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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04279652
Other study ID # KA-19032
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 28, 2020
Est. completion date December 10, 2023

Study information

Verified date July 2023
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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. 1. Revised Conners Parent Rating Scale Short Turkish Form 2. Powers and Challenges Survey 3. Edinburgh Hand Preference Survey 4. Two-minute walking test 5. Ten meter walking test 6. Munich Fitness Test 7. Bruininks-Oseretsky Motor Proficiency Test-2 8. Muscle strength evaluation 9. Dynamic Occupational Therapy Cognitive Assessment 10. Open-ended questions


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 10, 2023
Est. primary completion date October 28, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 12 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms

  • ADHD
  • Attention Deficit Disorder with Hyperactivity
  • Exercise

Intervention

Other:
Combined exercise
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.

Locations

Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Motor Proficiency Motor proficiency will be evaluated The Bruininks-Oseretsky Test of Motor Proficiency Second Edition (BOTâ„¢-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 45 minutes
Primary 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. 90 minutes
Primary Physical Fitness Munich Fitness Test 15 minutes
Secondary 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 5 minutes
Secondary 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 ". 5 minutes
Secondary 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. 5 minutes
Secondary 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. 4 minutes
Secondary 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 minutes
Secondary 10 meter walking test Walking speed 2 minutes
Secondary Open ended questions these questions for social cooperation and behaviour 15 minutes
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