- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05363228
The Effect of Tai Chi and Therapy by Dance and Movement on Blood Irisin Levels in Older Adults Over 65 Years of Age.
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.
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Hana Polanska
- 이메일: hpolanska@ftvs.cuni.cz
연구 장소
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Prague, 체코
- 모병
- Faculty Hospital Vinohrady
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연락하다:
- Ales Bartos, Prof, MuDr., Ph.D.
- 이메일: ales.bartos@fnkv.cz
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Prague, 체코
- 모병
- Faculty of Physical Education and Sport
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연락하다:
- Michal Steffl, doc.
- 전화번호: +42O778701882
- 이메일: steffl@ftvs.cuni.cz
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 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.
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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.
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간섭 없음: Control to Dance Movement Therapy
Participants assigned to this arm take part in no particular activity for the three months.
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실험적: 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.
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Tai Chi is based on somatic approach.
Participants will attend sessions twice a week (90 minutes each) for the duration of three months.
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간섭 없음: Control to Tai Chi
Participants assigned to this arm take part in no particular activity for the three months.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in Irisin blood levels after 3 months of the intervention
기간: baseline to 3 months
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Irisin levels measured from 9ml blood samples
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baseline to 3 months
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Difference in Irisin blood levels between the arms at 3 months
기간: 3 months
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Irisin levels measured from 9ml blood samples
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3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in brain derived neurotrophic factor (BDNF) levels at 3 months
기간: baseline to 3 months
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BDNF measured from a 9ml blood samples.
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baseline to 3 months
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Difference in brain derived neurotrophic factor (BDNF) levels at 3 months between the arms
기간: 3 months
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BDNF measured from a 9ml blood samples.
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3 months
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Change from baseline cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 3 months better outcome
기간: baseline to 3 months
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ALBA is a validated measure assessing memory.
The scale spans 0-12 points with higher number of points signifying better outcome
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baseline to 3 months
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Difference in cognitive function in the Amnesia Light and Brief Assessment (ALBA) between the arms at 3 months
기간: 3 months
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ALBA is a validated measure assessing memory.
The scale spans 0-12 points with higher number of points signifying better outcome
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3 months
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3개월에 의미론적 단어 기억(카테고리: 동물, 1분)에서 기준선 인지 기능의 변화
기간: 기준선에서 3개월
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의미론적 단어 기억은 인지 기능의 척도이며 결과 범위는 0-cca 40이며 점수가 높을수록 더 나은 결과를 나타냅니다.
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기준선에서 3개월
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Difference in cognitive function in Semantic word recollection (category: animals, 1 min) between the arms at 3 months
기간: 3 months
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Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome
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3 months
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Change in cognitive function in Semantic word recollection (category: letters, 1 min) at 3 months
기간: baseline to 3 months
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Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome
|
baseline to 3 months
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Difference in cognitive function in Semantic word recollection (category: letters, 1 min) at 3 months between the arms
기간: 3 months
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Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome
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3 months
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3개월에 Rey 청각 언어 학습 테스트(RAVLT)의 기준 인지 기능에서 변화
기간: 기준선에서 3개월
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RAVLT는 인지 기능의 검증된 척도이며, 8개의 하위 척도가 있으며 각 하위 척도는 0-15 범위이며 연령에 따른 인구 표준과 연결된 원시 점수로 측정됩니다.
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기준선에서 3개월
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Difference in cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 3 months between the arms
기간: 3 months
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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
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3 months
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Wechsler 성인 지능 척도 제3판(WAIS III)의 기본 인지 기능 변화 - 3개월 후 "기호" 하위 검사
기간: 기준선에서 3개월
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WAIS III, 하위 테스트 "Symbols"는 인지 기능의 검증된 척도이며 점수 척도 범위는 0-133이며 점수가 클수록 더 나은 결과를 나타냅니다.
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기준선에서 3개월
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Difference in cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 3 months between the arms
기간: 3 months
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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
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3 months
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3개월 시점의 트레일 메이킹 테스트(TMT), 파트 A 및 B의 기본 인지 기능 변화
기간: 기준선에서 3개월
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TMT는 인지 기능의 검증된 척도이며 완료 시 시간이 측정됩니다.
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기준선에서 3개월
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Difference in cognitive function in Trail Making Test (TMT), Parts A & B at 3 months between the arms
기간: 3 months
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The TMT is a validated measure of cognitive function, the time upon completion is measured
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3 months
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Change in the Clock Drawing Test at 3 months
기간: baseline to 3 months
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A validated measure where participant is asked to draw a clock face with the time 23:20
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baseline to 3 months
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Difference in the Clock Drawing Test at 3 months between the arms
기간: 3 months
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A validated measure where participant is asked to draw a clock face with the time 23:20
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3 months
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Change in Line Picture Production test at 3 months
기간: baseline to 3 months
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Participant is asked to produce as many as possible pictures consisting from 4 straight lines in 1 minute.
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baseline to 3 months
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Difference in Line Picture Production test at 3 months between the arms
기간: 3 months
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Participant is asked to produce as many as possible pictures consisting from 4 straight lines in 1 minute.
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3 months
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Change in Picture Naming and Immediate Recall test (PICNIR) at 3 months
기간: Baseline to 3 months
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Cognitive measure where participants first write down names of 20 pictures and then are asked to recall these names within 1 minute
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Baseline to 3 months
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Difference in Picture Naming and Immediate Recall test (PICNIR) at 3 months between the arms
기간: 3 months
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Cognitive measure where participants first write down names of 20 pictures and then are asked to recall these names within 1 minute.
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3 months
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Change in baseline mood in Geriatric Depression Scale at 3 months.
기간: baseline to 3 months
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A self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome.
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baseline to 3 months
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Difference in mood in Geriatric Depression Scale at 3 months.
기간: 3 months
|
A self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome.
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3 months
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3개월 시점에 기능 상태 설문지(원문 약어: 주관적 FAQ-CZ)에 자가 보고된 기본 자급자족과의 변화
기간: 기준선에서 3개월
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FAQ-CZ는 자급자족에 대한 자가 보고 척도이며 0~30점 척도로 측정되며 높은 점수 달성은 더 나쁜 결과를 나타냅니다.
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기준선에서 3개월
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Difference in self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 3 months between the arms
기간: 3 months
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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
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3 months
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Change in Sarcopenia at 3 months
기간: baseline to 3 months
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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.
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baseline to 3 months
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Difference in Sarcopenia at 3 months between the arms
기간: 3 months
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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.
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3 months
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Change in knee extensor isometric strength and static fatigue at 3 months
기간: baseline to 3 months
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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.
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baseline to 3 months
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Difference in knee extensor isometric strength and static fatigue at 3 months between the arms
기간: 3 months
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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.
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3 months
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Change in short physical performance battery (SPPB) at 3 months
기간: baseline to 3 months
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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.
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baseline to 3 months
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Difference in short physical performance battery (SPPB) at 3 months between the arms
기간: 3 months
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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.
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3 months
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Change in Body Composition at 3 months
기간: baseline to 3 months
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Body composition by a bioelectrical impedance analysis (BIA).
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baseline to 3 months
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Difference in Body Composition at 3 months between the arms
기간: 3 months
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Body composition by a bioelectrical impedance analysis (BIA).
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3 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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