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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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

hpolanska@ftvs.cuni.cz

Czechia2 sites, 2 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

    Recruiting

Other trials in Czechia

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.

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 groups in NCT05363228
Study groupRoleWhat they receive
Therapy by Dance and MovementExperimentalParticipants 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 TherapyNo interventionParticipants assigned to this arm take part in no particular activity for the three months.
Movement Therapy by Tai ChiExperimentalParticipants 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 ChiNo interventionParticipants 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.

  1. Change in Irisin blood levels after 3 months of the intervention

    Irisin levels measured from 9ml blood samples

    Measured: baseline to 3 months

  2. Difference in Irisin blood levels between the arms at 3 months

    Irisin levels measured from 9ml blood samples

    Measured: 3 months

Secondary outcomes (32)
  1. Change in brain derived neurotrophic factor (BDNF) levels at 3 months

    BDNF measured from a 9ml blood samples.

    Measured: baseline to 3 months

  2. Difference in brain derived neurotrophic factor (BDNF) levels at 3 months between the arms

    BDNF measured from a 9ml blood samples.

    Measured: 3 months

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. Change in Body Composition at 3 months

    Body composition by a bioelectrical impedance analysis (BIA).

    Measured: baseline to 3 months

  32. 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.

  1. First posted5 May 2022
  2. Study start1 Aug 2021
  3. Primary completion30 Jan 2023 (estimated)
  4. Study completion30 Jan 2023 (estimated)

Resources

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)
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

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; AzTrials last refreshed its copy on 7 Nov 2026.

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