Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06378372
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-04-18
Brief Title:
How Does Pianistic Musical Training Influence the Development of Alzheimers Disease
Sponsor:
David Franco Castellanos
Organization:
Universidad de León
Study Overview
Official Title:
Effect of Musical Intervention Based on Piano Learning on Alzheimers Patients in León España
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn about and describe how pianistic training influences the development of Alzheimers disease
The key question is Can pianistic practice influence the development of Alzheimers disease
Participants will receive piano lessons for 4 weeks 20 sessions and we will evaluate the evolution of the different parameters described by the tests carried out
The key question is Can pianistic practice influence the development of Alzheimers disease
Participants will receive piano lessons for 4 weeks 20 sessions and we will evaluate the evolution of the different parameters described by the tests carried out
Detailed Description:
Alzheimers disease AD is a chronic neurodegenerative disease that affects different areas of the brain causing progressive changes in behavior memory loss decreased personal autonomy and various cognitive alterations Masters et al NINDS 2019 Alzheimers Association 2020
According to the World Health Organization WHO currently around 50 million people suffer from some type of diagnosed dementia of which 60-70 of them report some type or degree of EA Alzheimers Association 2020 WHO 2020
Not only is AD considered a worrying pathology today but the forecast for medium and long term envisions a severe evolution that will reach 75 million cases in 2030 and 132 million in 2050 Scheltens et al 2016 MSCBS 2019 Specifically in Spain there are more than 700000 patients currently diagnosed and the forecast is that this number of people affected by AD will double in 2050 MSCBS 2019
Since at the beginning of the s XX the characteristics of AD were described for the first time Mauer K 2006 scientific research has been in its beginnings aimed at alleviating the disease since a pharmacological point of view with modestly effective results López 2015 and effects secondary sometimes unwanted It therefore seems necessary to address the research and treatment of this disease from a non-pharmacological prism in which music has shown a high degree of efficiency with no adverse effects
It is at this point that other alternative therapies such as music therapy take center stage providing notable evidence of the brain activation that occurs especially when the patient receives sound stimuli Peretz 2005
The value of music is evident in the numerous cases of musicians pianists violinists who after a diagnosis of AD begin to experience cognitive and physical deterioration expected however this degenerative process does not seem to affect their motor or intellectual to play his instrument even when the disease is in its most severe stage Pladdy 2011
Thus arises the need to go deeper and discover how music interferes in the process neurodegenerative caused by AD and how it can partner with the patient to potentially improve your quality of life strengthen your cognitive reserve become a useful routine and viable to implement active aging and ultimately accompany the patient during evolution of this pathology and why not when the time comes to reverse its advance
The most common interventions that focus on music as a vehicle to treat AD are aimed at mitigating stress reducing anxiety and controlling agitation through listening dancing or singing Baird 2009 However there are no studies that describe the influence that has to learn to play a musical instrument in the case of this doctoral thesis the piano in the evolution of AD
The piano is an instrument capable of mobilizing sight hearing touch gross and fine motor skills perception and emotion activating and making multiple parts of the brain interact Paxinos 2004 hippocampus cerebral cortex which judging by the latest studies are related to the detection evolution and treatment of AD
Hypothesis
- A therapy based on teaching patients with AD to play the piano may be beneficial for increase your Cognitive Reserve Capacity and improve your Quality of Life
In this sense it has been shown that complex mental activity throughout the life cycle can work as a neuroprotective factor in AD Valenzuela 2006
General objective
- Analyze the effects of a musical intervention based on piano learning on Alzheimers patients in León
Specific objectives
Generate a specific didactic program adapted to Alzheimers patients based on in acquiring piano skills
Involve the members under study in a prolonged musical experience in time 4 weeks and value its significance from a therapeutic point of view
Evaluate the evolution of the acquisition of sensory and musical skills in the course of the intervention
Carry out a longitudinal-correlational study of the results obtained pre-post intervention Spss
Make an evaluation of the didactic programming and the quality and suitability of the intervention at the end of it to where appropriate modify and reorient the aspects susceptible to improvement
Methodology
The preparation of this study will be structured around three phases A first phase of documentation on the state of the matter and preparation of the teaching materials that will form part of the resources necessary to carry out the therapeutic intervention A second phase that will consist of the intervention itself as well as the collection of the data provided by the control of the different variables subject to study and finally a third phase consisting of the evaluation of the data collected as well as a critical assessment of the pedagogical procedure and in If applicable a proposal for an improvement plan for this intervention will be made
The general methodology of the musical intervention will be an active participatory inclusive methodology and integrative based on project-based learning It will take into account at all times the uniqueness of each patient therefore applying personalized attention In it they will be used musical and extra-musical resources as formative elements also valuing the Free improvisation as an artistic formula and musical and emotional expression
The didactic programming will be aimed at developing motor control developing the connection Be careful listen and will also try to develop the capacity for self-criticism and frustration management anxiety and emotional control
The specific methodology of each therapy session will be defined in each of the units that they will make up the didactic programming prepared to carry out the intervention Having in keep in mind that each session will last 30 minutes the general methodological dynamic will revolve around this temporary organization
Activation 5Making contact with himspace - teacher - instrument Development 20 Pedagogical intervention Relaxation 5Back to the calm
Tests and variables
Age sex socio-economic-cultural profile nutritional status motor status and other clinical data ofpatient interest tension glucose
Cognitive state Minimal clock cancellation and Ways
Global
Domains Memory procedural and declarative Language Visuospatial
Attention
Visoconstructive Executive abilities Behavioral status medication Typology of dementia inclusion and exclusion criteria in the study Degree of AD Mild moderate severe very severe State of global deterioration
Functional tests RDRS-2 Rapid Disability Assessment Scale
Cognitive evaluation tests MOCA WAIS-IV digits IST ZAZZO Trail Making Test Clock Fluency Verbalcategorical
Neuropsychiatric evaluation test
Behavioral disorders BEHAVE-AD Sclan 1996
Frequency and severity of symptoms Neuropsychiatric Inventory NPI Cummings 1994
NPI-Q gravity part
NPI-Q caregiver stress
Evaluation of the severity of the disease CDS and GDR Scales
Evaluation of the caregivers burden Zarit test
MEDIA AND MATERIAL RESOURCES AVAILABLE
This Initial Research Plan will be presented to the management of ALZHEIMER LEON to make a joint assessment of the suitability and viability of the proposed intervention
Once approved its execution the subjects who will make up the sample on which it will be determined will be determined Will enhance the intervention A series of tests will be carried out to determine the characteristics of the itself and inclusionexclusion criteria will be set according to the needs of the study
Additionally there will be the departments of interest for the study Psychology psychiatry therapists social workers In addition this intervention project will be presented to different entities to achieve maximum economic human and institutional coverage In this sense some have been tested private and public institutions such as the Valverde de La Virgen School of Music through its City Council or JJMM-ULE all of them showing great interest in the study and valuing positively their participation in the research without limiting for the moment the role that each of them they would take in the process
To carry out the intervention it will be necessary to have a specialist pianist teacher with a solid musical and pedagogical training and with an additional approach to the particularities of the sample and dynamics of the didactic programming prepared for the study It will be very important and It is also necessary to have adequate financing to meet the expenses derived from the hiring and training of this professional and other unexpected expenses
At all times we will try to find appropriate synergies with other entities interested in this study to join forces that give economic viability and dissemination to the project and its results through agreements collaborations donations or contributions of any nature
According to the World Health Organization WHO currently around 50 million people suffer from some type of diagnosed dementia of which 60-70 of them report some type or degree of EA Alzheimers Association 2020 WHO 2020
Not only is AD considered a worrying pathology today but the forecast for medium and long term envisions a severe evolution that will reach 75 million cases in 2030 and 132 million in 2050 Scheltens et al 2016 MSCBS 2019 Specifically in Spain there are more than 700000 patients currently diagnosed and the forecast is that this number of people affected by AD will double in 2050 MSCBS 2019
Since at the beginning of the s XX the characteristics of AD were described for the first time Mauer K 2006 scientific research has been in its beginnings aimed at alleviating the disease since a pharmacological point of view with modestly effective results López 2015 and effects secondary sometimes unwanted It therefore seems necessary to address the research and treatment of this disease from a non-pharmacological prism in which music has shown a high degree of efficiency with no adverse effects
It is at this point that other alternative therapies such as music therapy take center stage providing notable evidence of the brain activation that occurs especially when the patient receives sound stimuli Peretz 2005
The value of music is evident in the numerous cases of musicians pianists violinists who after a diagnosis of AD begin to experience cognitive and physical deterioration expected however this degenerative process does not seem to affect their motor or intellectual to play his instrument even when the disease is in its most severe stage Pladdy 2011
Thus arises the need to go deeper and discover how music interferes in the process neurodegenerative caused by AD and how it can partner with the patient to potentially improve your quality of life strengthen your cognitive reserve become a useful routine and viable to implement active aging and ultimately accompany the patient during evolution of this pathology and why not when the time comes to reverse its advance
The most common interventions that focus on music as a vehicle to treat AD are aimed at mitigating stress reducing anxiety and controlling agitation through listening dancing or singing Baird 2009 However there are no studies that describe the influence that has to learn to play a musical instrument in the case of this doctoral thesis the piano in the evolution of AD
The piano is an instrument capable of mobilizing sight hearing touch gross and fine motor skills perception and emotion activating and making multiple parts of the brain interact Paxinos 2004 hippocampus cerebral cortex which judging by the latest studies are related to the detection evolution and treatment of AD
Hypothesis
- A therapy based on teaching patients with AD to play the piano may be beneficial for increase your Cognitive Reserve Capacity and improve your Quality of Life
In this sense it has been shown that complex mental activity throughout the life cycle can work as a neuroprotective factor in AD Valenzuela 2006
General objective
- Analyze the effects of a musical intervention based on piano learning on Alzheimers patients in León
Specific objectives
Generate a specific didactic program adapted to Alzheimers patients based on in acquiring piano skills
Involve the members under study in a prolonged musical experience in time 4 weeks and value its significance from a therapeutic point of view
Evaluate the evolution of the acquisition of sensory and musical skills in the course of the intervention
Carry out a longitudinal-correlational study of the results obtained pre-post intervention Spss
Make an evaluation of the didactic programming and the quality and suitability of the intervention at the end of it to where appropriate modify and reorient the aspects susceptible to improvement
Methodology
The preparation of this study will be structured around three phases A first phase of documentation on the state of the matter and preparation of the teaching materials that will form part of the resources necessary to carry out the therapeutic intervention A second phase that will consist of the intervention itself as well as the collection of the data provided by the control of the different variables subject to study and finally a third phase consisting of the evaluation of the data collected as well as a critical assessment of the pedagogical procedure and in If applicable a proposal for an improvement plan for this intervention will be made
The general methodology of the musical intervention will be an active participatory inclusive methodology and integrative based on project-based learning It will take into account at all times the uniqueness of each patient therefore applying personalized attention In it they will be used musical and extra-musical resources as formative elements also valuing the Free improvisation as an artistic formula and musical and emotional expression
The didactic programming will be aimed at developing motor control developing the connection Be careful listen and will also try to develop the capacity for self-criticism and frustration management anxiety and emotional control
The specific methodology of each therapy session will be defined in each of the units that they will make up the didactic programming prepared to carry out the intervention Having in keep in mind that each session will last 30 minutes the general methodological dynamic will revolve around this temporary organization
Activation 5Making contact with himspace - teacher - instrument Development 20 Pedagogical intervention Relaxation 5Back to the calm
Tests and variables
Age sex socio-economic-cultural profile nutritional status motor status and other clinical data ofpatient interest tension glucose
Cognitive state Minimal clock cancellation and Ways
Global
Domains Memory procedural and declarative Language Visuospatial
Attention
Visoconstructive Executive abilities Behavioral status medication Typology of dementia inclusion and exclusion criteria in the study Degree of AD Mild moderate severe very severe State of global deterioration
Functional tests RDRS-2 Rapid Disability Assessment Scale
Cognitive evaluation tests MOCA WAIS-IV digits IST ZAZZO Trail Making Test Clock Fluency Verbalcategorical
Neuropsychiatric evaluation test
Behavioral disorders BEHAVE-AD Sclan 1996
Frequency and severity of symptoms Neuropsychiatric Inventory NPI Cummings 1994
NPI-Q gravity part
NPI-Q caregiver stress
Evaluation of the severity of the disease CDS and GDR Scales
Evaluation of the caregivers burden Zarit test
MEDIA AND MATERIAL RESOURCES AVAILABLE
This Initial Research Plan will be presented to the management of ALZHEIMER LEON to make a joint assessment of the suitability and viability of the proposed intervention
Once approved its execution the subjects who will make up the sample on which it will be determined will be determined Will enhance the intervention A series of tests will be carried out to determine the characteristics of the itself and inclusionexclusion criteria will be set according to the needs of the study
Additionally there will be the departments of interest for the study Psychology psychiatry therapists social workers In addition this intervention project will be presented to different entities to achieve maximum economic human and institutional coverage In this sense some have been tested private and public institutions such as the Valverde de La Virgen School of Music through its City Council or JJMM-ULE all of them showing great interest in the study and valuing positively their participation in the research without limiting for the moment the role that each of them they would take in the process
To carry out the intervention it will be necessary to have a specialist pianist teacher with a solid musical and pedagogical training and with an additional approach to the particularities of the sample and dynamics of the didactic programming prepared for the study It will be very important and It is also necessary to have adequate financing to meet the expenses derived from the hiring and training of this professional and other unexpected expenses
At all times we will try to find appropriate synergies with other entities interested in this study to join forces that give economic viability and dissemination to the project and its results through agreements collaborations donations or contributions of any nature
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None