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Effects of Group Music Therapy Interventions on Alzheimer's Disease Patients: a Three-arm Randomized Controlled Blind Study.

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Actice music therapy
Watching nature videos
Passive music therapy
Sponsored by
Universidad Católica San Antonio de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's disease, cognition., behaviour, function, motor function, active music therapy, passive music therapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Nursing-home dwelling
  • Diagnosis of probable Alzheimer's disease
  • Mild or moderate stage (Clinical Classification of the Dementia)

Exclusion Criteria:

  • Aphasia
  • Hearing impairment that may affect participation in the activities.

Sites / Locations

  • UCMurcia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

active music therapy

passive music therapy

control

Arm Description

Each 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.

The 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.

Patients were watching nature videos for the same duration than the interventions. A therapist was with them facilitating the activity.

Outcomes

Primary Outcome Measures

Mini Examination of the Mental State
Cognitive status. Range 0-30. Higher scores indicate better cognition
Neuropsychiatric Inventory
Behavioural disorders. Range 0-144. Higher scores indicate greater behavioural problems
Geriatric depression scale
Mood status. Range 0-15. Higher scores indicate worse mood status
Barthel index
Functional status. Range 0-100.Higher scores indicate worse functional status
Tinneti scale.Higher scores indicate better motor function
Motor function

Secondary Outcome Measures

Full Information

First Posted
February 12, 2021
Last Updated
February 17, 2021
Sponsor
Universidad Católica San Antonio de Murcia
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1. Study Identification

Unique Protocol Identification Number
NCT04761497
Brief Title
Effects of Group Music Therapy Interventions on Alzheimer's Disease Patients: a Three-arm Randomized Controlled Blind Study.
Official Title
Effects of Group Music Therapy Interventions on Alzheimer's Disease Patients: a Three-arm Randomized Controlled Blind Study.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 12, 2018 (Actual)
Primary Completion Date
December 19, 2018 (Actual)
Study Completion Date
January 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Católica San Antonio de Murcia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
Ninety AD patients from six nursing homes participated in the study. Nursing homes were randomly and blindly assigned to receive for three months either active music intervention, passive music listening or usual care. Effects on cognition, behaviour, daily living activities and motor function were assessed after the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's disease, cognition., behaviour, function, motor function, active music therapy, passive music therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active music therapy
Arm Type
Experimental
Arm Description
Each 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.
Arm Title
passive music therapy
Arm Type
Experimental
Arm Description
The 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.
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
Patients were watching nature videos for the same duration than the interventions. A therapist was with them facilitating the activity.
Intervention Type
Other
Intervention Name(s)
Actice music therapy
Intervention Description
active music therapy sessions for three months
Intervention Type
Other
Intervention Name(s)
Watching nature videos
Intervention Description
nature videos sessions for three months
Intervention Type
Other
Intervention Name(s)
Passive music therapy
Intervention Description
passive music therapy for three months
Primary Outcome Measure Information:
Title
Mini Examination of the Mental State
Description
Cognitive status. Range 0-30. Higher scores indicate better cognition
Time Frame
0-3 months
Title
Neuropsychiatric Inventory
Description
Behavioural disorders. Range 0-144. Higher scores indicate greater behavioural problems
Time Frame
0-3 months
Title
Geriatric depression scale
Description
Mood status. Range 0-15. Higher scores indicate worse mood status
Time Frame
0-3 months
Title
Barthel index
Description
Functional status. Range 0-100.Higher scores indicate worse functional status
Time Frame
0-3 months
Title
Tinneti scale.Higher scores indicate better motor function
Description
Motor function
Time Frame
0-3 months. Range 0-28

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Nursing-home dwelling Diagnosis of probable Alzheimer's disease Mild or moderate stage (Clinical Classification of the Dementia) Exclusion Criteria: Aphasia Hearing impairment that may affect participation in the activities.
Facility Information:
Facility Name
UCMurcia
City
Murcia
ZIP/Postal Code
30107
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Group Music Therapy Interventions on Alzheimer's Disease Patients: a Three-arm Randomized Controlled Blind Study.

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