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

February 17, 2021 updated by: María Gómez-Gallego, Universidad Católica San Antonio de Murcia
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Murcia, Spain, 30107
        • UCMurcia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: active music therapy
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.
Other: Actice music therapy
active music therapy sessions for three months
Experimental: passive music therapy
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.
Other: Passive music therapy
passive music therapy for three months
Placebo Comparator: control
Patients were watching nature videos for the same duration than the interventions. A therapist was with them facilitating the activity.
Other: Watching nature videos
nature videos sessions for three months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mini Examination of the Mental State
Time Frame: 0-3 months
Cognitive status. Range 0-30. Higher scores indicate better cognition
0-3 months
Neuropsychiatric Inventory
Time Frame: 0-3 months
Behavioural disorders. Range 0-144. Higher scores indicate greater behavioural problems
0-3 months
Geriatric depression scale
Time Frame: 0-3 months
Mood status. Range 0-15. Higher scores indicate worse mood status
0-3 months
Barthel index
Time Frame: 0-3 months
Functional status. Range 0-100.Higher scores indicate worse functional status
0-3 months
Tinneti scale.Higher scores indicate better motor function
Time Frame: 0-3 months. Range 0-28
Motor function
0-3 months. Range 0-28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Católica San Antonio de Murcia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2018

Primary Completion (Actual)

December 19, 2018

Study Completion (Actual)

January 7, 2019

Study Registration Dates

First Submitted

February 12, 2021

First Submitted That Met QC Criteria

February 17, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIC06/19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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