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

2022年5月3日 更新者:Hana Polanska、Charles University, Czech Republic

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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (予想される)

90

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

      • Prague、チェコ
        • 募集
        • Faculty Hospital Vinohrady
        • コンタクト:
      • Prague、チェコ
        • 募集
        • Faculty of Physical Education and Sport
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

65年~80年 (高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的:Therapy by Dance and Movement
Participants assigned to this part take part in Dance Movement Therapy twice a week (90 minutes each) for the duration of three months.
Therapy by dance and movement is based on the principals of movement-analysis by Rudolf Laban and Irmgard Bartenieff. Participants will attend sessions twice a week (90 minutes each) for the duration of three months.
介入なし:Control to Dance Movement Therapy
Participants assigned to this arm take part in no particular activity for the three months.
実験的:Movement Therapy by Tai Chi
Participants assigned to this part take part inTai Chi class twice a week (90 minutes each) for the duration of three months.
Tai Chi is based on somatic approach. Participants will attend sessions twice a week (90 minutes each) for the duration of three months.
介入なし:Control to Tai Chi
Participants assigned to this arm take part in no particular activity for the three months.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Irisin blood levels after 3 months of the intervention
時間枠:baseline to 3 months
Irisin levels measured from 9ml blood samples
baseline to 3 months
Difference in Irisin blood levels between the arms at 3 months
時間枠:3 months
Irisin levels measured from 9ml blood samples
3 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in brain derived neurotrophic factor (BDNF) levels at 3 months
時間枠:baseline to 3 months
BDNF measured from a 9ml blood samples.
baseline to 3 months
Difference in brain derived neurotrophic factor (BDNF) levels at 3 months between the arms
時間枠:3 months
BDNF measured from a 9ml blood samples.
3 months
Change from baseline cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 3 months better outcome
時間枠:baseline to 3 months
ALBA is a validated measure assessing memory. The scale spans 0-12 points with higher number of points signifying better outcome
baseline to 3 months
Difference in cognitive function in the Amnesia Light and Brief Assessment (ALBA) between the arms at 3 months
時間枠:3 months
ALBA is a validated measure assessing memory. The scale spans 0-12 points with higher number of points signifying better outcome
3 months
3か月後の意味単語想起におけるベースライン認知機能からの変化(カテゴリ:動物、1分)
時間枠:ベースラインから 3 か月まで
意味単語の想起は認知機能の尺度であり、結果の範囲は 0 ~ cca 40 で、ポイントが多いほど良い結果を意味します。
ベースラインから 3 か月まで
Difference in cognitive function in Semantic word recollection (category: animals, 1 min) between the arms at 3 months
時間枠:3 months
Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome
3 months
Change in cognitive function in Semantic word recollection (category: letters, 1 min) at 3 months
時間枠:baseline to 3 months
Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome
baseline to 3 months
Difference in cognitive function in Semantic word recollection (category: letters, 1 min) at 3 months between the arms
時間枠:3 months
Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome
3 months
3か月後のレイ聴覚言語学習テスト(RAVLT)におけるベースライン認知機能からの変化
時間枠:ベースラインから 3 か月まで
RAVLT は認知機能の検証済みの尺度であり、8 つの下位尺度があり、それぞれが 0 ~ 15 の範囲であり、年齢依存の集団基準に関連付けられた生のスコアで測定されます。
ベースラインから 3 か月まで
Difference in cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 3 months between the arms
時間枠:3 months
RAVLT is a validated measure of cognitive function, it has 8 subscales, each of them ranging from 0-15, measured in raw scores which are connected to age-dependent population norm
3 months
ウェクスラー成人知能指数第 3 版 (WAIS III) におけるベースライン認知機能の変化 - 3 か月後の「記号」サブテスト
時間枠:ベースラインから 3 か月まで
WAIS III のサブテスト「シンボル」は認知機能の検証済みの尺度であり、ポイント スケールの範囲は 0 ~ 133 であり、ポイントの達成が大きいほど結果が良好であることを示します。
ベースラインから 3 か月まで
Difference in cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 3 months between the arms
時間枠:3 months
The WAIS III, subtest "Symbols" is a validated measure of cognitive function, the point scale ranges from 0-133 with larger point attainment signalling better outcome
3 months
3か月後のトレイルメイキングテスト(TMT)、パートAおよびBにおけるベースライン認知機能の変化
時間枠:ベースラインから 3 か月まで
TMT は認知機能の検証された尺度であり、完了までの時間が測定されます。
ベースラインから 3 か月まで
Difference in cognitive function in Trail Making Test (TMT), Parts A & B at 3 months between the arms
時間枠:3 months
The TMT is a validated measure of cognitive function, the time upon completion is measured
3 months
Change in the Clock Drawing Test at 3 months
時間枠:baseline to 3 months
A validated measure where participant is asked to draw a clock face with the time 23:20
baseline to 3 months
Difference in the Clock Drawing Test at 3 months between the arms
時間枠:3 months
A validated measure where participant is asked to draw a clock face with the time 23:20
3 months
Change in Line Picture Production test at 3 months
時間枠:baseline to 3 months
Participant is asked to produce as many as possible pictures consisting from 4 straight lines in 1 minute.
baseline to 3 months
Difference in Line Picture Production test at 3 months between the arms
時間枠:3 months
Participant is asked to produce as many as possible pictures consisting from 4 straight lines in 1 minute.
3 months
Change in Picture Naming and Immediate Recall test (PICNIR) at 3 months
時間枠:Baseline to 3 months
Cognitive measure where participants first write down names of 20 pictures and then are asked to recall these names within 1 minute
Baseline to 3 months
Difference in Picture Naming and Immediate Recall test (PICNIR) at 3 months between the arms
時間枠:3 months
Cognitive measure where participants first write down names of 20 pictures and then are asked to recall these names within 1 minute.
3 months
Change in baseline mood in Geriatric Depression Scale at 3 months.
時間枠:baseline to 3 months
A self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome.
baseline to 3 months
Difference in mood in Geriatric Depression Scale at 3 months.
時間枠:3 months
A self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome.
3 months
3か月後の機能状態アンケート(原語略称:主観的FAQ-CZ)で自己申告したベースライン自給率からの変化
時間枠:ベースラインから 3 か月まで
FAQ-CZ は自給自足度の自己報告尺度であり、0 ~ 30 のスケールで測定され、到達点が高いほど結果が悪化することを示します。
ベースラインから 3 か月まで
Difference in self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 3 months between the arms
時間枠:3 months
FAQ-CZ is a self-report measure of self-sufficiency, it is measured on a scale of 0-30 with higher point attainment signalling worse outcome
3 months
Change in Sarcopenia at 3 months
時間枠:baseline to 3 months
An ultrasound imaging method for diagnosing sarcopenia based on changes in muscle geometric proportions: muscle thickness (MT), pennation angle (PA), fiber length (FL), and ultrasound sarcopenic index (USI) calculated as FL/MT.
baseline to 3 months
Difference in Sarcopenia at 3 months between the arms
時間枠:3 months
An ultrasound imaging method for diagnosing sarcopenia based on changes in muscle geometric proportions: muscle thickness (MT), pennation angle (PA), fiber length (FL), and ultrasound sarcopenic index (USI) calculated as FL/MT.
3 months
Change in knee extensor isometric strength and static fatigue at 3 months
時間枠:baseline to 3 months
Knee extensor isometric strength and static fatigue were measured by a stationary dynamometer: isometric torque (Nm), and fatigue index calculated as the Area Under Force vs. Time Curve of right knee extensor during a sustained 30 s maximal voluntary muscle contraction. Handgrip strength.
baseline to 3 months
Difference in knee extensor isometric strength and static fatigue at 3 months between the arms
時間枠:3 months
Knee extensor isometric strength and static fatigue were measured by a stationary dynamometer: isometric torque (Nm), and fatigue index calculated as the Area Under Force vs. Time Curve of right knee extensor during a sustained 30 s maximal voluntary muscle contraction. Handgrip strength.
3 months
Change in short physical performance battery (SPPB) at 3 months
時間枠:baseline to 3 months
The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests. It is used as a predictive tool for possible disability and can aid in the monitoring of function in older people.
baseline to 3 months
Difference in short physical performance battery (SPPB) at 3 months between the arms
時間枠:3 months
The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests. It is used as a predictive tool for possible disability and can aid in the monitoring of function in older people.
3 months
Change in Body Composition at 3 months
時間枠:baseline to 3 months
Body composition by a bioelectrical impedance analysis (BIA).
baseline to 3 months
Difference in Body Composition at 3 months between the arms
時間枠:3 months
Body composition by a bioelectrical impedance analysis (BIA).
3 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2021年8月1日

一次修了 (予想される)

2023年1月30日

研究の完了 (予想される)

2023年1月30日

試験登録日

最初に提出

2022年5月3日

QC基準を満たした最初の提出物

2022年5月3日

最初の投稿 (実際)

2022年5月5日

学習記録の更新

投稿された最後の更新 (実際)

2022年5月5日

QC基準を満たした最後の更新が送信されました

2022年5月3日

最終確認日

2022年5月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • GAUK/268321

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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