- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Hana Polanska
- E-post: hpolanska@ftvs.cuni.cz
Studieorter
-
-
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Prague, Tjeckien
- Rekrytering
- Faculty Hospital Vinohrady
-
Kontakt:
- Ales Bartos, Prof, MuDr., Ph.D.
- E-post: ales.bartos@fnkv.cz
-
Prague, Tjeckien
- Rekrytering
- Faculty of Physical Education and Sport
-
Kontakt:
- Michal Steffl, doc.
- Telefonnummer: +42O778701882
- E-post: steffl@ftvs.cuni.cz
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
|
Inget ingripande: Control to Dance Movement Therapy
Participants assigned to this arm take part in no particular activity for the three months.
|
|
Experimentell: 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.
|
Inget ingripande: Control to Tai Chi
Participants assigned to this arm take part in no particular activity for the three months.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in Irisin blood levels after 3 months of the intervention
Tidsram: 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
Tidsram: 3 months
|
Irisin levels measured from 9ml blood samples
|
3 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in brain derived neurotrophic factor (BDNF) levels at 3 months
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Förändring från kognitiv baslinjefunktion i semantiskt ordminne (kategori: djur, 1 min) efter 3 månader
Tidsram: baslinje till 3 månader
|
Semantisk ordminne är ett mått på kognitiv funktion, resultaten sträcker sig från 0-cca 40, fler poäng betyder bättre resultat
|
baslinje till 3 månader
|
Difference in cognitive function in Semantic word recollection (category: animals, 1 min) between the arms at 3 months
Tidsram: 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
Tidsram: 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
Tidsram: 3 months
|
Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome
|
3 months
|
Förändring från baslinjens kognitiv funktion i Rey Auditory Verbal Learning Test (RAVLT) efter 3 månader
Tidsram: baslinje till 3 månader
|
RAVLT är ett validerat mått på kognitiv funktion, den har 8 subskalor, var och en av dem sträcker sig från 0-15, mätt i råpoäng som är kopplade till åldersberoende befolkningsnorm
|
baslinje till 3 månader
|
Difference in cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 3 months between the arms
Tidsram: 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
|
Förändring i kognitiv baslinjefunktion i Wechsler Adult Intelligence Scale, tredje upplagan (WAIS III) - "Symbols" deltest efter 3 månader
Tidsram: baslinje till 3 månader
|
WAIS III, deltest "Symboler" är ett validerat mått på kognitiv funktion, poängskalan sträcker sig från 0-133 med större poäng som signalerar bättre resultat
|
baslinje till 3 månader
|
Difference in cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 3 months between the arms
Tidsram: 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
|
Förändring i kognitiv baslinjefunktion i Trail Making Test (TMT), Delarna A & B efter 3 månader
Tidsram: baslinje till 3 månader
|
TMT är ett validerat mått på kognitiv funktion, tiden efter avslutning mäts
|
baslinje till 3 månader
|
Difference in cognitive function in Trail Making Test (TMT), Parts A & B at 3 months between the arms
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
Tidsram: 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.
Tidsram: 3 months
|
A self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome.
|
3 months
|
Förändring från baslinjens självförsörjning självrapporterad i enkät om funktionellt tillstånd (förkortning på originalspråk: subjektiv FAQ-CZ) efter 3 månader
Tidsram: baslinje till 3 månader
|
FAQ-CZ är ett självrapporterande mått på självförsörjning, det mäts på en skala från 0-30 med högre poäng som signalerar sämre resultat
|
baslinje till 3 månader
|
Difference in self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 3 months between the arms
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 3 months
|
Body composition by a bioelectrical impedance analysis (BIA).
|
3 months
|
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Först inskickad som uppfyllde QC-kriterierna
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