Memory DeficitsNCT05363228
The Effect of Tai Chi and Therapy by Dance and Movement on Blood Irisin Levels in Older Adults Over 65 Years of Age.
A study testing Therapy by Dance and Movement and Tai Chi in people with Memory Deficits and Aging, run by Charles University, Czech Republic at 2 sites in Czechia.
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. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Memory Deficits, Aging, Cognitive Impairment
- What is being tested?
- Therapy by Dance and Movement and Tai Chi
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesCzechia
- Study dates
- 1 Aug 2021to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Hana Polanska contact
Czechia2 sites, 2 recruiting
- Recruiting
Faculty Hospital Vinohrady
Prague
Ales Bartos, Prof, MuDr., Ph.D., ales.bartos@fnkv.cz
- Recruiting
Faculty of Physical Education and Sport
Prague
Michal Steffl, doc., +42O778701882, steffl@ftvs.cuni.cz
About this study
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.
Read the 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 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.
- Conditions
- Memory Deficits, Aging, Cognitive Impairment, Physical Activity, Mood Change
- Being tested
- Therapy by Dance and Movement, Tai Chi
- Keywords
- Irisin, BDNF, Cognition, Aging, Therapy by Dance and Movement, Tai Chi
- Medical subject headings
- Memory Disorders, Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapy by Dance and MovementBehavioural
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 ChiBehavioural
Tai Chi is based on somatic approach. Participants will attend sessions twice a week (90 minutes each) for the duration of three months.
| Study group | Role | What they receive |
|---|---|---|
| Therapy by Dance and Movement | Experimental | Participants assigned to this part take part in Dance Movement Therapy twice a week (90 minutes each) for the duration of three months. Receives: Behavioral: Therapy by Dance and Movement |
| Control to Dance Movement Therapy | No intervention | Participants assigned to this arm take part in no particular activity for the three months. |
| Movement Therapy by Tai Chi | Experimental | Participants assigned to this part take part inTai Chi class twice a week (90 minutes each) for the duration of three months. Receives: Behavioral: Tai Chi |
| Control to Tai Chi | No intervention | Participants assigned to this arm take part in no particular activity for the three months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Irisin blood levels after 3 months of the intervention
Irisin levels measured from 9ml blood samples
Measured: baseline to 3 months
Difference in Irisin blood levels between the arms at 3 months
Irisin levels measured from 9ml blood samples
Measured: 3 months
Secondary outcomes (32)
Change in brain derived neurotrophic factor (BDNF) levels at 3 months
BDNF measured from a 9ml blood samples.
Measured: baseline to 3 months
Difference in brain derived neurotrophic factor (BDNF) levels at 3 months between the arms
BDNF measured from a 9ml blood samples.
Measured: 3 months
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
Measured: baseline to 3 months
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
Measured: 3 months
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
Measured: baseline to 3 months
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
Measured: 3 months
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
Measured: baseline to 3 months
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
Measured: 3 months
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
Measured: baseline to 3 months
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
Measured: 3 months
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
Measured: baseline to 3 months
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
Measured: 3 months
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
Measured: baseline to 3 months
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
Measured: 3 months
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
Measured: baseline to 3 months
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
Measured: 3 months
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.
Measured: baseline to 3 months
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.
Measured: 3 months
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
Measured: Baseline to 3 months
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.
Measured: 3 months
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.
Measured: baseline to 3 months
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.
Measured: 3 months
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
Measured: baseline to 3 months
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
Measured: 3 months
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.
Measured: baseline to 3 months
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.
Measured: 3 months
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.
Measured: baseline to 3 months
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.
Measured: 3 months
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.
Measured: baseline to 3 months
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.
Measured: 3 months
Change in Body Composition at 3 months
Body composition by a bioelectrical impedance analysis (BIA).
Measured: baseline to 3 months
Difference in Body Composition at 3 months between the arms
Body composition by a bioelectrical impedance analysis (BIA).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start1 Aug 2021
- Primary completion30 Jan 2023 (estimated)
- Study completion30 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Memory DeficitsStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Vinohrady, Faculty of Physical Education and Sport
- Responsible party
- Principal investigator, Hana Polanska, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363228
- Sponsor's protocol ID
- GAUK/268321
- Status last verified
- May 2022
- First submitted
- 3 May 2022
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hola V, Polanska H, Jandova T, Jaklova Dytrtova J, Weinerova J, Steffl M, Kramperova V, Dadova K, Durkalec-Michalski K, Bartos A. The Effect of Two Somatic-Based Practices Dance and Martial Arts on Irisin, BDNF Levels and Cognitive and Physical Fitness in Older Adults: A Randomized Control Trial. Clin Interv Aging. 2024 Nov 6;19:1829-1842. doi: 10.2147/CIA.S482479. eCollection 2024.
PubMed 39525874
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05363228
- Acronym / sponsor ID
- GAUK/268321
- Conditions
- Memory Deficits, Aging, Cognitive Impairment, Physical Activity, Mood Change
- Keywords
- Irisin, BDNF, Cognition, Aging, Therapy by Dance and Movement, Tai Chi
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- University Hospital Vinohrady, Faculty of Physical Education and Sport
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Jan 2023 (estimated)
- Study completion
- 30 Jan 2023 (estimated)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Therapy by Dance and Movement | Experimental | Behavioral: Therapy by Dance and MovementParticipants assigned to this part take part in Dance Movement Therapy twice a week (90 minutes each) for the duration of three months. |
| Control to Dance Movement Therapy | No intervention | –Participants assigned to this arm take part in no particular activity for the three months. |
| Movement Therapy by Tai Chi | Experimental | Behavioral: Tai ChiParticipants assigned to this part take part inTai Chi class twice a week (90 minutes each) for the duration of three months. |
| Control to Tai Chi | No intervention | –Participants assigned to this arm take part in no particular activity for the three months. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapy by Dance and MovementTherapy 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. | Behavioural | Therapy by Dance and Movement |
| Tai ChiTai Chi is based on somatic approach. Participants will attend sessions twice a week (90 minutes each) for the duration of three months. | Behavioural | Movement Therapy by Tai Chi |
Primary outcome
Change in Irisin blood levels after 3 months of the intervention
Time frame: baseline to 3 months
Irisin levels measured from 9ml blood samples
Difference in Irisin blood levels between the arms at 3 months
Time frame: 3 months
Irisin levels measured from 9ml blood samples
32 secondary outcomes
Change in brain derived neurotrophic factor (BDNF) levels at 3 months
Time frame: baseline to 3 months
Difference in brain derived neurotrophic factor (BDNF) levels at 3 months between the arms
Time frame: 3 months
Change from baseline cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 3 months better outcome
Time frame: baseline to 3 months
Difference in cognitive function in the Amnesia Light and Brief Assessment (ALBA) between the arms at 3 months
Time frame: 3 months
Change from baseline cognitive function in Semantic word recollection (category: animals, 1 min) at 3 months
Time frame: baseline to 3 months
Difference in cognitive function in Semantic word recollection (category: animals, 1 min) between the arms at 3 months
Time frame: 3 months
Change in cognitive function in Semantic word recollection (category: letters, 1 min) at 3 months
Time frame: baseline to 3 months
Difference in cognitive function in Semantic word recollection (category: letters, 1 min) at 3 months between the arms
Time frame: 3 months
Change from baseline cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 3 months
Time frame: baseline to 3 months
Difference in cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 3 months between the arms
Time frame: 3 months
Change in baseline cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 3 months
Time frame: baseline to 3 months
Difference in cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 3 months between the arms
Time frame: 3 months
Change in baseline cognitive function in Trail Making Test (TMT), Parts A & B at 3 months
Time frame: baseline to 3 months
Difference in cognitive function in Trail Making Test (TMT), Parts A & B at 3 months between the arms
Time frame: 3 months
Change in the Clock Drawing Test at 3 months
Time frame: baseline to 3 months
Difference in the Clock Drawing Test at 3 months between the arms
Time frame: 3 months
Change in Line Picture Production test at 3 months
Time frame: baseline to 3 months
Difference in Line Picture Production test at 3 months between the arms
Time frame: 3 months
Change in Picture Naming and Immediate Recall test (PICNIR) at 3 months
Time frame: Baseline to 3 months
Difference in Picture Naming and Immediate Recall test (PICNIR) at 3 months between the arms
Time frame: 3 months
Change in baseline mood in Geriatric Depression Scale at 3 months.
Time frame: baseline to 3 months
Difference in mood in Geriatric Depression Scale at 3 months.
Time frame: 3 months
Change from baseline self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 3 months
Time frame: baseline to 3 months
Difference in self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 3 months between the arms
Time frame: 3 months
Change in Sarcopenia at 3 months
Time frame: baseline to 3 months
Difference in Sarcopenia at 3 months between the arms
Time frame: 3 months
Change in knee extensor isometric strength and static fatigue at 3 months
Time frame: baseline to 3 months
Difference in knee extensor isometric strength and static fatigue at 3 months between the arms
Time frame: 3 months
Change in short physical performance battery (SPPB) at 3 months
Time frame: baseline to 3 months
Difference in short physical performance battery (SPPB) at 3 months between the arms
Time frame: 3 months
Change in Body Composition at 3 months
Time frame: baseline to 3 months
Difference in Body Composition at 3 months between the arms
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Derived from this study: PubMed 39525874Hola V, Polanska H, Jandova T, Jaklova Dytrtova J, Weinerova J, Steffl M, Kramperova V, Dadova K, Durkalec-Michalski K, Bartos A. The Effect of Two Somatic-Based Practices Dance and Martial Arts on Irisin, BDNF Levels and Cognitive and Physical Fitness in Older Adults: A Randomized Control Trial. Clin Interv Aging. 2024 Nov 6;19:1829-1842. doi: 10.2147/CIA.S482479. eCollection 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hana Polanska contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapy by Dance and Movement and Tai Chi in people with Memory Deficits and Aging, run by Charles University, Czech Republic at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hana Polanska (hpolanska@ftvs.cuni.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Irisin blood levels after 3 months of the intervention (time frame: baseline to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05363228, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.