NCT04279652

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2022

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

2.8 years

First QC Date

February 19, 2020

Last Update Submit

December 22, 2025

Conditions

ADHDExercise

Keywords

ADHDExercisemotor proficiency

Outcome Measures

Primary Outcomes (3)

  • Motor Proficiency

    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

    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

    Munich Fitness Test

    15 minutes

Secondary Outcomes (7)

  • Behavior Disorders

    5 minutes

  • Behaviour characteristics

    5 minutes

  • Hand dominance

    5 minutes

  • gait endurance

    4 minutes

  • muscle strength

    10 minutes

  • +2 more secondary outcomes

Study Arms (3)

Supervised exercise group

EXPERIMENTAL

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.

Other: Combined exercise

Home exercise group

ACTIVE COMPARATOR

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.

Other: Combined exercise

Control group

NO INTERVENTION

Children will not be included in any treatment program. The assessments will be done again 8 weeks later.

Interventions

Combined exerciseOTHER

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.

Home exercise groupSupervised exercise group

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityMotor Activity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, MSc

Study Record Dates

First Submitted

February 19, 2020

First Posted

February 21, 2020

Study Start

October 10, 2019

Primary Completion

August 10, 2022

Study Completion

November 10, 2022

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)