NCT05363228

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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

May 5, 2022

Status Verified

May 1, 2022

Enrollment Period

1.5 years

First QC Date

May 3, 2022

Last Update Submit

May 3, 2022

Conditions

Keywords

IrisinBDNFCognitionAgingTherapy by Dance and MovementTai Chi

Outcome Measures

Primary Outcomes (2)

  • Change in Irisin blood levels after 3 months of the intervention

    Irisin levels measured from 9ml blood samples

    baseline to 3 months

  • Difference in Irisin blood levels between the arms at 3 months

    Irisin levels measured from 9ml blood samples

    3 months

Secondary Outcomes (32)

  • Change in brain derived neurotrophic factor (BDNF) levels at 3 months

    baseline to 3 months

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

    3 months

  • Change from baseline cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 3 months better outcome

    baseline to 3 months

  • Difference in cognitive function in the Amnesia Light and Brief Assessment (ALBA) between the arms at 3 months

    3 months

  • Change from baseline cognitive function in Semantic word recollection (category: animals, 1 min) at 3 months

    baseline to 3 months

  • +27 more secondary outcomes

Study Arms (4)

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.

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.

Behavioral: Tai Chi

Control to Tai Chi

NO INTERVENTION

Participants assigned to this arm take part in no particular activity for the three months.

Interventions

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.

Therapy by Dance and Movement
Tai ChiBEHAVIORAL

Tai Chi is based on somatic approach. Participants will attend sessions twice a week (90 minutes each) for the duration of three months.

Movement Therapy by Tai Chi

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty Hospital Vinohrady

Prague, Czechia

RECRUITING

Faculty of Physical Education and Sport

Prague, Czechia

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Memory DisordersCognitive DysfunctionMotor Activity

Interventions

MovementTai Ji

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Physiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaMind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Central Study Contacts

Hana Polanska

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

May 3, 2022

First Posted

May 5, 2022

Study Start

August 1, 2021

Primary Completion

January 30, 2023

Study Completion

January 30, 2023

Last Updated

May 5, 2022

Record last verified: 2022-05

Locations