Attention Deficit Hyperactivity DisorderNCT05150223
The Effects of Functional Power Training in Children With Attention Deficit Hyperactivity Disorder
A study testing traditional strength training and Power training in people with Attention Deficit Hyperactivity Disorder and Child Mental Disorder, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Child Mental Disorder
- What is being tested?
- traditional strength training and Power training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 15 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- • 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
- Healthy children aged 6-12 years old
- Children without a psychiatric and neurological diagnosis
Who cannot join
- • 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.
- Children got medical treatment for a neuropsychiatric disorder
- Children whose parents or themselves refused to participate
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- traditional strength training, Power training
- Keywords
- attention deficit, hyperactivity disorder, power, strength, training
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional strength trainingOther
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.
Power trainingOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Traditional strength training group | Active comparator | 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) Receives: Other: traditional strength training |
| Power Training group | Experimental | 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) Receives: Other: Power training |
| Control group | No intervention | no intervention Typically developing children |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change from baseline to end of the 8 weeks
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.
Measured: change from baseline to end of the 8 weeks
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.
Measured: change from baseline to end of the 8 weeks
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.
Measured: change from baseline to end of the 8 weeks
Secondary outcomes (4)
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 five final scores were obtained.
Measured: change from baseline to end of the 8 weeks
walking speed
1 Minute Walk Test (1 MWT) will be used to assess walking speed.
Measured: change from baseline to end of the 8 weeks
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).
Measured: change from baseline to end of the 8 weeks
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.
Measured: change from baseline to end of the 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start1 Dec 2021
- Primary completion15 Apr 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Collaborators
- Antalya Training and Research Hospital
- Responsible party
- Principal investigator, Ozgun Kaya Kara, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150223
- Sponsor's protocol ID
- 2021-088
- Status last verified
- Jun 2022
- First submitted
- 9 Nov 2021
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 15174529S 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.
PubMed 30264226Cho 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.
PubMed 25110492Kaya 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.
PubMed 31220015Moreau 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.
PubMed 23292847Messler 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.
PubMed 27013028Goulardins 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.
PubMed 28361657
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05150223
- Acronym / sponsor ID
- 2021-088
- Keywords
- attention deficit, hyperactivity disorder, power, strength, training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Collaborators
- Antalya Training and Research Hospital
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 9 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traditional strength training group | Active comparator | Other: traditional strength trainingtraditional 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) |
| Power Training group | Experimental | Other: Power trainingprogressive 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) |
| Control group | No intervention | –no intervention Typically developing children |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- • age between 6 years and 12 years;
- Healthy children aged 6-12 years old
- Children without a psychiatric and neurological diagnosis
Key exclusion criteria (4 listed)
- • Children have any other psychiatric diagnosis like autism spectrum disorder, psychotic symptoms, depression, etc.
- Children got medical treatment for a neuropsychiatric disorder
- Children whose parents or themselves refused to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| traditional strength trainingtraditional 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. | Other | Traditional strength training group |
| Power trainingprogressive 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) | Other | Power Training group |
Primary outcome
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.
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.
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.
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.
4 secondary outcomes
The 30 seconds Repetition Maximum test
Time frame: change from baseline to end of the 8 weeks
walking speed
Time frame: change from baseline to end of the 8 weeks
Evaluation of participation
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Background: PubMed 15174529Tseng 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.
- Background: PubMed 30264226S 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.
- Background: PubMed 25110492Cho 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.
- Background: PubMed 31220015Kaya 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.
- Background: PubMed 23292847Moreau 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.
- Background: PubMed 27013028Messler 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.
- Background: PubMed 28361657Goulardins 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.
- National Strength and Conditioning AssociationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing traditional strength training and Power training in people with Attention Deficit Hyperactivity Disorder and Child Mental Disorder, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conners' Teacher Rating Scale (CTRS) (time frame: change from baseline to end of the 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05150223, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.