Alzheimer's DiseaseNCT04761497
Effects of Group Music Therapy Interventions on Alzheimer's Disease Patients: a Three-arm Randomized Controlled Blind Study.
A study testing Actice music therapy, Watching nature videos and Passive music therapy in people with Alzheimer's Disease, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Actice music therapy, Watching nature videos and Passive music therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 12 Sep 2018to 7 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Nursing-home dwelling
- Diagnosis of probable Alzheimer's disease
- Mild or moderate stage (Clinical Classification of the Dementia)
Who cannot join
- Aphasia
- Hearing impairment that may affect participation in the activities.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Alzheimer's Disease
- Being tested
- Actice music therapy, Watching nature videos, Passive music therapy
- Keywords
- Alzheimer's disease, cognition., behaviour, function, motor function, active music therapy, passive music therapy
- Medical subject headings
- Alzheimer Disease, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actice music therapyOther
active music therapy sessions for three months
Watching nature videosOther
nature videos sessions for three months
Passive music therapyOther
passive music therapy for three months
| Study group | Role | What they receive |
|---|---|---|
| active music therapy | Experimental | 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. Receives: Other: Actice music therapy |
| passive music therapy | Experimental | 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. Receives: Other: Passive music therapy |
| control | Placebo comparator | Patients were watching nature videos for the same duration than the interventions. A therapist was with them facilitating the activity. Receives: Other: Watching nature videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Examination of the Mental State
Cognitive status. Range 0-30. Higher scores indicate better cognition
Measured: 0-3 months
Neuropsychiatric Inventory
Behavioural disorders. Range 0-144. Higher scores indicate greater behavioural problems
Measured: 0-3 months
Geriatric depression scale
Mood status. Range 0-15. Higher scores indicate worse mood status
Measured: 0-3 months
Barthel index
Functional status. Range 0-100.Higher scores indicate worse functional status
Measured: 0-3 months
Tinneti scale.Higher scores indicate better motor function
Motor function
Measured: 0-3 months. Range 0-28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start12 Sep 2018
- Primary completion19 Dec 2018
- Study completion7 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Gómez-Gallego, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761497
- Sponsor's protocol ID
- PIC06/19
- Status last verified
- Feb 2021
- First submitted
- 12 Feb 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Group Music Therapy Interventions on Alzheimer's Disease Patients: a Three-arm Randomized Controlled Blind Study.
- ClinicalTrials.gov ID
- NCT04761497
- Acronym / sponsor ID
- PIC06/19
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease, cognition., behaviour, function, motor function, active music therapy, passive music therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 12 Sep 2018 (actual)
- Primary completion
- 19 Dec 2018 (actual)
- Study completion
- 7 Jan 2019 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| active music therapy | Experimental | Other: Actice music therapyEach 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 | Experimental | Other: Passive music therapyThe 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 comparator | Other: Watching nature videosPatients were watching nature videos for the same duration than the interventions. A therapist was with them facilitating the activity. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Nursing-home dwelling
- Diagnosis of probable Alzheimer's disease
- Mild or moderate stage (Clinical Classification of the Dementia)
Key exclusion criteria (2 listed)
- Aphasia
- Hearing impairment that may affect participation in the activities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Actice music therapyactive music therapy sessions for three months | Other | active music therapy |
| Watching nature videosnature videos sessions for three months | Other | control |
| Passive music therapypassive music therapy for three months | Other | passive music therapy |
Primary outcome
Mini Examination of the Mental State
Time frame: 0-3 months
Cognitive status. Range 0-30. Higher scores indicate better cognition
Neuropsychiatric Inventory
Time frame: 0-3 months
Behavioural disorders. Range 0-144. Higher scores indicate greater behavioural problems
Geriatric depression scale
Time frame: 0-3 months
Mood status. Range 0-15. Higher scores indicate worse mood status
Barthel index
Time frame: 0-3 months
Functional status. Range 0-100.Higher scores indicate worse functional status
Tinneti scale.Higher scores indicate better motor function
Time frame: 0-3 months. Range 0-28
Motor function
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Actice music therapy, Watching nature videos and Passive music therapy in people with Alzheimer's Disease, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini Examination of the Mental State (time frame: 0-3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.