Ignite Creation Date:
2024-05-06 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05363228
Status:
UNKNOWN
Last Update Posted:
2022-05-05
First Post:
2022-05-03
Brief Title:
The Effect of Tai Chi and Therapy by Dance and Movement on Blood Irisin Levels in Older Adults Over 65 Years of Age
Sponsor:
Charles University Czech Republic
Organization:
Charles University Czech Republic
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Alzheimers 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 httpswwwalzcoukresearchstatistics Alzheimers 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
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 Alzheimers 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 httpswwwalzcoukresearchstatistics Alzheimers 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
Detailed 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 Alzheimers 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 httpswwwalzcoukresearchstatistics Alzheimers 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None