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临床试验/NCT04641429
NCT04641429Unknown不适用

Neuroplasticity: The Effects of Exercise Training on Cognitive and Affective Functioning of Older People

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年10月2日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Mean change from Baseline in affective processing by the Emotion Processing Task at 12 weeks

研究概览

简要总结

This study investigates the effects of exercise on older people's cognitive and affective functions, and the possible underlying neurobiological pathways.

详细描述

Population aging is accelerating. The socioeconomic burden associated with an aging population calls for timely action for promoting brain health. The human brain has the capacity for plastic reorganization through learning and experience. Physical activity could induce plasticity and is important in the prevention of functional decline and increased survival. In this study, the effects of Qigong and stretching exercise on affective and cognitive function among the healthy elderly are investigated. This study is proposed to invite 200 participants (100 in each intervention condition). The investigators acquire data from questionnaires, assessments, neurocognitive tests, magnetic resonance imaging and blood samples at baseline (before the intervention) and post-intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

盲法说明

Blinding the participants to the allocation is impossible due to the nature of intervention. But prior to the first training session, participants have no knowledge on which type of training they are going to receive.

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least finished primary school;
  • Have normal or corrected-to-normal vision and hearing;
  • Ability to do exercise;
  • Right-hand dominance;
  • Normal cognitive ability as assessed by the Montreal Cognitive Assessment Hong Kong version (HK-MoCA).

排除标准

  • Abmormal anxiety or depression mood as measured by the Hospital Anxiety and Depression Scale;
  • Current diagnosis or history of neurological or psychological conditions, such as substance abuse, psychotic disorders, or affective disorders;
  • Current diagnosis or history of substance/alcohol abuse;
  • Contraindications for MRI scanning (e.g. implanted metal);
  • People who regularly practice any qigong, Tai Chi or similar exercise or meditation within 6 months before study;
  • People who regularly practice moderate to high intensity physical exercise within 6 months before study. The operational definition of 'regular practice' is three times a week or more, at least 30 mins per time for at least 3 months.

结局指标

主要结局

Mean change from Baseline in affective processing by the Emotion Processing Task at 12 weeks

时间窗: from baseline to end of intervention at 12 weeks

Changes of affective stimuli processing are measured by the Emotion Processing Task from baseline to end of intervention at 12 weeks.

Mean change from Baseline in sustained attention scores on the Continuous Performance Test at 12 Weeks

时间窗: from baseline to end of intervention at 12 weeks

Changes of sustained attention scores are measured by the Continuous Performance Test from baseline to end of intervention at 12 weeks. The accuracy scores on the Continuous Performance Test range from 0-100%, with a higher score indicating better performance.

Mean change from Baseline in blood levels of brain-derived neurotrophic factor at 12 Weeks

时间窗: from baseline to end of intervention at 12 weeks

Changes of blood biomarker levels of brain-derived neurotrophic factor are measured from baseline to end of intervention at 12 weeks.

Mean change from Baseline in cognitive processing speed scores on the Symbol Digit Modalities Test at 12 Weeks

时间窗: from baseline to end of intervention at 12 weeks

Changes of cognitive processing speed scores are measured by the Symbol Digit Modalities Test from baseline to end of intervention at 12 Weeks. Scores on the Symbol Digit Modalities Test range from 0-90, with a higher score indicating better performance.

Mean change from Baseline in trait affect scores on the Chinese Affect Scale at 12 Weeks

时间窗: from baseline to end of intervention at 12 weeks

Changes of trait positive affect and negative affect are measured by the Chinese Affect Scale from baseline to end of intervention at 12 weeks. Positive and negative affect scores on Chinese Affect Scale both range from 10-50, with a higher score indicating higher positive/negative affect.

Mean change from Baseline in working memory scores on the Digit Span-Backward Test at 12 Weeks

时间窗: from baseline to end of intervention at 12 weeks

Changes of working memory scores are measured by the Digit Span Backward Test from baseline to end of intervention at 12 weeks. Scores on the Digit Span-Backward test range from 2-13, with a higher score indicating better performance.

Mean change from Baseline in blood levels of cortisol at 12 Weeks

时间窗: from baseline to end of intervention at 12 weeks

Changes of blood biomarker levels of cortisol are measured from baseline to end of intervention at 12 weeks.

Mean change from Baseline in blood levels of interleukin-6 at 12 Weeks

时间窗: from baseline to end of intervention at 12 weeks

Changes of blood biomarker levels of interleukin-6 are measured from baseline to end of intervention at 12 weeks.

Mean change from Baseline in language scores on the Rapid Naming Test at 12 Weeks

时间窗: from baseline to end of intervention at 12 weeks

Changes of language scores are measured by the Rapid Naming Test from baseline to end of intervention at 12 weeks. Scores on the Rapid Naming Test range from 0-36, with a higher score indicating better performance.

Mean change from Baseline in brain structure by magnetic resonance imaging at 12 Weeks

时间窗: from baseline to end of intervention at 12 weeks

Changes of brain structure are measured by T1-weighted magnetic resonance imaging from baseline to end of intervention at 12 Weeks.

Mean change from Baseline in telomerase activity at 12 Weeks

时间窗: from baseline to end of intervention at 12 weeks

Changes of blood measurement of telomerase activity are measured from baseline to end of intervention at 12 weeks.

Mean change from Baseline in brain function by functional magnetic resonance imaging at 12 Weeks

时间窗: from baseline to end of intervention at 12 weeks

Changes of brain function are measured by functional magnetic resonance imaging from baseline to end of intervention at 12 Weeks.

次要结局

  • Mean change from Baseline in perceived stress scores on the Perceived Stress Scale at 12 weeks(from baseline to end of intervention at 12 weeks)
  • Mean change from Baseline in insomnia severity scores on the Insomnia Severity Index at 12 weeks(from baseline to end of intervention at 12 weeks)
  • Mean change from Baseline in perceived loneliness scores on the UCLA Loneliness Scale at 12 weeks(from baseline to end of intervention at 12 weeks)
  • Mean change from Baseline in quality of life scores on the WHO Quality of Life-BREF scale at 12 weeks(from baseline to end of intervention at 12 weeks)
  • Mean change from Baseline in emotion reactivity scores on the Emotion Reactivity Scale at 12 weeks(from baseline to end of intervention at 12 weeks)
  • Mean change from Baseline in somatization scores on the somatization subscale of Symptom Check-List-90 at 12 weeks(from baseline to end of intervention at 12 weeks)
  • Mean change from Baseline in quality of sleep on the Pittsburg Seep Quality Index at 12 weeks(from baseline to end of intervention at 12 weeks)
  • Mean change from Baseline in depression and anxiety scores on the Hospital Anxiety and Depression Scale at 12 weeks(from baseline to end of intervention at 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Tatia Mei-chun LEE

Chair Professor

The University of Hong Kong

研究点 (1)

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