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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05363228
• Other study ID #: GAUK/268321
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: January 30, 2023

Study information

• Verified date: May 2022
• Source: Charles University, Czech Republic
• Contact: Hana Polanska
• Email: hpolanska[@]ftvs.cuni.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Cognitive Impairment
• Memory Deficits
• Memory Disorders
• Mood Change
• Physical Activity

Intervention

Behavioral:
• Therapy by Dance and Movement
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.
• Tai Chi
Tai Chi is based on somatic approach. Participants will attend sessions twice a week (90 minutes each) for the duration of three months.

Locations

Country	Name	City	State
Czechia	Faculty Hospital Vinohrady	Prague
Czechia	Faculty of Physical Education and Sport	Prague

Sponsors (3)

Lead Sponsor	Collaborator
Charles University, Czech Republic	Faculty of Physical Education and Sport, University Hospital Vinohrady

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Irisin blood levels after 3 months of the intervention	Irisin levels measured from 9ml blood samples	baseline to 3 months
Primary	Difference in Irisin blood levels between the arms at 3 months	Irisin levels measured from 9ml blood samples	3 months
Secondary	Change in brain derived neurotrophic factor (BDNF) levels at 3 months	BDNF measured from a 9ml blood samples.	baseline to 3 months
Secondary	Difference in brain derived neurotrophic factor (BDNF) levels at 3 months between the arms	BDNF measured from a 9ml blood samples.	3 months
Secondary	Change from baseline cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 3 months better outcome	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
Secondary	Difference in cognitive function in the Amnesia Light and Brief Assessment (ALBA) between the arms at 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
Secondary	Change from baseline cognitive function in Semantic word recollection (category: animals, 1 min) at 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
Secondary	Difference in cognitive function in Semantic word recollection (category: animals, 1 min) between the arms at 3 months	Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome	3 months
Secondary	Change in cognitive function in Semantic word recollection (category: letters, 1 min) at 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
Secondary	Difference in cognitive function in Semantic word recollection (category: letters, 1 min) at 3 months between the arms	Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome	3 months
Secondary	Change from baseline cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 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	baseline to 3 months
Secondary	Difference in cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 3 months between the arms	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
Secondary	Change in baseline cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 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	baseline to 3 months
Secondary	Difference in cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 3 months between the arms	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
Secondary	Change in baseline cognitive function in Trail Making Test (TMT), Parts A & B at 3 months	The TMT is a validated measure of cognitive function, the time upon completion is measured	baseline to 3 months
Secondary	Difference in cognitive function in Trail Making Test (TMT), Parts A & B at 3 months between the arms	The TMT is a validated measure of cognitive function, the time upon completion is measured	3 months
Secondary	Change in the Clock Drawing Test at 3 months	A validated measure where participant is asked to draw a clock face with the time 23:20	baseline to 3 months
Secondary	Difference in the Clock Drawing Test at 3 months between the arms	A validated measure where participant is asked to draw a clock face with the time 23:20	3 months
Secondary	Change in Line Picture Production test at 3 months	Participant is asked to produce as many as possible pictures consisting from 4 straight lines in 1 minute.	baseline to 3 months
Secondary	Difference in Line Picture Production test at 3 months between the arms	Participant is asked to produce as many as possible pictures consisting from 4 straight lines in 1 minute.	3 months
Secondary	Change in Picture Naming and Immediate Recall test (PICNIR) at 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
Secondary	Difference in Picture Naming and Immediate Recall test (PICNIR) at 3 months between the arms	Cognitive measure where participants first write down names of 20 pictures and then are asked to recall these names within 1 minute.	3 months
Secondary	Change in baseline mood in Geriatric Depression Scale at 3 months.	A self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome.	baseline to 3 months
Secondary	Difference in mood in Geriatric Depression Scale at 3 months.	A self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome.	3 months
Secondary	Change from baseline self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 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	baseline to 3 months
Secondary	Difference in self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 3 months between the arms	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
Secondary	Change in Sarcopenia at 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
Secondary	Difference in Sarcopenia at 3 months between the arms	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
Secondary	Change in knee extensor isometric strength and static fatigue at 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
Secondary	Difference in knee extensor isometric strength and static fatigue at 3 months between the arms	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
Secondary	Change in short physical performance battery (SPPB) at 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
Secondary	Difference in short physical performance battery (SPPB) at 3 months between the arms	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
Secondary	Change in Body Composition at 3 months	Body composition by a bioelectrical impedance analysis (BIA).	baseline to 3 months
Secondary	Difference in Body Composition at 3 months between the arms	Body composition by a bioelectrical impedance analysis (BIA).	3 months