Posted
January 11, 2021
Last Updated
January 16, 2021
Sponsor
Dokuz Eylul University
1. Study Identification
Unique Protocol Identification Number
NCT04707040
Brief Title
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
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 8, 2018 (Actual)
Primary Completion Date
January 8, 2020 (Actual)
Study Completion Date
January 8, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
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.
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neurocognitive Exercise Program Group
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Neurocognitive Exercise Program
Intervention Description
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
Primary Outcome Measure Information:
Title
Stroop color-word test
Description
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.
Time Frame
12 months
Title
Conners parent rating scale-revised short (CPRS-RS)
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Wisconsin Card Sorting Test (WCST)
Description
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.
Time Frame
12 months
Title
Y-Balance test
Description
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)].
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aylin Ozbek, MD
Organizational Affiliation
Dokuz Eylul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dokuz Eylul University
City
İzmir
State/Province
Narlıdere
ZIP/Postal Code
35320
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
4015311
Citation
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.
Results Reference
background
PubMed Identifier
31212854
Citation
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.
Results Reference
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PubMed Identifier
17554003
Citation
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.
Results Reference
background
PubMed Identifier
28356743
Citation
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.
Results Reference
background
PubMed Identifier
14590620
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.
Results Reference
background
PubMed Identifier
9204677
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.
Results Reference
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PubMed Identifier
17541055
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.
Results Reference
background
PubMed Identifier
26861158
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.
Results Reference
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Neurocognitive Exercise Program for Children With Attention Deficit and Hyperactivity Disorder
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