- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05150223
The Effects of Functional Power Training in Children With Attention Deficit Hyperactivity Disorder
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
Study Overview
Status
Intervention / Treatment
Detailed Description
Attention Deficit Hyperactivity Disorder is a neurodevelopmental disorder characterized by inattention, impulsivity, and hyperactivity. These core symptoms cause poor gross and fine motor skills. Recent critical review results suggest that motor performance not only consists of motor response activation. It also includes mental representation of activity, attention, memory, makes decisions, and control over preponderant responses. These findings support that ADHD symptoms could affect motor performance negatively. DSM-V (The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) also specifies the relationship between ADHD symptoms and poor motor performance. DSM-V pointed out motor difficulties that occur in ADHD are caused by inattention and impulsivity rather than neurological origin. In the literature, Tseng et al. investigated ADHD symptom's negative effect on motor performance in 42 school-aged children with ADHD. Tseng et al.'s study was shown that inattention and impulsivity were determinative symptoms for motor difficulties. Because of the ADHD's symptoms' effect on the motor skill, children with ADHD have poor fine manual control, manual coordination, body coordination, strength, and agility when they are compared with health peers.
These motor difficulties affect the academic, social, and daily life of children with ADHD. They have many restrictions on participation of daily living activities, school, social and sport activities and have decreased quality of life scores. It is considered that these symptoms of ADHD related to catecholamine systems. Jeyanthi et al. suggest that exercises both directly and indirectly affects catecholamine systems. In the literature, there are many studies that was included different exercise interventions involving children with ADHD. Many of the studies were shown that exercise had positive effects on ADHD symptoms. However, there is not enough information about the type, duration, intensity, and frequency of appropriate exercises. Power exercises can be an appropriate approach given the previously reported problems in children with ADHD. This type of exercise shown positive effects on the other populations (CP). The aim of the study is to investigate the effect of power exercises on children with ADHD by comparing these effects with traditional strength training and their healthy peers.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Antalya, Turkey
- Akdeniz University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Traditional strength training group
traditional strength training (running, jumping forward over a barrier with one leg and two legs, heel-rise, push up and ball throw with load, bench press, and flexion-abduction-external rotation pattern with theraband)
|
traditional strength training (running, jumping forward over a barrier with one leg and two legs, heel-rise, push up and ball throw with load, bench press, and flexion-abduction-external rotation pattern with theraband).
Participation in the traditional strength training group will complete these exercises with a load and without time limitations and speed.
|
|
EXPERIMENTAL: Power Training group
progressive functional strength training protocol (running, jumping forward over a barrier with one leg and two legs, heel-rise, push up and ball throw with load, bench press, and flexion-abduction-external rotation pattern with theraband)
|
progressive functional strength training protocol (running, jumping forward over a barrier with one leg and two legs, heel-rise, push up and ball throw with load, bench press, and flexion-abduction-external rotation pattern with theraband)
|
|
NO_INTERVENTION: Control group
no intervention Typically developing children
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Conners' Teacher Rating Scale (CTRS)
Time Frame: change from baseline to end of the 8 weeks
|
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
|
|
Bruininks-Oseretsky Test of Motor Proficiency-2 (BOT-2) to measure motor proficiency.
Time Frame: change from baseline to end of the 8 weeks
|
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
|
|
Evaluation of muscle power of lower extremity
Time Frame: change from baseline to end of the 8 weeks
|
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
|
|
Evaluation of muscle power of upper extremity
Time Frame: change from baseline to end of the 8 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The 30 seconds Repetition Maximum test
Time Frame: change from baseline to end of the 8 weeks
|
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 five final scores were obtained.
|
change from baseline to end of the 8 weeks
|
|
walking speed
Time Frame: change from baseline to end of the 8 weeks
|
1 Minute Walk Test (1 MWT) will be used to assess walking speed.
|
change from baseline to end of the 8 weeks
|
|
Evaluation of participation
Time Frame: change from baseline to end of the 8 weeks
|
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
|
|
Evaluation of quality of life
Time Frame: change from baseline to end of the 8 weeks
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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. doi: 10.1017/s0012162204000623.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-088
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 Attention Deficit Hyperactivity Disorder
-
King's College LondonActive, not recruitingAttention-Deficit Hyperactivity Disorder | Attention-Deficit Hyperactivity Disorder SymptomsUnited Kingdom
-
Cingulate TherapeuticsSuspendedPhase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301ADHD | Attention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | ADHD - Combined Type | Attention Deficit Hyperactivity Disorder Combined | Attention Deficit Hyper Activity | Attention-deficit HyperactivityUnited States
-
Ornit CohenUnknownAttention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | Attention Deficit Disorder | Attention Deficit Disorders With Hyperactivity | Attention Deficit Hyperactivity DisordersIsrael
-
Cingulate TherapeuticsPremier Research Group plcCompletedADHD | Attention Deficit Hyperactivity Disorder | ADHD - Combined Type | Attention Deficit Hyperactivity Disorder Combined | Attention Deficit Hyper Activity | Attention-deficit HyperactivityUnited States
-
Qbtech ABEnrolling by invitationAttention Deficit Disorder With Hyperactivity (ADHD) | Attention Deficit Disorder (ADD)United States
-
University of Texas at AustinRecruitingAttention Deficit Hyperactivity DisorderUnited States
-
Rutgers, The State University of New JerseyNational Institute of Mental Health (NIMH); Louisiana State University Health...Recruiting
-
Tongren Hongxin Kangxin Traditional Chinese Medicine...CompletedAttention Deficit Hyperactivity DisorderChina
-
Aytu BioPharma, Inc.Premier Research Group plcWithdrawnAttention Deficit Hyperactivity DisorderUnited States
-
Universidade do Sul de Santa CatarinaAssociação Brasileira de Cannabis MedicinalRecruitingAttention-Deficit/Hyperactivity Disorder (ADHD)Brazil
Clinical Trials on traditional strength training
-
Norwegian University of Science and TechnologyCompleted
-
Medical University of South CarolinaCompleted
-
Ibadat International University, IslamabadRecruitingAthletic Performance | Neuromuscular TrainingPakistan
-
Hacettepe UniversityCompletedSpastic Hemiplegic Cerebral PalsyTurkey
-
Louisiana State University Health Sciences Center...Eunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedCentral Nervous System Diseases | Cerebral Palsy | Brain Damage, ChronicUnited States
-
Engin Güneş AtabaşCompletedAthletic Performance | Muscle Strength | Resistance TrainingTurkey (Türkiye)
-
Hacettepe UniversityCompletedSpastic Hemiplegic Cerebral PalsyTurkey
-
European University Miguel de CervantesHospital Clínico Universitario de ValladolidRecruitingHigh Intensity Interval Training (Cycling) | High Intensity Interval Training (Running) | High Intensity Functional Training | Moderate Intensity Functional Training | High Intensity Traditional Strength Training | Moderate Intensity Traditional Strength TrainingSpain
-
University of UtahCompletedFeasibility StudiesUnited States
-
University of AarhusUnknownOsteoarthritis, KneeDenmark