Effect of Music Therapy in Improving the Physical Fitness and Depression in the Frailty of the Community Elderly

NCT04799574 | Completed DMC

• 1 other identifier: ChenLu
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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, 2.44 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.

Conditions

Music Therapy; Frailty; Physical Fitness; Depression

Keywords

music therapy; frailty; physical fitness; depression; activity

Outcome Measures

Primary Outcomes (6)

• Depression index

  This study uses the Taiwan Geriatric Depression Scale (TGDS-30), which has a total of 30 questions. The answers are dichotomous (yes/no), and are scored between 0-30 points, where a total score of more than 15 points means one is suspected of suffering from depression, and a higher score indicates a higher degree of depression.

  0 weeks(pre-test)

• Depression index

  This study uses the Taiwan Geriatric Depression Scale (TGDS-30), which has a total of 30 questions. The answers are dichotomous (yes/no), and are scored between 0-30 points, where a total score of more than 15 points means one is suspected of suffering from depression, and a higher score indicates a higher degree of depression.

  1 week after the 12-week intervention is completed (post-test 1)

• Depression index

  This study uses the Taiwan Geriatric Depression Scale (TGDS-30), which has a total of 30 questions. The answers are dichotomous (yes/no), and are scored between 0-30 points, where a total score of more than 15 points means one is suspected of suffering from depression, and a higher score indicates a higher degree of depression.

  4 weeks after the 12-week intervention is completed (post-test 2)

• The International Physical Activity Questionnaire Short Form (IPAQ-SF)

  This study adopted the Taiwanese Chinese version of the activity test scale of the International Physical Activity Questionnaire-Self-filled short version (IPAQ-SF), as translated and developed by Professor Liu Ying Mei in cooperation with the Ministry of Health and Welfare. The contents of the self-filled Chinese version conform to create valid content with meanings similar to the English version, .994, and .992, respectively. The intrinsic level of the correlation coefficient of the Chinese and English versions is .704, which has good reliability and validity, as well as cultural sensitivity. The IPAQ short version includes walking (W), medium-intensity activity (M), high-intensity activity (V), and overall physical activity scores. All consecutive scores are expressed in METs-minutes/week. Walking=3.3METS, medium-intensity activity=4.0METS, high-intensity activity=8.0METSThe higher the score, the higher the level of participation in the activity.

  0 weeks(pre-test)

• The International Physical Activity Questionnaire Short Form (IPAQ-SF)

  This study adopted the Taiwanese Chinese version of the activity test scale of the International Physical Activity Questionnaire-Self-filled short version (IPAQ-SF), as translated and developed by Professor Liu Ying Mei in cooperation with the Ministry of Health and Welfare. The contents of the self-filled Chinese version conform to create valid content with meanings similar to the English version, .994, and .992, respectively. The intrinsic level of the correlation coefficient of the Chinese and English versions is .704, which has good reliability and validity, as well as cultural sensitivity. The IPAQ short version includes walking (W), medium-intensity activity (M), high-intensity activity (V), and overall physical activity scores. All consecutive scores are expressed in METs-minutes/week. Walking=3.3METS, medium-intensity activity=4.0METS, high-intensity activity=8.0METSThe higher the score, the higher the level of participation in the activity.

  1 week after the 12-week intervention is completed (post-test 1)

• The International Physical Activity Questionnaire Short Form (IPAQ-SF)

  This study adopted the Taiwanese Chinese version of the activity test scale of the International Physical Activity Questionnaire-Self-filled short version (IPAQ-SF), as translated and developed by Professor Liu Ying Mei in cooperation with the Ministry of Health and Welfare. The contents of the self-filled Chinese version conform to create valid content with meanings similar to the English version, .994, and .992, respectively. The intrinsic level of the correlation coefficient of the Chinese and English versions is .704, which has good reliability and validity, as well as cultural sensitivity. The IPAQ short version includes walking (W), medium-intensity activity (M), high-intensity activity (V), and overall physical activity scores. All consecutive scores are expressed in METs-minutes/week. Walking=3.3METS, medium-intensity activity=4.0METS, high-intensity activity=8.0METSThe higher the score, the higher the level of participation in the activity.

  4 weeks after the 12-week intervention is completed (post-test 2)

Secondary Outcomes (15)

• physical fitness: 30-second sit-to-stand

  0 weeks(pre-test)

• physical fitness: 30-second sit-to-stand

  1 week after the 12-week intervention is completed (post-test 1)

• physical fitness: 30-second sit-to-stand

  4 weeks after the 12-week intervention is completed (post-test 2)

• physical fitness: 2-minute knee bending and leg raising

  0 weeks(pre-test)

• physical fitness: 2-minute knee bending and leg raising

  1 week after the 12-week intervention is completed (post-test 1)

Study Arms (2)

music therapy activity

EXPERIMENTAL

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.

Other: music therapy activities

Health education lecture

PLACEBO COMPARATOR

routine activities of community

Other: music therapy activities

Interventions

music therapy activities OTHER

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.

Health education lecture; music therapy activity

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Should be at least 65 years old.
• Should meet one or more of the 5 screening conditions of the Fried Frailty Scale or have a depression index ≥ 15 points.
• Should be capable of language expression and freedom of movement.

You may not qualify if:

• Those who do not meet the frailty condition or depression tendency
• Those who cannot participate in the study in the scheduled time.
• Those with difficulty in language expression and mobility.

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead

Study Sites (1)

National Taipei University of Nursing and Health Sciences

Taipei, 112, Taiwan

Location

Related Publications (11)

• Drey M, Pfeifer K, Sieber CC, Bauer JM. The Fried frailty criteria as inclusion criteria for a randomized controlled trial: personal experience and literature review. Gerontology. 2011;57(1):11-8. doi: 10.1159/000313433. Epub 2010 Apr 21.

  PMID: 20407227 RESULT

• Mahendran R, Rawtaer I, Fam J, Wong J, Kumar AP, Gandhi M, Jing KX, Feng L, Kua EH. Art therapy and music reminiscence activity in the prevention of cognitive decline: study protocol for a randomized controlled trial. Trials. 2017 Jul 12;18(1):324. doi: 10.1186/s13063-017-2080-7.

  PMID: 28701205 RESULT

• Castaneda-Gameros D, Redwood S, Thompson JL. Physical Activity, Sedentary Time, and Frailty in Older Migrant Women From Ethnically Diverse Backgrounds: A Mixed-Methods Study. J Aging Phys Act. 2018 Apr 1;26(2):194-203. doi: 10.1123/japa.2016-0287. Epub 2018 Mar 23.

  PMID: 28605284 RESULT

• Dumitrache CG, Rubio L, Rubio-Herrera R. Perceived health status and life satisfaction in old age, and the moderating role of social support. Aging Ment Health. 2017 Jul;21(7):751-757. doi: 10.1080/13607863.2016.1156048. Epub 2016 Mar 8.

  PMID: 26954480 RESULT

• Vuilleumier P, Trost W. Music and emotions: from enchantment to entrainment. Ann N Y Acad Sci. 2015 Mar;1337:212-22. doi: 10.1111/nyas.12676.

  PMID: 25773637 RESULT

• Kim JH, Kim JM. Subjective life expectancy is a risk factor for perceived health status and mortality. Health Qual Life Outcomes. 2017 Oct 2;15(1):190. doi: 10.1186/s12955-017-0763-0.

  PMID: 28969645 RESULT

• Modig S, Midlov P, Kristensson J. Depressive symptoms among frail elderly in ordinary living: who is affected and who is treated? Aging Ment Health. 2014;18(8):1022-8. doi: 10.1080/13607863.2014.903469. Epub 2014 Apr 7.

  PMID: 24708142 RESULT

• Ishikawa M, Yamanaka G, Yamamoto N, Nakaoka T, Okumiya K, Matsubayashi K, Otsuka K, Sakura H. Depression and Altitude: Cross-Sectional Community-Based Study Among Elderly High-Altitude Residents in the Himalayan Regions. Cult Med Psychiatry. 2016 Mar;40(1):1-11. doi: 10.1007/s11013-015-9462-7.

  PMID: 26162459 RESULT

• Costa SN, Vieira ER, Bento PCB. Effects of Home- and Center-Based Exercise Programs on the Strength, Function, and Gait of Prefrail Older Women: A Randomized Control Trial. J Aging Phys Act. 2020 Jan 1;28(1):122-130. doi: 10.1123/japa.2018-0363.

  PMID: 31629355 RESULT

• Leiros-Rodriguez R, Soto-Rodriguez A, Perez-Ribao I, Garcia-Soidan JL. Comparisons of the Health Benefits of Strength Training, Aqua-Fitness, and Aerobic Exercise for the Elderly. Rehabil Res Pract. 2018 Jun 19;2018:5230971. doi: 10.1155/2018/5230971. eCollection 2018.

  PMID: 30018825 RESULT

• Lohne-Seiler H, Kolle E, Anderssen SA, Hansen BH. Musculoskeletal fitness and balance in older individuals (65-85 years) and its association with steps per day: a cross sectional study. BMC Geriatr. 2016 Jan 12;16:6. doi: 10.1186/s12877-016-0188-3.

  PMID: 26755421 RESULT

MeSH Terms

Conditions

Frailty; Depression; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Miao Yen Chen, Ph.D.

  National Taipei University of Nursing and Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The researchers in this study are the leaders of the activities and the nurses who had completed training in music therapy courses, and had obtained leadership certificates and qualifications in senior music activities.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate of Master Degree, RN.

Model Details: one Experimental group and one Control group

Study Record Dates

• First Submitted: June 7, 2020
• First Posted: March 16, 2021
• Study Start: October 2, 2018
• Primary Completion: May 27, 2019
• Study Completion: May 27, 2019
• Last Updated: March 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)