NCT06553430

Brief Summary

Selecting a maternal and child healthcare hospital in Shenzhen City, Guangdong Province, 50 cases of ADHD children as the study subjects, according to the inclusion and exclusion criteria to screen the eligible study subjects, introduction of the purpose and process of the study, informed consent to enrolment, the children were divided into the intervention group and the control group. The experimental group used aerobic exercise, while the control group was given daily physical activity, and general information questionnaires, Conners Parental Symptom Questionnaire, SNAP-IV scale, Stroop Colour Word Test, Rey Complex Graphics Test, Connection Test, Children's Depressive Disorder Self-assessment Scale, Children's Anxious Mood Disorder Screening Scale, Children's Quality of Life Universal Core Scale, and Children's Executive Functioning Questionnaire were assessed.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

November 28, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 14, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

August 14, 2024

Status Verified

August 1, 2024

Enrollment Period

10 months

First QC Date

August 8, 2024

Last Update Submit

August 11, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • ADHD core symptoms

    The Conners Parental Symptom Questionnaire for core symptoms. There are a total of 48 items, including six factors. They are scored on a scale of 0-3, with 0 indicating no problem; 1, occasionally or slightly; 2, frequent or severe; 3, always or very serious. The factor score is the average score of the items within the factor, and the higher the score, the more severe the symptom. The SNAP-IV for ADHD children's inattention and hyperactivity/impulsivity. This scale consists of 26 items and consists of three subscales. Each item is rated on a four point scale from 0 to 3: 0, "never or rarely"; 1, "sometimes"; 2, "often"; 3, 'very common'. The average score of each subscale is the ratio of the total score of the obtained items to the number of items included. Scores from 0-1 are considered normal, 1.1-1.5 are critical, 1.6-2 are moderate, and\>2 are severe. The higher the total score and subscale score, the more severe the damage to the core symptoms of ADHD.

    Immediately after the intervention

Secondary Outcomes (3)

  • executive function

    Immediately after the intervention

  • quality of life

    Immediately after the intervention

  • mental health

    Immediately after the intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

Moderate-intensity aerobic exercise for 30-60 min 3 times per week for 12 weeks and daily physical activity

Behavioral: aerobics exercises

Control group

NO INTERVENTION

daily physical activity

Interventions

Moderate-intensity aerobic exercise for 30-60 min 3 times per week for 12 weeks

Intervention group

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children clinically diagnosed with ADHD;
  • years old;
  • Combined Raven's Test ≥ 80;
  • Not participating in any treatment other than drug therapy;
  • The body can participate in sports training;
  • The type of family intimacy is intimate or above;
  • Voluntarily participate and sign an informed consent form

You may not qualify if:

  • Children with a history of epileptic seizures;
  • Children with other mental or motor disorders;
  • Children with visual impairments;
  • Using other psychotropic drugs;
  • Have other comorbidities;
  • Merge other serious chronic diseases (such as severe heart, brain, kidney, lung, etc.), tumors, etc

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanshan Maternal and Child Health Hospital

Guangzhou, Shenzhen, China

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 8, 2024

First Posted

August 14, 2024

Study Start

November 28, 2023

Primary Completion

October 1, 2024

Study Completion

November 1, 2024

Last Updated

August 14, 2024

Record last verified: 2024-08

Locations