Viewing Study NCT04799574



Ignite Creation Date: 2024-05-06 @ 3:53 PM
Last Modification Date: 2024-10-26 @ 1:59 PM
Study NCT ID: NCT04799574
Status: COMPLETED
Last Update Posted: 2021-03-19
First Post: 2020-06-07

Brief Title: Effect of Music Therapy in Improving the Physical Fitness and Depression in the Frailty of the Community Elderly
Sponsor: National Taipei University of Nursing and Health Sciences
Organization: National Taipei University of Nursing and Health Sciences

Study Overview

Official Title: National Taipei University of Nursing and Health Sciences
Status: COMPLETED
Status Verified Date: 2021-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Research Design This study adopted randomized clinical trials design with two groups of pre-tests and post-tests a single-blind test a single-blind test and intentional sampling Four well-organized community care centers with the proper number of elderly people and the willingness to participate in Taipei City were selected to carry out the pre-test to screen out the qualified research subjects and then they were randomly assigned to the experimental group or control group The experimental group received music therapy and routine activities while the control group only received routine activities and the researchers were the leaders of the music therapy activities Data collection and fitness testing were performed by trained certified and qualified personnel Before program implementation a consensus meeting on testing consistency was conducted for the testers to obtain consistency in testing technology and scale questionnaires The researchers were not involved in the testing in order to ensure the independent position and blindness of the fitness testers The study intervention was conducted for 12 weeks once a week 90 minutes each time In the 13th week the two groups performed the first post-test while the second post-test was in the 16th week

Research Structure The independent variables include demographic data and one or more of the five indicators of disease state and physical status decline The intervention measures include various music therapy activities and the dependent variables are the performance indicators including frailty indicators BMI grip strength 244 meters of timed get-up-and-go 30 seconds of sit-to-stand 2 minutes of knee bending and leg raising physical activity conscious health status and depression This study explores the effectiveness of music therapy in improving the physical fitness degree of activity and depression of elderly in the community
Detailed Description: Music therapy activity course design Protocol

The researchers in this study are the leaders of the activities and the nurses who had completed training in music therapy courses and obtained a senior music activity leadership certificate and qualification such as books and internship certificates The course design uses the percussion music theory and Dalcroze and Orpff music pedagogy to plan activities as follows

Each class in the music therapy activity course design has a fixed process The 90-minute course includes 10-15 minutes of warm-up activities 50-60 minutes of main activities 10-15 minutes of recovery activities and 10 minutes of rest for the elders in the middle The content of the weekly main activities uses different music musical instruments props or rhythms to lead the rhythm music activities

Research Subjects

1 The case acceptance conditions of this study are as follows

The case should be at least 65 years old The case should meet one or more of Fried Frailtys 5 screening conditions or have a depression index 15 points

The case should be capable of language expression and freedom of movement 2 The exclusion conditions are as follows

1 Those who do not meet the frailty condition and depression tendency 2 Those who cannot participate in the study in the scheduled time 3 Those with difficulty in language expression and mobility Research Structure The independent variables include demographic data and one or more of the five indicators of disease state and physical status decline The intervention measures are various activities of music therapy and the dependent variables are the performance indicators including frailty indicators BMI grip strength 244 meters of time get-up-and-go 30 seconds of sit-to-stand 2 minutes of knee bending and leg raising physical activity conscious health status and depression Explore the effectiveness of music therapy in improving the physical fitness activity and depression of the elderly in the community

Definition of terms and use of tools

Demographic variables refer to

The basic data of the research subjects including 8 items such as age gender education level marital status living situation economic source economic status and food preparation methods

The disease state refers to

Study the physical health status of the research subjects including types of chronic diseases types of drugs taken daily conscious health status and emotional status

Music therapy

It refers to the music activities led by the medical staff who had completed training in music therapy courses during the entire research program with the curriculum designed to suit the health needs of the elder group The researchers in this study are the leaders of the activities and also the nurses who had completed training in music therapy courses and obtained a senior music activity leadership certificate and qualifications such as books and internship certificates The course design uses percussion music theory and Dalcroze and Orpff music pedagogy to plan activities

Physical fitness

The physical fitness in this study mainly includes cardiopulmonary endurance muscle power and body mass index Muscle power test measures the grip strength of the dominant hand and lower limb muscle power This study uses Smedlay Dynamometer 100Kg YOII model grip strength meter its retest reliability is based on the highest retest reliability using the average of 2 rounds of the intraclass correlation coefficient ICC ICC 088 This study is based on the Fried Frailty Standard and the grip strength of the dominant hand is calculated by the BMI of the elderly Lower extremity muscle power is the ability to assess the individuals movement capacity and is tested with the 30-second sit-to-stand test in Senior Fitness Test SFT published by Rikil and Jones in 1999 to mainly access the lower extremity muscle power and daily life movement capacity of the elderly The physical fitness of the elderly in this study is determined by the Health Promotion Administration fitness test The normal value of 30-second sit-and-stand should be greater than 12 times for men and 10 times for women cardiopulmonary endurance is measured by 244 meters of time get-up-and-go and 2-minute knee bending and leg raising The norm of men and womens 244 meters of time get-up-and-go in Taiwan is 8 seconds or walking speed 08 meterssecond 2-minute knee bending and leg raising is an indicator of the endurance of systemic exercise The normal value is more than 90 times for men and more than 80 times for women

Activity

In this study the activity test scale-International Physical Activity Questionnaire-Self-filled short version of Taiwan Chinese version International Physical Activity Questionnaire IPAQ-SF translated and developed by Professor Liu Yingmei in cooperation with Ministry of Health and Welfare was adopted In the self-filled Chinese version the English and Chinese language conformity and the content validity index of similarity of meaning are 994 and 992 the intrinsic level correlation coefficient of the Chinese and English versions is 704 which has good reliability and validity as well as cultural sensitivity

Depression

This study uses the Taiwan Geriatric Depression Scale TGDS-30 The scale has a total of 30 questions The question is answered based on the condition of the last week It can be self-filled or structured The answer is dichotomous yesno with a total score of 0-30 points A total score of more than 15 points means one is suspected of suffering from depression A higher score indicates a higher degree of depression Therefore the standard for accepting cases in this study is TGDS-30 depression index 15 points In terms of reliability of this scale the Cronbachα value of the overall scale is 094 the retest reliability is 082 and the halving reliability is 095 in terms of validity the validity and reliability have 933 sensitivity and 923 specificity so it is a test scale with good reliability and validity

Frailty

It refers to the Health Promotion Administration Assessment Standards for Physical Fitness of the Elderly and the criteria for five indicators of frailty proposed by Fried in 2001 for the indicators of frailty Failure to meet any of the indicators means no frailty meeting one or two indicators are pre-frailty and meeting three or more indicators are frailty

This study accepts the case who meets one or more indicators

Conscious health status

The researcher draws a 10 cm straight line on the white paper with 1 marked on the left end and 10 on the right end explains the meaning of 1 and 10 to the elders and asks the elders to point out the conscious health status on the line Then the researcher measures the score with a ruler and the data is calculated to the first decimal point From 1-10 1 means poor conscious health 10 means very good conscious health and 5 cm or less means that the conscious health status is not good

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None