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Exercise in Children Attention Deficit Hyperactivity Disorder

Primary Purpose

ADHD, Exercise

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Combined exercise
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD focused on measuring ADHD, Exercise, motor proficiency

Eligibility Criteria

7 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Having been diagnosed with ADHD according to DSM-V (The Diagnostic and Statistical Manual of Mental Disorders-V) diagnostic criteria,
  • Being between the ages of 7-12,
  • Right hand being dominant according to Edinburgh Hand Preference Questionnaire,
  • After the purpose of the study and the procedures to be explained, both the child and his family agree to participate in the study,
  • An appropriate drug treatment program has been organized by the psychiatrist,
  • The absence of a contraindicated condition to exercise in physical and medical examination.

Exclusion Criteria:

  • A major psychiatric and / or neurodevelopmental problem accompanying,
  • A history of head injury or chronic neurological disease,
  • Having additional medical diseases that require medication,
  • Any changes made in the psychiatric drug treatment by the attending physician for the last 1 month,
  • Have participated in a regular exercise program or sporting activity for the past 6 months.

Sites / Locations

  • Hacettepe UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Supervised exercise group

Home exercise group

Control group

Arm Description

The treatment program was determined as 3 sessions per week for 8 weeks and 60 minutes per session. The treatment program consists of 5 min warm-up exercises, 20 min aerobic exercise, 20 min balance-coordination exercises, 10 min strengthening exercises and 5 min cooling exercises.

The exercise program, which is prepared for the individual, will be applied to the home exercise group with 60 minutes of 3 times a week.

Children will not be included in any treatment program. The assessments will be done again 8 weeks later.

Outcomes

Primary Outcome Measures

Motor Proficiency
Motor proficiency will be evaluated The Bruininks-Oseretsky Test of Motor Proficiency Second Edition (BOT™-2). t contains subtests and challenging game-like tasks and is very easy to administer. the score of this test ranges from 0 to 322. Higher score indicates better motor proficiency
Cognitive assessment
Dynamic Occupational Therapy Cognitive Assessment (DOTCA-Ch) battery for children allows to evaluate cognitive skills in 5 main topics: orientation, spatial perception, praxis, visual-motor organization and thinking processes.
Physical Fitness
Munich Fitness Test

Secondary Outcome Measures

Behavior Disorders
Conners Parent Rating Scale consists of 27 items in total. In this scale, questions are answered on a 4-point Likert scale. "Never", "rarely", "often" and "always" options are; It is scored as "0", "1", "2" and "3". High scores from the scale show the intensity of symptoms specific to destructive disorders
Behaviour characteristics
Strength and Difficulties Questionnaire - (SDQ) "contains 25 questions, some of which question positive and some negative behavior characteristics. Each sub-title can be evaluated within itself and a separate score can be obtained for each, as well as the sum of the first four titles and the" Total Strength Score ".
Hand dominance
Edinburgh Hand Preference Questionnaire was developed to determine the hand preferences of the persons.The sum of the right and left hand scores gives "Cumulative Total (TC)" and subtracting the left hand score from the right hand score gives "Difference score (F)". The result score is obtained by dividing the difference score by the cumulative total score and multiplying it by the face. Result score; It can be interpreted that if the person is less than 40, the person is left dominant, and between -40 and 40, each bilateral dominant, and if greater than 40, the person is right dominant.
gait endurance
2-minute walking test will be used to determine walking endurance. In this test, a distance of 50 feet (15.2 meters) in length is determined first. The evaluator marks each 10 foot long distance with markers, leaving a cone at the beginning and end of the total distance.
muscle strength
Isometric muscle strength will be evaluated by hand dynamometer. Care is taken to repeat 3 times at short intervals during measurements. The highest value will be used for analysis. 4 muscle groups, including shoulder abductors, grip strength, hip flexors and ankle dorsi flexors, will be evaluated bilaterally.
10 meter walking test
Walking speed
Open ended questions
these questions for social cooperation and behaviour

Full Information

First Posted
February 19, 2020
Last Updated
July 15, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04279652
Brief Title
Exercise in Children Attention Deficit Hyperactivity Disorder
Official Title
The Effects of Combined Exercise Program in Children Attention Deficit Hyperactivity Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2020 (Actual)
Primary Completion Date
October 28, 2023 (Anticipated)
Study Completion Date
December 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe 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
Attention Deficit Hyperactivity Disorder (ADHD) is a heterogeneous neurodevelopmental disorder characterized by carelessness, hyperactivity and impulsivity, in which genetic, social and physical factors play an important role. Few studies have revealed the physical activity levels and importance of children with ADHD, but there is no consensus on the components of the physical activity program such as intensity, frequency, and severity. The aim of the present study is to investigate the effect of combined exercise training on motor proficiency, physical fitness and cognitive status in children with ADHD.
Detailed Description
The aim of present study is to investigate the effect of combined exercise training on motor proficiency, physical fitness and cognitive status in children with ADHD. Children will be randomly divided into 3 groups, for 8 weeks the first group will undergo a combined exercise training under the supervision of a physiotherapist, while the second group will receive a home exercise program. children included in the third group will form the control group. The following assessments will be applied at the beginning and end of treatment. Revised Conners Parent Rating Scale Short Turkish Form Powers and Challenges Survey Edinburgh Hand Preference Survey Two-minute walking test Ten meter walking test Munich Fitness Test Bruininks-Oseretsky Motor Proficiency Test-2 Muscle strength evaluation Dynamic Occupational Therapy Cognitive Assessment Open-ended questions

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD, Exercise
Keywords
ADHD, Exercise, motor proficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supervised exercise group
Arm Type
Experimental
Arm Description
The treatment program was determined as 3 sessions per week for 8 weeks and 60 minutes per session. The treatment program consists of 5 min warm-up exercises, 20 min aerobic exercise, 20 min balance-coordination exercises, 10 min strengthening exercises and 5 min cooling exercises.
Arm Title
Home exercise group
Arm Type
Active Comparator
Arm Description
The exercise program, which is prepared for the individual, will be applied to the home exercise group with 60 minutes of 3 times a week.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Children will not be included in any treatment program. The assessments will be done again 8 weeks later.
Intervention Type
Other
Intervention Name(s)
Combined exercise
Intervention Description
Combined exercise program consists of 5 min warm-up exercises, 20 min aerobic exercise, 20 min balance-coordination exercises, 10 min strengthening exercises and 5 min cooling exercises.
Primary Outcome Measure Information:
Title
Motor Proficiency
Description
Motor proficiency will be evaluated The Bruininks-Oseretsky Test of Motor Proficiency Second Edition (BOT™-2). t contains subtests and challenging game-like tasks and is very easy to administer. the score of this test ranges from 0 to 322. Higher score indicates better motor proficiency
Time Frame
45 minutes
Title
Cognitive assessment
Description
Dynamic Occupational Therapy Cognitive Assessment (DOTCA-Ch) battery for children allows to evaluate cognitive skills in 5 main topics: orientation, spatial perception, praxis, visual-motor organization and thinking processes.
Time Frame
90 minutes
Title
Physical Fitness
Description
Munich Fitness Test
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Behavior Disorders
Description
Conners Parent Rating Scale consists of 27 items in total. In this scale, questions are answered on a 4-point Likert scale. "Never", "rarely", "often" and "always" options are; It is scored as "0", "1", "2" and "3". High scores from the scale show the intensity of symptoms specific to destructive disorders
Time Frame
5 minutes
Title
Behaviour characteristics
Description
Strength and Difficulties Questionnaire - (SDQ) "contains 25 questions, some of which question positive and some negative behavior characteristics. Each sub-title can be evaluated within itself and a separate score can be obtained for each, as well as the sum of the first four titles and the" Total Strength Score ".
Time Frame
5 minutes
Title
Hand dominance
Description
Edinburgh Hand Preference Questionnaire was developed to determine the hand preferences of the persons.The sum of the right and left hand scores gives "Cumulative Total (TC)" and subtracting the left hand score from the right hand score gives "Difference score (F)". The result score is obtained by dividing the difference score by the cumulative total score and multiplying it by the face. Result score; It can be interpreted that if the person is less than 40, the person is left dominant, and between -40 and 40, each bilateral dominant, and if greater than 40, the person is right dominant.
Time Frame
5 minutes
Title
gait endurance
Description
2-minute walking test will be used to determine walking endurance. In this test, a distance of 50 feet (15.2 meters) in length is determined first. The evaluator marks each 10 foot long distance with markers, leaving a cone at the beginning and end of the total distance.
Time Frame
4 minutes
Title
muscle strength
Description
Isometric muscle strength will be evaluated by hand dynamometer. Care is taken to repeat 3 times at short intervals during measurements. The highest value will be used for analysis. 4 muscle groups, including shoulder abductors, grip strength, hip flexors and ankle dorsi flexors, will be evaluated bilaterally.
Time Frame
10 minutes
Title
10 meter walking test
Description
Walking speed
Time Frame
2 minutes
Title
Open ended questions
Description
these questions for social cooperation and behaviour
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Having been diagnosed with ADHD according to DSM-V (The Diagnostic and Statistical Manual of Mental Disorders-V) diagnostic criteria, Being between the ages of 7-12, Right hand being dominant according to Edinburgh Hand Preference Questionnaire, After the purpose of the study and the procedures to be explained, both the child and his family agree to participate in the study, An appropriate drug treatment program has been organized by the psychiatrist, The absence of a contraindicated condition to exercise in physical and medical examination. Exclusion Criteria: A major psychiatric and / or neurodevelopmental problem accompanying, A history of head injury or chronic neurological disease, Having additional medical diseases that require medication, Any changes made in the psychiatric drug treatment by the attending physician for the last 1 month, Have participated in a regular exercise program or sporting activity for the past 6 months.
Facility Information:
Facility Name
Hacettepe University
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arzu Demircioğlu
Phone
0905377746515
Email
arzu.demircioglu90@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Exercise in Children Attention Deficit Hyperactivity Disorder

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