An interventional study of Experimental group in Sarcopenia, sponsored by Kyunghee University Medical Center. Recruiting at 3 sites in Korea, Republic of. Open to participants aged 65 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-09-22.
Sponsored by Kyunghee University Medical Center · Not applicable, Interventional, and Screening
The purpose of this study is to assess the impact of a combined exercise-nutrition intervention in primary clinics on sarcopenia indices, physical function, and quality of life in community-dwelling older adults with possible sarcopenia.
This study will investigate the effects of a 12-week combined exercise-nutrition intervention by comparing it with a control group receiving standard care (usual care) by assessing the sarcopenia indicators, functional recovery, and individual satisfaction. This is an interventional clinical study designed to recruit subjects, analyze data, identify problems, find improvement areas, and explore potential solutions.
1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.
This study's planned enrollment of 94 is above the median of 60 across 775 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →Kyunghee University Medical Center is the lead sponsor of 62 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Men and women with possible sarcopenia
Exclusion Criteria:
1. Exercise interventions * Visiting the primary clinic twice a week and exercising at home once a week for a total of 6 weeks during the introductory and expanding period, and then visiting the primary clinic once a week and exercising at home twice a week for 6 weeks during the maintenance period * For exercise intervention, the researcher visits the primary clinic and conducts it face-to-face * Flexibility and strength Exercises: Up to 4 group exercises under the guidance of researchers, up to 40 minutes scheduled 2. Nutritional interventions * Evaluate nutritional status through Mini Nutritional Assessment(MNA) survey at the time of Visit 1 * Supplementary protein products are provided only for the malnourished group and at risk group with a MNA score of 23.5 or lower * Supplementary protein products: 'Mediwell', healthy five-grain flavor, liquid 150 ml, 150 kcal, 20g carbohydrates, 2g sugars, 8g protein, 5g fat
Behavioral: Experimental group
* Control group: Providing only video and educational materials without intervention (12 weeks) * Videos and educational materials are provided to both the experimental group and the control group for home exercise. * Subjects write flexibility exercises, strength exercises, aerobic exercises, and meal diaries at home.
1. Exercise interventions * Measuring blood pressure and weight: before starting exercise * Flexibility exercises: 5-10 minutes of stretching * Strength exercises: Consists of 4 upper body exercises (Biceps Curl, Dips, Front raise, Chest press) and 5 lower body exercises (Leg lateral rotation, Leg extension, Hip abduction, Squat, Heel raise). The intensity of the band starts according to the subject's muscle strength. * Aerobic exercise: 5 times a week, home-based, 30 minutes or more each time 2. Nutritional interventions * Well nourished: Overall diet check and correction * at risk: Correction of diet and intake of up to 2 packs of supplemental protein products per day * Malnourished: Correction of diet and intake of up to 3 packs of supplemental protein products per day * Nutrition counseling is provided at the beginning of the intervention and high-protein diet composition education is provided * Confirm compliance and provide feedback once every 2 weeks
5-time chair stand test
a test of lower limb function that measures the fastest time taken to stand five times from a chair with arms folded.
Time frame: Screening, 0st week of intervention, 6th week of intervention, 12th week of intervention
Grip strength
Measure maximum grip strength with a grip dynamometer
Time frame: Screening, 0st week of intervention, 6th week of intervention, 12th week of intervention
Falls
Falls Survey in Last 3 Months
Time frame: 0st week of intervention, 12th week of intervention, 24th week of intervention
EuroQol Visual Analogue Scale(EQ-VAS)
a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.
Time frame: 0st week of intervention, 12th week of intervention
Korean version of Instrumental Activities of Daily Living (K-IADL)
Assess the skills and abilities needed to perform specific daily tasks related to an independent lifestyle in Korean version.
Time frame: 0st week of intervention, 6th week of intervention, 12th week of intervention, 24th week of intervention
Korean version of Physical Activity Scale for the Elderly(K-PASE)
Measures the level of self-reported physical activity in individuals aged 65 years or older and is comprised of items regarding occupational, household, and leisure activities during the previous 7-day period.
Time frame: 0st week of intervention, 12th week of intervention
Mini Nutritional Assessment(MNA)
Mini Nutritional Assessment is a validated nutrition screening and assessment tool that can identify geriatric patients age 65 and above who are malnourished or at risk of malnutrition.
Time frame: 0st week of intervention, 12th week of intervention
Korean version of Mini-mental State Examination(K-MMSE)
a set of questions that commonly used to check for cognitive impairment (problems with thinking, communication, understanding and memory).
Time frame: 0st week of intervention, 12th week of intervention
Korean version of Short Form of Geriatric Depression Scale(SGDS-K)
Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.
Time frame: 0st week of intervention, 12th week of intervention, 24th week of intervention
The 12-item Health Survey(SF-12)
Self-reported outcome measure assessing the impact of health on an individual's everyday life. It is used as a quality of life measure.
Time frame: 0st week of intervention, 12th week of intervention
Plan to share: Yes — Research information will be provided to third parties (data processing organizations, academic societies, etc.) and used for secondary research. Individual participant data will be stored and used for 5 years after completion of the primary study. When used for secondary research, it will be used after deliberation by the institutional committee, and all information provided will be used only to create statistics for research purposes. The purpose and expected effect of third-party provision of research information and use of secondary research is to contribute to the promotion of national health. Personal information to be collected: Personal identification information (date of birth, name, gender, etc.), personal information (medical records necessary to determine the purpose of this study)
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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Kyunghee University Medical Center