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临床试验/CTRI/2024/07/070954
CTRI/2024/07/070954已完成不适用

Effect of Brain Gym Exercises on cognitive performance and Brain Derived Neurotrophic Factor levels in Mobile Addicts - A Pre- Post Experimental Study

KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2024年7月30日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
39
试验地点
1
主要终点
Brain Derived Neurotrophic Factor

研究概览

简要总结

Smartphone addiction is the excessive use of smartphones despite awareness of their consequences, leading to withdrawal symptoms and negative effects on mental health. Symptoms include problems in dangerous situations, social conflicts, loss of interest in other activities, and continuing behaviors despite negative effects. Excessive smartphone use can lead to stress, depression, sleep deprivation, decreased academic performance, reduced cognitive capacity, dissatisfaction with life, and poor quality of life. Neuroplasticity, the ability of the brain to change its neural structure and function in response to environmental stimuli, is crucial for brain health. High levels of BDNF suggest better brain health. Cognitive function, which includes knowledge, attention, memory, judgment, language ability, computing power, space-time orientation ability, and reasoning ability, can be affected by smartphone use. Researchers have found that exercises like aerobic exercises, cognitive training, mindfulness, resistance training, dual-task training, neurobic exercises, and brain gym exercises have an impact on various brain functions in both patients with neurological conditions and healthy individuals. Brain Gym, a structured nonaerobic physical exercise intervention, is believed to improve perception and stimulate the brain hemispheres, promoting faster communication and higher-level reasoning.

AIM:

To determine the effect of Brain Gym Exercises on cognitive performance and Brain Derived Neurotrophic Factor levels in Mobile Addicts.

OBJECTIVE:

To determine the effect of Brain Gym Exercises on cognitive performance using game based app and on neuroplasticity by studying Brain Derived Neurotrophic Factor levels in Mobile Addicts.

HYPOTHESIS

  • NULL HYPOTHESIS:

Brain Gym Exercises may not have an effect on cognitive performances and Brain Derived Neurotrophic Factor levels in Mobile Addicts.

  • ALTERNATE HYPOTHESIS:

Brain Gym Exercises may have an effect on cognitive performances and Brain Derived Neurotrophic Factor levels in Mobile Addicts.

Study Type: Pre and Post Experimental Trial

Study Design: Interventional Study

Target Population: Mobile Addicts  of all genders

Age Group: 18-25 years

Duration of Study: 12 months

Sampling Design: Non- Probability Sampling

Sampling technique: Convenience sampling

Sampling Size: 39

OUTCOME MEASURES

·         BDNF levels- BDNF is a neurotrophin which plays role in neuronal survival, neurogenesis, synaptogenesis, and neuroplasticity.

A higher level in BDNF would be related to better brain health.

It is been reported that BDNF can across the blood-brain barrier, which is the membrane between brain and bloodstream, and there was a positive correlation between serum and cortical BDNF levels.

Therefore, the peripheral measurement of BDNF could be used to indicate the central BDNF levels

·         Cognition scores- To check the cognition a game based app named CogniFit is used.

Cronbach’s Alpha –above 7

The cognitive score is an aggregate measure of the current cognitive strength of different cognitive skills. The minimum cognitive score is 0 and the maximum is 800.

Score between 0 - 200: Below the average of your age.

Score between 200 - 400: Low scores, although within the average.

Score between 400 - 600: High scores within the average.

Score between 600 - 800: Cognitive situations above the average.

PROCEDURE

·         Prior to the commencement of the study, Ethical clearance will be obtained from institutional ethical committee.

·         According to ICMR guidelines the following research will be conducted as it involves human participation.

·         The study will be registered in Clinical Trials Registry- India (CTRI) after Ethical Clearance.

·         Subjects who fulfill the inclusion criteria will be recruited for the study after they provide the written consent for the same.

·         Initially, the cognition scores and BDNF levels of each participants obtained.

·         Then, the subjects will undergo intervention of Brain Gym Exercises. Subjects will be given detailed information about brain gym exercises. All the exercises will be taught to the participants.

·         A set of 10 exercises will be given 3 times a week for 4 weeks.10

·         The Brain Gym Exercises include

Marching at place

1 min

|Cross Crawl

2 min (5 sets 8 reps)

|Positive points

1 min (10 reps)

|Step touch

5 mins (30 reps)

|Neck Circles

2 mins (20 reps)

  

Cook’s Hook ups

 5 mins

  |Brain Buttons

 2 mins (10 reps)

  |Thinking Caps

 1 min (15 reps)

  |Lazy Eight

 1 min (5 sets)

  |Trace X

 2 mins (10 reps)

 Â·         Post Intervention Cognition scores and BDNF levels will be obtained.

·         The data collected will be statistically analyzed.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 25.00 Year(s)(—)
性别
All

入选标准

  • Willingness of Participants, Mobile addicts of age group 18-25 of all genders with scores more than 31 in females n 33 in males in SV-SAS scale, Cognitive scores less than 400 in CogniFit app.

排除标准

  • Individual with preexisting neurological condition Any auditory or visual disorder Previous history of depression and psychosis On medications for psychological conditions Fear of needles and/or blood.

结局指标

主要结局

Brain Derived Neurotrophic Factor

时间窗: Baseline and 4 weeks

Cognition Score

时间窗: Baseline and 4 weeks

次要结局

未报告次要终点

研究者

发起方
KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Chilka Ruchita sushilkumar

KAHER Institute of Physiotherapy, Belagavi

研究点 (1)

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