- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04279652
Exercise in Children Attention Deficit Hyperactivity Disorder
The Effects of Combined Exercise Program in Children Attention Deficit Hyperactivity Disorder
Study Overview
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
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey, 06100
- Recruiting
- Hacettepe University
-
Contact:
- Arzu Demircioğlu
- Phone Number: 0905377746515
- Email: arzu.demircioglu90@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Supervised exercise group
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.
|
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.
|
Active Comparator: Home exercise group
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.
|
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.
|
No Intervention: Control group
Children will not be included in any treatment program.
The assessments will be done again 8 weeks later.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motor Proficiency
Time Frame: 45 minutes
|
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
|
45 minutes
|
Cognitive assessment
Time Frame: 90 minutes
|
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
|
Physical Fitness
Time Frame: 15 minutes
|
Munich Fitness Test
|
15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Behavior Disorders
Time Frame: 5 minutes
|
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
|
Behaviour characteristics
Time Frame: 5 minutes
|
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
|
Hand dominance
Time Frame: 5 minutes
|
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
|
gait endurance
Time Frame: 4 minutes
|
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
|
muscle strength
Time Frame: 10 minutes
|
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
|
10 meter walking test
Time Frame: 2 minutes
|
Walking speed
|
2 minutes
|
Open ended questions
Time Frame: 15 minutes
|
these questions for social cooperation and behaviour
|
15 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KA-19032
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Exercise
-
Faculdade de Motricidade HumanaCompletedGreen Exercise | Indoor ExercisePortugal
-
Hasan Kalyoncu UniversityNot yet recruiting
-
University of HawaiiKlein Buendel, Inc.CompletedMomZing Exercise Videos Online | Standard Exercise DVDUnited States
-
Istanbul Medipol University HospitalCompletedPulmonary Rehabilitation | Exercise Capacity | Exercise TestTurkey
-
University Hospital MuensterGerman Federal Ministry of Education and ResearchUnknownAerobic Exercise | Anaerobic Exercise | Unchanged ConditionGermany
-
Paracelsus Medical UniversityDepartment of Psychiatry University of BonnRecruitingHealthy | Exercise | Physical Fitness | Exercise TestAustria
-
Nathaniel JenkinsCompletedExercise Training | Physical Exertion | Desire to ExerciseUnited States
-
University of GeorgiaRecruitingBiomarkers | Aerobic Exercise | Acute ExerciseUnited States
-
University of TaipeiCompletedAerobic Exercise | Massage | Anaerobic Exercise
-
University of Alberta, Physical EducationCompletedSedentary Behaviour | Adherence | Traditional Exercise | Lifestyle ExerciseCanada
Clinical Trials on Combined exercise
-
Hitit UniversityCompleted
-
Instituto de Cardiologia do Rio Grande do SulCompletedHypertension | Healthy
-
Charles University, Czech RepublicMinistry of Health, Czech Republic; EXCELES LX22NPO5104, CarDiaRecruiting
-
Ege UniversityRecruiting
-
Evangelismos HospitalCompletedHeart Failure | Diastolic DysfunctionGreece
-
Eastern Mediterranean UniversityUnknownThe Effect of Exercise Training on Balance and Functional Status in Individuals With Osteoarthritis'Osteo Arthritis Knee | BalanceCyprus
-
IRCCS San Raffaele RomaCompletedHypertension | Cardiac DiseaseItaly
-
Yuksek Ihtisas UniversityCompletedDementia | Frailty | Cognitive Function | Reaction Time | Aerobic Exercise | Balance ExerciseTurkey
-
Maria Gabriela Aké PalomoUniversidad Autónoma de YucatánCompletedDiabetes Mellitus, Type 2 | Neuropathic Pain | Neuropathy, DiabeticMexico
-
Heitor Moreno JuniorUnknown