To determine the effect of neurological music therapy on cognitive function, emotional well being and quality of life among older adults with mild cognitive impairment.
Design
randomization simple random sampling technique with lottery method, parallel group
Settings and conduct
allied hospital Faisalabad
Participants/Inclusion and exclusion criteria
Both Male and female
Presence of MCI (Montreal Cognitive Assessment score < 26)
Being able to walk safely
A low level of physical activity assessed by means of a physical activity questionnaire.
Age 60-80 years
En Older adults with visual impairment and those with hearing problems
History of cardiovascular disease
Presence of neurological disorder ( Parkinson's disease, multiple sclerosis )
Patients having Serious motor deficits
Patient having difficulty in moving and communicating
Left-handed or ambidextrous
Patient having diagnosis of severe cognitive impairment such as dementia.
Presence of depression
Intervention groups
The MMT group participated in a multi task MMT program consisting of exercise therapy with music and use of the Naruko clapper. The STT group participated in exercise sessions that involved the same movements as those in the MMT group. However, in these sessions, the instructor (single task) counted out the movements without accompanying background music or the Naruko clapper.
Main outcome variables
• Cognitive function
• Physical Function
• Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240314061290N1
Registration date:2024-03-27, 1403/01/08
Registration timing:registered_while_recruiting
Last update:2024-03-27, 1403/01/08
Update count:0
Registration date
2024-03-27, 1403/01/08
Registrant information
Name
Irtasam Ahmad
Name of organization / entity
The University Of Faisalabad
Country
Pakistan
Phone
+92 304 6364049
Email address
ahmadirtasam@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-17, 1402/11/28
Expected recruitment end date
2024-03-30, 1403/01/11
Actual recruitment start date
2024-02-17, 1402/11/28
Actual recruitment end date
2024-04-30, 1403/02/11
Trial completion date
2024-05-02, 1403/02/13
Scientific title
Effect of neurological music therapy on older adults with mild cognitive impairment
Public title
neurological music therapy on older adults with mild cognitive impairment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both Male and female
Presence of MCI (Montreal Cognitive Assessment score < 26)
Being able to walk safely
A low level of physical activity assessed by means of a physical activity questionnaire.
Age 60-80 years
Exclusion criteria:
Older adults with visual impairment and those with hearing problems
History of cardiovascular disease
Presence of neurological disorder ( Parkinson's disease, multiple sclerosis )
Patients having Serious motor deficits
Patient having difficulty in moving and communicating
Left-handed or ambidextrous
Patient having diagnosis of severe cognitive impairment such as dementia.
Presence of depression
Age
From 60 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
24
Actual sample size reached:
20
Randomization (investigator's opinion)
Randomized
Randomization description
simple random sampling technique with lottery method.
Blinding (investigator's opinion)
Single blinded
Blinding description
he individuals responsible for assessing or measuring the study outcomes are kept unaware of the participants' treatment group assignments or intervention status.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research and Ethics/technical committe for The University of Faisalabad
Street address
Faisal Town, West Canal Road, Faisalabad Punjab
City
Faisalabad
Postal code
38000
Approval date
2024-01-05, 1402/10/15
Ethics committee reference number
TUF/Addl Reg/SB/764
Health conditions studied
1
Description of health condition studied
Mild cognitive impairment
ICD-10 code
F06.7
ICD-10 code description
A disorder characterized by impairment of memory, learning difficulties, and reduced ability to concentrate on a task for more than brief periods. There is often a marked feeling of mental fatigue when mental tasks are attempted, and new learning is found
Primary outcomes
1
Description
• Cognitive function
Timepoint
Before and after 6 week of intervention
Method of measurement
Mini-mental state examination (MMSE)
Secondary outcomes
1
Description
• Quality of life
Timepoint
Before and after 6 week of intervention
Method of measurement
SF 36 for Quality of life
2
Description
• Physical Function
Timepoint
Before and after 6 week of intervention
Method of measurement
International Physical Activity Questionnaire (IPAQ)
Intervention groups
1
Description
Active Control group: In this control group, an instructor will guide the participants through the same exercises that will perform in the MMT group by giving counts only, without accompanying background music or use of the Naruko clapper. Both interventions will conduct once a week for 12 weeks.
Category
Rehabilitation
2
Description
Intervention group: In the MMT intervention group, each MMT session started with a 20 min warm-up period including about 5 min of light exercise completed in synchronization with background music. The next 15 min involved exercises with background music that aimed to strengthen leg muscles for fall prevention.This was followed by 30 min of MMT during which the participants used the Naruko clapper to accompany the music will play for 4 min, followed by ‘March of 365 steps’ (3 min), ‘Hakodatenohito’ (3 min), ‘Palm in the sun’(3 min), ‘Kiyoshi’s Zundoko’ (4 min), etc. Each session, will select 2 songs music and will repeat them for 30 min. These songs will repeat three times per one song, two songs per a session. It will include an explanation of each move, times to wipe sweat and to water supply between song and song for 2 min. The session will end with relaxation exercises, as well as deep breathing and massage to accompanying background music.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Allied Hospital Faisalabad
Full name of responsible person
Dr. Irtasam Ahmad; PT
Street address
Dr. Tusi Rd, Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Phone
+92 41 9210095
Email
ahmadirtasam@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr. Syed Saqlain Babar; PT
Street address
Faisal Town, West canal Road, Faisalabad Punjab
City
Faisalabad
Postal code
38000
Phone
+92 315 6205017
Email
syedsaqlain264@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Faisalabad
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr. Zainab Boota;PT
Position
Consultant clinical physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faisal Town, West Canall Road, Faisalabad, Punjab
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
0092 41 3357916317
Email
zainboota9698@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr. Warda Jabbar;PT
Position
Consultant clinical physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faisal Town, West Canal Road, Faisalabad, Punjab
City
Faisalabad
Province
Punajb
Postal code
38000
Phone
0092 41 313 8650848
Email
Wardah.jabbar5@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr. Irtasam Ahmad;PT
Position
Consulant clinical physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faisal Town, West Canal Road, Faisalabad, Punjab
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 6977849
Email
ahmadirtasam@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Effect of neurological music therapy on older adults with mild cognitive impairment
When the data will become available and for how long
15 days after publication
To whom data/document is available
Google scholar
Under which criteria data/document could be used
Access to the data will be facilitated through a specified mechanism, such as a secure online portal or data sharing platform. Requests for access will be reviewed by a designated committee or entity responsible for ensuring that they meet the established criteria and comply with relevant regulations and guidelines. Additional supporting information and documents may be provided to assist requesters
From where data/document is obtainable
The University of Faisalabad 38000 https://tuf.edu.pk/ 00924187509715
What processes are involved for a request to access data/document
To receive the documents or data files, the process typically involves the following steps: 1. Request Initiation: The applicant submits a formal request specifying the documents or data files they need. 2. Verification and Authorization: The organization verifies the request and ensures that the applicant is authorized to access the requested documents or data files. This may involve confirming the identity of the requester and checking their permissions. 3. Processing Time: The processing time varies depending on the complexity of the request, the volume of documents or data files, and any legal or regulatory requirements. It could range from a few hours to several weeks. 4. Document Retrieval or Data Extraction: Once the request is approved, the organization retrieves the documents from their archives or extracts the requested data from their databases. 5. Quality Assurance: Before releasing the documents or data files to the applicant, the organization may conduct quality checks to ensure accuracy and completeness. 6. Delivery: The documents or data files are delivered to the applicant through a secure channel, such as encrypted email, secure file transfer protocols, or a secure online portal. 7. Confirmation of Receipt: The applicant acknowledges receipt of the documents or data files, confirming that they have received the information they requested.