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Effect of Aerobic Exercise on Cognition, Emotion and Motor Coordination in Children with ADHD

Status Approved

First Submitted Date

2013/07/29
Registered Date

2013/10/02
Last Updated Date

2013/10/02

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0000872
Unique Protocol ID	연정임130601
Public/Brief Title	Effect of Aerobic Exercise on Mental health and Physical function in Children with ADHD
Scientific Title	Effect of Aerobic Exercise on Cognition, Emotion and Motor Coordination in Children with ADHD
Acronym
MFDS Regulated Study	No
IND/IDE Protocol
Registered at Other Registry	No
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	연정임130601
Approval Date	2013-06-26
Institutional Review Board Name	SEVERANCE MENTAL HEALTH HOSPITAL, YONSEI UNIVERSITY COLLEGE of MEDICINE, INSTUTUTIONAL REVIEW BOARD
Institutional Review Board Address
Institutional Review Board Telephone
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Daeyoung Roh
Title	MD
Telephone
Affiliation	Severance Mental Health Hospital, Yonseity University
Address
Contact Person for Public Queries
Name	Daeyoung Roh
Title	MD
Telephone
Affiliation	Severance Mental Health Hospital, Yonseity University
Address
Contact Person for Updating Information
Name	Daeyoung Roh
Title	MD
Telephone
Affiliation	Severance Mental Health Hospital, Yonseity University
Address

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2013-08-07 Actual
Target Number of Participant	70
Primary Completion Date	2013-11-27 , Anticipated
Study Completion Date
Name of Study	Severance Mental Health Hospital, Yonseity University
Recruitment Status	Recruiting
Date of First Enrollment	2013-08-07 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Severance Mental Health Hospital, Yonseity University
Organization Type	Medical Institute
Project ID	연정임130601

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Severance Mental Health Hospital, Yonseity University
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	The inattention and hyperactivity-impulsivity that characterize children with attention-deficit hyperactivity disorder (ADHD) are associated with organisational problems, risk for achievement difficulties, and extensive negative criticism from parents and teachers. These children experience negative outcomes in personal, educational, and social domains that might impair their functional adaptation throughout their life The growing body of evidence supporting the beneficial effects of physical activity in the improvement of cognitive functions for different populations includes positive impacts on executive functions impaired in the ADHD. Nevertheless, the diversity of the variables assessed as well as methodological issues in previous studies including children with ADHD do not allow for consensus. Considering the clinical importance of an improvement in cognitive functions and behavior on the functional adaptation of children with ADHD, the objectives of this study is to assess the effects of a moderate- to high-intensity physical activity program lasting 12 weeks on fitness, cognitive functions, and behavior in children with ADHD. It was hypothesized that the program would result in improved fitness, ADHD-related behaviors, cognitive functions and motor coordinating ability.

Study Summary Information

Lay Summary

The inattention and hyperactivity-impulsivity that characterize children with attention-deficit hyperactivity disorder (ADHD) are associated with organisational problems, risk for achievement difficulties, and extensive negative criticism from parents and teachers. These children experience negative outcomes in personal, educational, and social domains that might impair their functional adaptation throughout their life
   The growing body of evidence supporting the beneficial effects of physical activity in the improvement of cognitive functions for different populations includes positive impacts on executive functions impaired in the ADHD. Nevertheless, the diversity of the variables assessed as well as methodological issues in previous studies including children with ADHD do not allow for consensus.
  Considering the clinical importance of an improvement in cognitive functions and behavior on the functional adaptation of children with ADHD, the objectives of this study is to assess the effects of a moderate- to high-intensity physical activity program lasting 12 weeks on fitness, cognitive functions, and behavior in children with ADHD. It was hypothesized that the program would result in improved fitness, ADHD-related behaviors, cognitive functions and motor coordinating ability.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Supportive Care
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Open
Allocation	Not Applicable
Intervention Type	Behavioral
Intervention Description	Experimental group: an hour of exercise with bike riding, once every week, for 3 months
Number of Arms	2
Arm 1	Arm Label ADHD Group
	Target Number of Participant 35
	Arm Type Experimental
	Arm Description An hour of exercise with bike riding, once every week, for 3 months. Exercise therapy will be delivered uniformly according to a strict protocol and supervised by a psychomotor therapist and monitored by nurses, social workers specialized in psychiatry. To prevent dropout of patients due to injury and exhaustion, exercise intensity will be increased gradually.
Arm 2	Arm Label Healthy Control Group
	Target Number of Participant 35
	Arm Type Experimental
	Arm Description An hour of exercise with bike riding, once every week, for 3 months. Exercise therapy will be delivered uniformly according to a strict protocol and supervised by a psychomotor therapist and monitored by nurses, social workers specialized in psychiatry. To prevent dropout of patients due to injury and exhaustion, exercise intensity will be increased gradually.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (F00-F99)Mental and behavioural disorders (F90.0)Disturbance of activity and attention
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 8Year~13Year
	Description 1) Participants previously received an ADHD diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders (4th ed.) 2) Healthy children with no psychiatric problems
Exclusion Criteria	1)Children with learning disorders, autism, Tourette’s syndrome, intellectual disabilities, epileptic disorders, or who took medication other than the usual ADHD stimulant treatment (methylphenidate) 2) Any evidence of significant cardiovascular, neuromuscular, endocrine, or other somatic disorders
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Comprehensive Attention Test
Timepoint	Baseline and follow-up measurements (after 4 months of intervention) +- 1 week
Primary Outcome(s) 2
Outcome	Child Behavior Check List
Timepoint	Baseline and follow-up measurements (after 4 months of intervention) +- 1 week
Primary Outcome(s) 3
Outcome	Parent Stress Index
Timepoint	Baseline and follow-up measurements (after 4 months of intervention) +- 1 week
Primary Outcome(s) 4
Outcome	Korean Youth Physical Activity Questionnaire
Timepoint	Baseline and follow-up measurements (after 4 months of intervention) +- 1 week
Secondary Outcome(s) 1
Outcome	Shuttle run
Timepoint	Baseline and follow-up measurements (after 4 months of intervention) +- 1 week
Secondary Outcome(s) 2
Outcome	Test of Gross Motor Development
Timepoint	Baseline and follow-up measurements (after 4 months of intervention) +- 1 week

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Not provided at time of Registration

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