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临床试验/NCT06553430
NCT06553430招募中不适用

Effects of an Aerobic Exercise Intervention on Core Symptoms, Executive Functioning, and Quality of Life in Children With Attention Deficit Hyperactivity Disorder

Harbin Medical University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年11月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
ADHD core symptoms

研究概览

简要总结

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.

详细描述

Purposive sampling method was used to select 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 age, gender, clinical typing, medication use, family proximity, Conners scores and SNAP-IV scores matching 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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
7 Years 至 14 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Children clinically diagnosed with ADHD;
  • •7-14 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

排除标准

  • •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

研究组 & 干预措施

Intervention group

Experimental

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

干预措施: aerobics exercises (Behavioral)

Control group

No Intervention

daily physical activity

结局指标

主要结局

ADHD core symptoms

时间窗: Immediately after the intervention

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.

次要结局

  • executive function(Immediately after the intervention)
  • mental health(Immediately after the intervention)
  • quality of life(Immediately after the intervention)

研究者

发起方
Harbin Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lingrong Xiao

Principal Investigator

Harbin Medical University

研究点 (1)

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