Effects of Group Music Therapy Interventions on Alzheimer's Disease Patients: a Three-arm Randomized Controlled Blind Study.
1 other identifier
interventional
90
1 country
1
Brief Summary
The purpose of this study is to determine what type of music therapy (active versus passive) approach has higher effects on clinical symptoms in advanced Alzheimer's disease patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 7, 2019
CompletedFirst Submitted
Initial submission to the registry
February 12, 2021
CompletedFirst Posted
Study publicly available on registry
February 21, 2021
CompletedFebruary 21, 2021
February 1, 2021
3 months
February 12, 2021
February 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Mini Examination of the Mental State
Cognitive status. Range 0-30. Higher scores indicate better cognition
0-3 months
Neuropsychiatric Inventory
Behavioural disorders. Range 0-144. Higher scores indicate greater behavioural problems
0-3 months
Geriatric depression scale
Mood status. Range 0-15. Higher scores indicate worse mood status
0-3 months
Barthel index
Functional status. Range 0-100.Higher scores indicate worse functional status
0-3 months
Tinneti scale.Higher scores indicate better motor function
Motor function
0-3 months. Range 0-28
Study Arms (3)
active music therapy
EXPERIMENTALEach session consisted of: song of welcome (patients had to greet and introduce themselves), rhythmic exercise (three songs were used; therapist and patients kept rhythm by clapping their hands), dance exercises (three songs were used; patients should make free body movements in response to music), game of recognition of songs and interpreters (four songs were used) and song of goodbye.
passive music therapy
EXPERIMENTALThe therapist and the patients were seat listening to the music recorded in a CD. The therapist told patients which the name and the interpreter of each song of the list.
control
PLACEBO COMPARATORPatients were watching nature videos for the same duration than the interventions. A therapist was with them facilitating the activity.
Interventions
Eligibility Criteria
You may qualify if:
- Nursing-home dwelling
- Diagnosis of probable Alzheimer's disease
- Mild or moderate stage (Clinical Classification of the Dementia)
You may not qualify if:
- Aphasia
- Hearing impairment that may affect participation in the activities.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCMurcia
Murcia, 30107, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Profª Dr María Gómez-Gallego
Study Record Dates
First Submitted
February 12, 2021
First Posted
February 21, 2021
Study Start
September 12, 2018
Primary Completion
December 19, 2018
Study Completion
January 7, 2019
Last Updated
February 21, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share