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

3 de mayo de 2022 actualizado por: Hana Polanska, Charles University, Czech Republic

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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

90

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

      • Prague, Chequia
        • Reclutamiento
        • Faculty Hospital Vinohrady
        • Contacto:
      • Prague, Chequia
        • Reclutamiento
        • Faculty of Physical Education and Sport
        • Contacto:
          • Michal Steffl, doc.
          • Número de teléfono: +42O778701882
          • Correo electrónico: steffl@ftvs.cuni.cz

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

65 años a 80 años (Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Therapy by Dance and Movement
Participants assigned to this part take part in Dance Movement Therapy twice a week (90 minutes each) for the duration of three months.
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.
Sin intervención: Control to Dance Movement Therapy
Participants assigned to this arm take part in no particular activity for the three months.
Experimental: Movement Therapy by Tai Chi
Participants assigned to this part take part inTai Chi class twice a week (90 minutes each) for the duration of three months.
Tai Chi is based on somatic approach. Participants will attend sessions twice a week (90 minutes each) for the duration of three months.
Sin intervención: Control to Tai Chi
Participants assigned to this arm take part in no particular activity for the three months.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Irisin blood levels after 3 months of the intervention
Periodo de tiempo: baseline to 3 months
Irisin levels measured from 9ml blood samples
baseline to 3 months
Difference in Irisin blood levels between the arms at 3 months
Periodo de tiempo: 3 months
Irisin levels measured from 9ml blood samples
3 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in brain derived neurotrophic factor (BDNF) levels at 3 months
Periodo de tiempo: baseline to 3 months
BDNF measured from a 9ml blood samples.
baseline to 3 months
Difference in brain derived neurotrophic factor (BDNF) levels at 3 months between the arms
Periodo de tiempo: 3 months
BDNF measured from a 9ml blood samples.
3 months
Change from baseline cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 3 months better outcome
Periodo de tiempo: baseline to 3 months
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
Difference in cognitive function in the Amnesia Light and Brief Assessment (ALBA) between the arms at 3 months
Periodo de tiempo: 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
Cambio desde la función cognitiva inicial en el recuerdo semántico de palabras (categoría: animales, 1 min) a los 3 meses
Periodo de tiempo: línea de base a 3 meses
El recuerdo semántico de palabras es una medida de la función cognitiva, los resultados varían de 0 a 40 aproximadamente, más puntos significan un mejor resultado
línea de base a 3 meses
Difference in cognitive function in Semantic word recollection (category: animals, 1 min) between the arms at 3 months
Periodo de tiempo: 3 months
Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome
3 months
Change in cognitive function in Semantic word recollection (category: letters, 1 min) at 3 months
Periodo de tiempo: baseline to 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
Difference in cognitive function in Semantic word recollection (category: letters, 1 min) at 3 months between the arms
Periodo de tiempo: 3 months
Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome
3 months
Cambio desde la función cognitiva inicial en la prueba de aprendizaje verbal auditivo de Rey (RAVLT) a los 3 meses
Periodo de tiempo: línea de base a 3 meses
RAVLT es una medida validada de la función cognitiva, tiene 8 subescalas, cada una de las cuales va de 0 a 15, medidas en puntajes brutos que están conectados a la norma de población dependiente de la edad.
línea de base a 3 meses
Difference in cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 3 months between the arms
Periodo de tiempo: 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
3 months
Cambio en la función cognitiva inicial en la escala de inteligencia para adultos de Wechsler, tercera edición (WAIS III) - subprueba de "Símbolos" a los 3 meses
Periodo de tiempo: línea de base a 3 meses
La subprueba "Símbolos" de WAIS III es una medida validada de la función cognitiva, la escala de puntos varía de 0 a 133 y un mayor logro de puntos indica un mejor resultado
línea de base a 3 meses
Difference in cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 3 months between the arms
Periodo de tiempo: 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
3 months
Cambio en la función cognitiva inicial en el Trail Making Test (TMT), Partes A y B a los 3 meses
Periodo de tiempo: línea de base a 3 meses
El TMT es una medida validada de la función cognitiva, se mide el tiempo después de completarlo
línea de base a 3 meses
Difference in cognitive function in Trail Making Test (TMT), Parts A & B at 3 months between the arms
Periodo de tiempo: 3 months
The TMT is a validated measure of cognitive function, the time upon completion is measured
3 months
Change in the Clock Drawing Test at 3 months
Periodo de tiempo: baseline to 3 months
A validated measure where participant is asked to draw a clock face with the time 23:20
baseline to 3 months
Difference in the Clock Drawing Test at 3 months between the arms
Periodo de tiempo: 3 months
A validated measure where participant is asked to draw a clock face with the time 23:20
3 months
Change in Line Picture Production test at 3 months
Periodo de tiempo: baseline to 3 months
Participant is asked to produce as many as possible pictures consisting from 4 straight lines in 1 minute.
baseline to 3 months
Difference in Line Picture Production test at 3 months between the arms
Periodo de tiempo: 3 months
Participant is asked to produce as many as possible pictures consisting from 4 straight lines in 1 minute.
3 months
Change in Picture Naming and Immediate Recall test (PICNIR) at 3 months
Periodo de tiempo: Baseline to 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
Difference in Picture Naming and Immediate Recall test (PICNIR) at 3 months between the arms
Periodo de tiempo: 3 months
Cognitive measure where participants first write down names of 20 pictures and then are asked to recall these names within 1 minute.
3 months
Change in baseline mood in Geriatric Depression Scale at 3 months.
Periodo de tiempo: baseline to 3 months
A self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome.
baseline to 3 months
Difference in mood in Geriatric Depression Scale at 3 months.
Periodo de tiempo: 3 months
A self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome.
3 months
Cambio respecto a la autosuficiencia basal autoinformada en el Cuestionario de estado funcional (abreviatura en idioma original: subjetivo FAQ-CZ) a los 3 meses
Periodo de tiempo: línea de base a 3 meses
FAQ-CZ es una medida de autoinforme de la autosuficiencia, se mide en una escala de 0 a 30 con un mayor logro de puntos que indica un peor resultado
línea de base a 3 meses
Difference in self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 3 months between the arms
Periodo de tiempo: 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
3 months
Change in Sarcopenia at 3 months
Periodo de tiempo: baseline to 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
Difference in Sarcopenia at 3 months between the arms
Periodo de tiempo: 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.
3 months
Change in knee extensor isometric strength and static fatigue at 3 months
Periodo de tiempo: baseline to 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
Difference in knee extensor isometric strength and static fatigue at 3 months between the arms
Periodo de tiempo: 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.
3 months
Change in short physical performance battery (SPPB) at 3 months
Periodo de tiempo: baseline to 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
Difference in short physical performance battery (SPPB) at 3 months between the arms
Periodo de tiempo: 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.
3 months
Change in Body Composition at 3 months
Periodo de tiempo: baseline to 3 months
Body composition by a bioelectrical impedance analysis (BIA).
baseline to 3 months
Difference in Body Composition at 3 months between the arms
Periodo de tiempo: 3 months
Body composition by a bioelectrical impedance analysis (BIA).
3 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de agosto de 2021

Finalización primaria (Anticipado)

30 de enero de 2023

Finalización del estudio (Anticipado)

30 de enero de 2023

Fechas de registro del estudio

Enviado por primera vez

3 de mayo de 2022

Primero enviado que cumplió con los criterios de control de calidad

3 de mayo de 2022

Publicado por primera vez (Actual)

5 de mayo de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de mayo de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

3 de mayo de 2022

Última verificación

1 de mayo de 2022

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

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INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Therapy by Dance and Movement

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