Depression Clinical Trial
Official title:
National Taipei University of Nursing and Health Sciences
NCT number | NCT04799574 |
Other study ID # | ChenLu |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2, 2018 |
Est. completion date | May 27, 2019 |
Verified date | March 2021 |
Source | National Taipei University of Nursing and Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 75 |
Est. completion date | May 27, 2019 |
Est. primary completion date | May 27, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: 1. Should be at least 65 years old. 2. Should meet one or more of the 5 screening conditions of the Fried Frailty Scale or have a depression index = 15 points. 3. Should be capable of language expression and freedom of movement. Exclusion Criteria: 1. . Those who do not meet the frailty condition or depression tendency 2. . Those who cannot participate in the study in the scheduled time. 3. . Those with difficulty in language expression and mobility. |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taipei University of Nursing and Health Sciences | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taipei University of Nursing and Health Sciences |
Taiwan,
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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 | physical fitness: 30-second sit-to-stand | "30-second sit-to-stand" test in the Senior Fitness Test (SFT), to mainly assess the lower extremity muscle power. The normal value of completing "30-second sit-and-stand" should be greater than 12 times for men and 10 times for women. The more times the better. | 0 weeks(pre-test) | |
Secondary | physical fitness: 30-second sit-to-stand | "30-second sit-to-stand" test in the Senior Fitness Test (SFT), to mainly assess the lower extremity muscle power. The normal value of completing "30-second sit-and-stand" should be greater than 12 times for men and 10 times for women. The more times the better. | 1 week after the 12-week intervention is completed (post-test 1) | |
Secondary | physical fitness: 30-second sit-to-stand | "30-second sit-to-stand" test in the Senior Fitness Test (SFT), to mainly assess the lower extremity muscle power. The normal value of completing "30-second sit-and-stand" should be greater than 12 times for men and 10 times for women. The more times the better. | 4 weeks after the 12-week intervention is completed (post-test 2) | |
Secondary | physical fitness: 2-minute knee bending and leg raising | "2-minute knee bending and leg raising", which is an indicator of endurance in systemic exercise, and the normal values are more than 90 times for men and more than 80 times for women. The more times the better. | 0 weeks(pre-test) | |
Secondary | physical fitness: 2-minute knee bending and leg raising | "2-minute knee bending and leg raising", which is an indicator of endurance in systemic exercise, and the normal values are more than 90 times for men and more than 80 times for women. The more times the better. | 1 week after the 12-week intervention is completed (post-test 1) | |
Secondary | physical fitness: 2-minute knee bending and leg raising | "2-minute knee bending and leg raising", which is an indicator of endurance in systemic exercise, and the normal values are more than 90 times for men and more than 80 times for women. The more times the better. | 4 weeks after the 12-week intervention is completed (post-test 2) | |
Secondary | physical fitness: 2.44 meters of timed get-up-and-go | "2.44 meters of timed get-up-and-go", where the norm for both men and women in Taiwan is ? 8 seconds or walking speed of <0.8 meters/second, The less time the better. | 0 weeks(pre-test) | |
Secondary | physical fitness: 2.44 meters of timed get-up-and-go | "2.44 meters of timed get-up-and-go", where the norm for both men and women in Taiwan is ? 8 seconds or walking speed of <0.8 meters/second, The less time the better. | 1 week after the 12-week intervention is completed (post-test 1) | |
Secondary | physical fitness: 2.44 meters of timed get-up-and-go | "2.44 meters of timed get-up-and-go", where the norm for both men and women in Taiwan is ? 8 seconds or walking speed of <0.8 meters/second, The less time the better. | 4 weeks after the 12-week intervention is completed (post-test 2) | |
Secondary | physical fitness: grip strength | This study uses the Smedlay Dynamometer 100Kg YOII grip strength meter, which is based on the highest retest reliability and uses the average of 2 rounds as the intraclass correlation coefficient (ICC) (ICC = 0.88). This study is based on the Fried Frailty Standard, and the grip strength of the dominant hand is calculated according to the BMI of the elderly. | 0 weeks(pre-test) | |
Secondary | physical fitness: grip strength | This study uses the Smedlay Dynamometer 100Kg YOII grip strength meter, which is based on the highest retest reliability and uses the average of 2 rounds as the intraclass correlation coefficient (ICC) (ICC = 0.88). This study is based on the Fried Frailty Standard, and the grip strength of the dominant hand is calculated according to the BMI of the elderly. | 1 week after the 12-week intervention is completed (post-test 1) | |
Secondary | physical fitness: grip strength | This study uses the Smedlay Dynamometer 100Kg YOII grip strength meter, which is based on the highest retest reliability and uses the average of 2 rounds as the intraclass correlation coefficient (ICC) (ICC = 0.88). This study is based on the Fried Frailty Standard, and the grip strength of the dominant hand is calculated according to the BMI of the elderly. | 4 weeks after the 12-week intervention is completed (post-test 2) | |
Secondary | Conscious health status 1-10 | The researcher drew a 10 cm straight line, with 1 marked on the left end and 10 on the right end, explained the 1 to 10 rating system to the elders, where 1 denotes poor conscious health, 10 denotes very good conscious health, and ? 5 cm or less denotes that the conscious health status is not good. | 0 weeks(pre-test) | |
Secondary | Conscious health status 1-10 | The researcher drew a 10 cm straight line, with 1 marked on the left end and 10 on the right end, explained the 1 to 10 rating system to the elders, where 1 denotes poor conscious health, 10 denotes very good conscious health, and ? 5 cm or less denotes that the conscious health status is not good. | 1 week after the 12-week intervention is completed (post-test 1) | |
Secondary | Conscious health status 1-10 | The researcher drew a 10 cm straight line, with 1 marked on the left end and 10 on the right end, explained the 1 to 10 rating system to the elders, where 1 denotes poor conscious health, 10 denotes very good conscious health, and ? 5 cm or less denotes that the conscious health status is not good. | 4 weeks after the 12-week intervention is completed (post-test 2) |
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