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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental |
|
|
| Control group | No Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental group | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Screening, 0st week of intervention, 6th week of intervention, 12th week of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Grip strength | Measure maximum grip strength with a grip dynamometer | Screening, 0st week of intervention, 6th week of intervention, 12th week of intervention |
| Falls | Falls Survey in Last 3 Months |
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Inclusion Criteria:
65 to 85 years of age
Men and women with possible sarcopenia
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Minjin Kim | Contact | rhdeo64@naver.com | +821030741008 | rhdeo64@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Chang Won Won, MD | Kyunghee University Medical Center | Principal Investigator |
| Ja Euk Baek | Dongdong Family Medicine Clinic | Study Director |
| Seong Euk Kim |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongdong Family Medicine Clinic | Recruiting | Dobong | Seoul | 01384 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30498820 | Background | Dent E, Morley JE, Cruz-Jentoft AJ, Arai H, Kritchevsky SB, Guralnik J, Bauer JM, Pahor M, Clark BC, Cesari M, Ruiz J, Sieber CC, Aubertin-Leheudre M, Waters DL, Visvanathan R, Landi F, Villareal DT, Fielding R, Won CW, Theou O, Martin FC, Dong B, Woo J, Flicker L, Ferrucci L, Merchant RA, Cao L, Cederholm T, Ribeiro SML, Rodriguez-Manas L, Anker SD, Lundy J, Gutierrez Robledo LM, Bautmans I, Aprahamian I, Schols JMGA, Izquierdo M, Vellas B. International Clinical Practice Guidelines for Sarcopenia (ICFSR): Screening, Diagnosis and Management. J Nutr Health Aging. 2018;22(10):1148-1161. doi: 10.1007/s12603-018-1139-9. | |
| 30312372 |
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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)
It will be distributed for storage/management/connection/provision for 5 years from the end of primary research by a data management agency determined by the Minister of Health and Welfare, and will be provided upon request by researchers for secondary research use only within that period.
After deliberation by the institutional committee, it will be provided and utilized only for research that is judged to be of public interest through the Data Provision Deliberation Committee*.
*Formation of a future data provision deliberation committee
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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12-week combined exercise-nutrition intervention
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|
| 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. | 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. | 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. | 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. | 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). | 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. | 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. | 0st week of intervention, 12th week of intervention |
| Dongbu-hanil Surgery Clinic |
| Study Director |
| Chung Hyeong Lee | Seoulbom United Clinic | Study Director |
| Mi Ji Kim | Kyunghee University | Study Director |
| Seon Yeong Kim | Kyunghee University Medical Center | Study Director |
| Jeong Ha Kim | Chung-Ang University | Study Director |
| Jeong Ha Park | Kyunghee University Medical Center | Study Director |
| Ga Yang Shim | Kyunghee University Medical Center | Study Director |
| Hye Suk Lee | Kyunghee University Medical Center | Study Chair |
| Dae Hyun Lee | Kyunghee University | Study Chair |
| Hee Eun Jung | Kyunghee University | Study Chair |
| Jae Young Jang | Kyunghee University | Study Chair |
| Na Hyun Lim | Kyunghee University | Study Chair |
| Hyun jin Cho | Kyunghee University | Study Chair |
| Min JIn Kim | Kyunghee University | Study Chair |
| Woohyuk Ji | Kyunghee University Medical Center | Study Chair |
| Dongbu-hanil Surgery Clinic | Recruiting | Dobong | Seoul | South Korea |
|
| Seoulbom United Clinic | Recruiting | Dobong | Seoul | South Korea |
|
| Background |
| Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169. |
| 32033882 | Background | Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4. |
| 32743250 | Background | Jang HC. How to Diagnose Sarcopenia in Korean Older Adults? Ann Geriatr Med Res. 2018 Jun;22(2):73-79. doi: 10.4235/agmr.2018.22.2.73. Epub 2018 Jun 30. |
| 28539168 | Background | Malafarina V, Uriz-Otano F, Malafarina C, Martinez JA, Zulet MA. Effectiveness of nutritional supplementation on sarcopenia and recovery in hip fracture patients. A multi-centre randomized trial. Maturitas. 2017 Jul;101:42-50. doi: 10.1016/j.maturitas.2017.04.010. Epub 2017 Apr 22. |
| 28935775 | Background | Nipp RD, Fuchs G, El-Jawahri A, Mario J, Troschel FM, Greer JA, Gallagher ER, Jackson VA, Kambadakone A, Hong TS, Temel JS, Fintelmann FJ. Sarcopenia Is Associated with Quality of Life and Depression in Patients with Advanced Cancer. Oncologist. 2018 Jan;23(1):97-104. doi: 10.1634/theoncologist.2017-0255. Epub 2017 Sep 21. |
| 30462162 | Background | Zhu LY, Chan R, Kwok T, Cheng KC, Ha A, Woo J. Effects of exercise and nutrition supplementation in community-dwelling older Chinese people with sarcopenia: a randomized controlled trial. Age Ageing. 2019 Mar 1;48(2):220-228. doi: 10.1093/ageing/afy179. |
| 30864254 | Background | Yamada M, Kimura Y, Ishiyama D, Nishio N, Otobe Y, Tanaka T, Ohji S, Koyama S, Sato A, Suzuki M, Ogawa H, Ichikawa T, Ito D, Arai H. Synergistic effect of bodyweight resistance exercise and protein supplementation on skeletal muscle in sarcopenic or dynapenic older adults. Geriatr Gerontol Int. 2019 May;19(5):429-437. doi: 10.1111/ggi.13643. Epub 2019 Mar 13. |
| 30243898 | Background | Chen HT, Wu HJ, Chen YJ, Ho SY, Chung YC. Effects of 8-week kettlebell training on body composition, muscle strength, pulmonary function, and chronic low-grade inflammation in elderly women with sarcopenia. Exp Gerontol. 2018 Oct 2;112:112-118. doi: 10.1016/j.exger.2018.09.015. Epub 2018 Sep 20. |
| 30486262 | Background | Tsekoura M, Billis E, Tsepis E, Dimitriadis Z, Matzaroglou C, Tyllianakis M, Panagiotopoulos E, Gliatis J. The Effects of Group and Home-Based Exercise Programs in Elderly with Sarcopenia: A Randomized Controlled Trial. J Clin Med. 2018 Nov 26;7(12):480. doi: 10.3390/jcm7120480. |
| 10690696 | Background | Lauque S, Arnaud-Battandier F, Mansourian R, Guigoz Y, Paintin M, Nourhashemi F, Vellas B. Protein-energy oral supplementation in malnourished nursing-home residents. A controlled trial. Age Ageing. 2000 Jan;29(1):51-6. doi: 10.1093/ageing/29.1.51. |
| 34311098 | Background | Laddu D, Kim H, Phillips SA, Ma J. INERTIA: A pilot study of the impact of progressive resistance training on blood pressure control in older adults with sarcopenia. Contemp Clin Trials. 2021 Sep;108:106516. doi: 10.1016/j.cct.2021.106516. Epub 2021 Jul 24. |
| 23851406 | Background | Thompson PD, Arena R, Riebe D, Pescatello LS; American College of Sports Medicine. ACSM's new preparticipation health screening recommendations from ACSM's guidelines for exercise testing and prescription, ninth edition. Curr Sports Med Rep. 2013 Jul-Aug;12(4):215-7. doi: 10.1249/JSR.0b013e31829a68cf. No abstract available. |
| 39443873 | Derived | Ji W, Lee D, Kim M, Lim N, Lim JY, Baek JU, Kim S, Lee CH, Kim M, Won CW. Efficacy of a combined exercise and nutrition intervention study for outpatients with possible sarcopenia in community-based primary care clinics (ENdSarC): study protocol for a multicenter single-blinded randomized controlled trial. BMC Geriatr. 2024 Oct 23;24(1):861. doi: 10.1186/s12877-024-05434-y. |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D001519 | Behavior |