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临床试验/NCT05363228
NCT05363228Unknown不适用

The Effect of Tai Chi and Therapy by Dance and Movement on Blood Irisin Levels in Older Adults Over 65 Years of Age.

Charles University, Czech Republic2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
2
主要终点
Change in Irisin blood levels after 3 months of the intervention

研究概览

简要总结

The aim of this project is to estimate the effects of therapy with dance and movement and Tai Chi on irisin plasma levels, a myokine with proven neuroprotective effects, in the context of baseline levels of cognitive function and physical performance in seniors over 65 years of age.

It is empirically verified that physical activity can have a positive effect on cognitive function even in individuals with mild cognitive impairment. There may be a number of reasons why this is the case. Recently, research investigating the relationship between the secretion of certain myokines and their neuroprotective effects has gained importance. One of these myokines is irisin, which has recently been shown to have beneficial effects on the CNS by upregulating the expression of Brain Derived Neurotrophic Factor (BDNF) in the hippocampus in an animal model. Increased irisin levels as a consequence of exercise have recently been partially demonstrated in humans. What type of physical activity is most effective in terms of its effect on cognitive function in humans is another important scientific challenge. The possibility of influencing endocrine secretion of bioactive substances with proven effects on synaptic plasticity, neurogenesis and neuroprotection through effective therapies may help to combat neurodegenerative diseases, the prevalence of which is increasing with the average age of the population. According to Alzheimer's Disease International, 50 million people worldwide were affected by some form of neurodegenerative disease in 2017. The number of people affected is still rising. It is predicted that this number will reach 75 million sufferers by 2030 (https://www.alz.co.uk/research/statistics). Alzheimer's disease and multiple sclerosis are the two most common manifestations of neurodegenerative diseases. The effect of therapy with dance and movement and the effect of Tai Chi on blood irisin levels in the context of cognitive function and physical performance levels, has not yet been conclusively demonstrated.

详细描述

It is empirically verified that physical activity can have a positive effect on cognitive function even in individuals with mild cognitive impairment. There may be a number of reasons why this is the case. Recently, research investigating the relationship between the secretion of certain myokines and their neuroprotective effects has gained importance. One of these myokines is irisin, which has recently been shown to have beneficial effects on the CNS by upregulating the expression of Brain Derived Neurotrophic Factor (BDNF) in the hippocampus in an animal model. Increased irisin levels as a consequence of exercise have recently been partially demonstrated in humans. What type of physical activity is most effective in terms of its effect on cognitive function in humans is another important scientific challenge. The possibility of influencing endocrine secretion of bioactive substances with proven effects on synaptic plasticity, neurogenesis and neuroprotection through effective therapies may help to combat neurodegenerative diseases, the prevalence of which is increasing with the average age of the population. According to Alzheimer's Disease International, 50 million people worldwide were affected by some form of neurodegenerative disease in 2017. The number of people affected is still rising. It is predicted that this number will reach 75 million sufferers by 2030 (https://www.alz.co.uk/research/statistics). Alzheimer's disease and multiple sclerosis are the two most common manifestations of neurodegenerative diseases. The effect of therapy with dance and movement and the effect of Tai Chi on blood irisin levels in the context of cognitive function and physical performance levels, has not yet been conclusively demonstrated. The aim of this project is to estimate the effects of therapy with dance and movement and Tai Chi on irisin plasma levels, a myokine with proven neuroprotective effects, in the context of baseline levels of cognitive function and physical performance in seniors over 65 years of age.

Implementation of the project: the following personal data will be collected at the Consultation Room for Memory Disorders, AD Centrum Fakultní at the Královské Vinohrady Hospital (PPP AD FNKV): age, weight, height, sex, education, a brief medical history will be taken, current illness and current treatment will be determined, and a basic pharmacological and toxicological history will be taken. The probands who will be admitted to the experimental part of the project, based on the initial screening at the PPP AD FNKV, will have their cognitive function tested and 9 ml of venous blood drawn before and after the intervention at the PPP AD FNKV, and strength and physical performance tested at the UK FTVS. Thereafter, probands will be randomized to either the intervention groups or the control group. This randomized controlled trial will compare the effects of a movement and dance therapy based on Bartenieff fundamentals and the other type of intervention will be implemented as Tai Chi exercises. Both types of exercises are designed to place a greater emphasis on body perception, so that there is a connection between musculoskeletal coordination and movement in conjunction with an emotional experience focused on the ability to perceive bodily signals. This approach will activate cognitive functions more. The experimental part will be carried out with a time intensity of twice a week (90 min) for 12 weeks - all in two phases 09-2021 to 12-2021 and 09-2022 to 12-2022. The control group will be implemented on the principle of wait-list control group.

Characteristics of research participants: Based on the power analysis, we expect to recruit approximately 90 participants (age ≥ 65 - ≤ 80 years) from outpatients of the PPP AD FNKV and U3V UK FTVS participants, or other interested persons from Prague 6.

Individuals with advanced cognitive impairment, regular use of medications affecting cognitive performance, antidepressants, anxiolytics, and individuals with uncorrected hypertension and ischemic heart disease, acutee (especially infectious) disease, musculoskeletal disorders and chronic diseases limiting physical activity, as well as individuals in recovery after illness or injury cannot take part in the study.

Ethical aspects of research: The research will be conducted on seniors who will be enrolled in the research on the basis of voluntary informed consent. Since movement therapy has no negative side effects, it is an ethically conflict-free research from this perspective. On the other hand, a great benefit to society can be expected, in particular the development of a suitable exercise regimen that will be applicable to other age groups. Since the elderly are a specific and relatively easy to influence group, they will be adequately informed about the purpose of the research, and the benefits of the research for them and for the elderly population as a whole will be explained. Before signing the informed consent, the clarity and understanding of the information provided will be carefully checked.

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
Single (Outcomes Assessor)

入排标准

年龄范围
65 Years 至 80 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Is 65 years - 80 years in age
  • His/her native language is Czech
  • Is willing to visit the testing centre two times within 3-4 months
  • Is willing to provide blood samples twice
  • Is willing to take part in the movement therapy intervention
  • is self-sufficient (handling finances, travelling without a chaperone, administration of medication, correct phone usage, filling forms, meal preparation)
  • Has good vision; Can read and write, glasses are acceptable
  • Has good hearing to hear and understand all instructions during examination
  • Can walk well (walking aids are acceptable) to attend all the examinations and move well enough to take part in the movement therapy

排除标准

  • Had been treated/Is currently being treated for the following psychiatric disorders: alcohol/medication/drug of abuse dependance, schizophrenia, psychotic disorder, bipolar disorder
  • Had larger physical imparment which would interfere with the ability to take part in the Dance Movement and Tai Chi interventions
  • Had severe neurological difficulties (epilepsy, stroke, severe head trauma, meningitis in the past 10 years, brain surgery, brain tumour, prolonged period(s) in an unconscious state - excluding general anaesthesia)
  • Underwent a surgery/procedure under general anaesthesia in the past three years or has a planned procedure/surgery under general anaesthesia in the next 6 months over the course of this trial
  • Is taking medication for depression or low mood

结局指标

主要结局

Change in Irisin blood levels after 3 months of the intervention

时间窗: baseline to 3 months

Irisin levels measured from 9ml blood samples

Difference in Irisin blood levels between the arms at 3 months

时间窗: 3 months

Irisin levels measured from 9ml blood samples

次要结局

  • Difference in brain derived neurotrophic factor (BDNF) levels at 3 months between the arms(3 months)
  • Change from baseline cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 3 months better outcome(baseline to 3 months)
  • Difference in cognitive function in the Amnesia Light and Brief Assessment (ALBA) between the arms at 3 months(3 months)
  • Change from baseline cognitive function in Semantic word recollection (category: animals, 1 min) at 3 months(baseline to 3 months)
  • Difference in cognitive function in Semantic word recollection (category: animals, 1 min) between the arms at 3 months(3 months)
  • Change in Picture Naming and Immediate Recall test (PICNIR) at 3 months(Baseline to 3 months)
  • Difference in self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 3 months between the arms(3 months)
  • Change in Sarcopenia at 3 months(baseline to 3 months)
  • Difference in cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 3 months between the arms(3 months)
  • Change in baseline cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 3 months(baseline to 3 months)
  • Difference in cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 3 months between the arms(3 months)
  • Change in baseline cognitive function in Trail Making Test (TMT), Parts A & B at 3 months(baseline to 3 months)
  • Difference in cognitive function in Trail Making Test (TMT), Parts A & B at 3 months between the arms(3 months)
  • Change in Line Picture Production test at 3 months(baseline to 3 months)
  • Change in cognitive function in Semantic word recollection (category: letters, 1 min) at 3 months(baseline to 3 months)
  • Difference in cognitive function in Semantic word recollection (category: letters, 1 min) at 3 months between the arms(3 months)
  • Difference in the Clock Drawing Test at 3 months between the arms(3 months)
  • Difference in Line Picture Production test at 3 months between the arms(3 months)
  • Difference in Picture Naming and Immediate Recall test (PICNIR) at 3 months between the arms(3 months)
  • Change in brain derived neurotrophic factor (BDNF) levels at 3 months(baseline to 3 months)
  • Change from baseline cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 3 months(baseline to 3 months)
  • Change in the Clock Drawing Test at 3 months(baseline to 3 months)
  • Change in baseline mood in Geriatric Depression Scale at 3 months.(baseline to 3 months)
  • Change in knee extensor isometric strength and static fatigue at 3 months(baseline to 3 months)
  • Difference in knee extensor isometric strength and static fatigue at 3 months between the arms(3 months)
  • Difference in short physical performance battery (SPPB) at 3 months between the arms(3 months)
  • Change in Body Composition at 3 months(baseline to 3 months)
  • Difference in Sarcopenia at 3 months between the arms(3 months)
  • Difference in mood in Geriatric Depression Scale at 3 months.(3 months)
  • Change from baseline self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 3 months(baseline to 3 months)
  • Change in short physical performance battery (SPPB) at 3 months(baseline to 3 months)
  • Difference in Body Composition at 3 months between the arms(3 months)

研究者

发起方
Charles University, Czech Republic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hana Polanska

Researcher

Charles University, Czech Republic

研究点 (2)

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