Attention Deficit Hyperactivity Disorder Clinical Trial
Official title:
The Effects of Functional Power Training on Attention, Gross and Fine Motor Skills, Participation and Quality of Life in Children With Attention Deficit Hyperactivity Disorder
NCT number | NCT05150223 |
Other study ID # | 2021-088 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 1, 2021 |
Est. completion date | June 15, 2022 |
Verified date | June 2022 |
Source | Akdeniz University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is aimed to investigate the effectiveness of functional power training on attention, gross and fine motor skill, participation and quality of life in children with attention deficit hyperactivity disorder (ADHD) by comparing traditional strength training and their healthy peers. In the literature, there are limited studies that investigate the effect of power exercise in children with ADHD. But there is no randomized controlled trial include power exercises which is designed to the National Strength and Conditioning Association (NSCA) criteria and investigate the effects on attention, gross and fine motor skill, participation and quality of life in children with ADHD. This study hypothesizes that power exercises could improve attention, gross and fine motor skill, participation, and quality of life better than traditional strength training in children with ADHD.
Status | Completed |
Enrollment | 61 |
Est. completion date | June 15, 2022 |
Est. primary completion date | April 15, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 12 Years |
Eligibility | Inclusion Criteria: - • age between 6 years and 12 years; - Diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) by a child and adolescent health psychiatrist, regardless of subtype, according to DSM-V criteria - Have cognitive ability to follow instructions for assessment measures and exercise intervention Exclusion Criteria: - • Children have any other psychiatric diagnosis like autism spectrum disorder, psychotic symptoms, depression, etc. - Children have any neurological or orthopedic disorders like head injury, cerebral palsy, epileptic seizure, visual and speech disorder. Inclusion Criteria for Healthy Children: - Healthy children aged 6-12 years old - Children without a psychiatric and neurological diagnosis Exclusion Criteria for Healthy Children: - Children got medical treatment for a neuropsychiatric disorder - Children whose parents or themselves refused to participate |
Country | Name | City | State |
---|---|---|---|
Turkey | Akdeniz University | Antalya |
Lead Sponsor | Collaborator |
---|---|
Akdeniz University | Antalya Training and Research Hospital |
Turkey,
Cho H, Ji S, Chung S, Kim M, Joung YS. Motor function in school-aged children with attention-deficit/hyperactivity disorder in Korea. Psychiatry Investig. 2014 Jul;11(3):223-7. doi: 10.4306/pi.2014.11.3.223. Epub 2014 Jul 21. — View Citation
Goulardins JB, Marques JC, De Oliveira JA. Attention Deficit Hyperactivity Disorder and Motor Impairment. Percept Mot Skills. 2017 Apr;124(2):425-440. doi: 10.1177/0031512517690607. Epub 2017 Jan 31. Review. — View Citation
Kaya Kara O, Livanelioglu A, Yardimci BN, Soylu AR. The Effects of Functional Progressive Strength and Power Training in Children With Unilateral Cerebral Palsy. Pediatr Phys Ther. 2019 Jul;31(3):286-295. doi: 10.1097/PEP.0000000000000628. — View Citation
Meßler CF, Holmberg HC, Sperlich B. Multimodal Therapy Involving High-Intensity Interval Training Improves the Physical Fitness, Motor Skills, Social Behavior, and Quality of Life of Boys With ADHD: A Randomized Controlled Study. J Atten Disord. 2018 Jun;22(8):806-812. doi: 10.1177/1087054716636936. Epub 2016 Mar 24. — View Citation
Moreau NG, Holthaus K, Marlow N. Differential adaptations of muscle architecture to high-velocity versus traditional strength training in cerebral palsy. Neurorehabil Neural Repair. 2013 May;27(4):325-34. doi: 10.1177/1545968312469834. Epub 2013 Jan 4. — View Citation
S J, Arumugam N, Parasher RK. Effect of physical exercises on attention, motor skill and physical fitness in children with attention deficit hyperactivity disorder: a systematic review. Atten Defic Hyperact Disord. 2019 Jun;11(2):125-137. doi: 10.1007/s12402-018-0270-0. Epub 2018 Sep 27. — View Citation
Tseng MH, Henderson A, Chow SM, Yao G. Relationship between motor proficiency, attention, impulse, and activity in children with ADHD. Dev Med Child Neurol. 2004 Jun;46(6):381-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Conners' Teacher Rating Scale (CTRS) | CTRS is a reliable and valid 59-item teacher self-report form designed to identify children with ADHD and associated behavioral difficulties. Each item can be scored from 0 to 3; where 0 represents an item is not present and 3 represents an always or definitely present symptom. | change from baseline to end of the 8 weeks | |
Primary | Bruininks-Oseretsky Test of Motor Proficiency-2 (BOT-2) to measure motor proficiency. | Bruininks-Oseretsky Test of Motor Proficiency-2 (BOT-2) is norm referenced and designed to measure gross and fine motor skills in youth 4 to 21 years of age. Standard scores 40 are considered below average, whereas those >40 range from average to above average. | change from baseline to end of the 8 weeks | |
Primary | Evaluation of muscle power of lower extremity | Muscle Power Sprint Test (MPST) will be used to assess lower extremity muscle power.Peak power and Mean Power (watts) were also calculated and used as markers of anaerobic power in the MPST. Power output for each sprint was calculated using body mass and running times, where power = (body mass Å~ distance2)/time. Peak power was defined as the highest calculated power, while Mean Power was defined as average power over the 6 runs. | change from baseline to end of the 8 weeks | |
Primary | Evaluation of muscle power of upper extremity | Throw Basketball Test will be used to assess upper extremity muscle power. The distance from the starting line to where the ball landed was recorded in centimetres. | change from baseline to end of the 8 weeks | |
Secondary | The 30 seconds Repetition Maximum test | The 30 seconds Repetition Maximum test was used to assess functional muscle strength of the lower extremities. The three closed kinetic chain exercises of lateral step-up test, Sit To Stand and attain stand through half knee were used. The children were instructed to perform as many repetitions as possible in 30 seconds for each of the exercises. Lateral step-up and attain stand through half knee were evaluated bilaterally. The repetition maximum for each side was used to calculate total scores for the left and right side and thus ?ve ?nal scores were obtained. | change from baseline to end of the 8 weeks | |
Secondary | walking speed | 1 Minute Walk Test (1 MWT) will be used to assess walking speed. | change from baseline to end of the 8 weeks | |
Secondary | Evaluation of participation | Participation and Environment Measurement Child & Youth (PEM-CY) is a parent-report questionnaire to assess participation and environment factors in the home, at school and within community Settings. The participation sections included 10 activities in the home setting, five activities in the school setting and 10 in the community setting. For each activity, parents are asked to determine the participation frequency (how frequently has the child participated with eight options: daily to never), participation involvement (how involved the child is while participating the activity rated on a five-point scale: very involved to minimally involved) and whether change is desired (do the parents want to see change in the child's participation in this type of activity: no or yes, with 5 different types of change). | change from baseline to end of the 8 weeks | |
Secondary | Evaluation of quality of life | The Pediatric Quality of Life Inventory (PEDS-QL) is a generic health related quality of life measure consisting of 4 core scales, physical function (8 items), emotional function (5 items), social function (5 items) and school function (5 items) that is intended for use in healthy and patient populations. Respondents are asked to recall the last month and indicate how frequently - from never to almost always - they have experienced specific phenomena. Item responses (0-100) are averaged to form total and core scores; higher scores indicate higher functioning. | change from baseline to end of the 8 weeks |
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