Combined Exercise and Nutrition Intervention for Possible Sarcopenia Among Older Adults in Primary Care
NCT ID: NCT06049914
Last Updated: 2023-09-22
Study Results
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Basic Information
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UNKNOWN
NA
94 participants
INTERVENTIONAL
2023-08-08
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
DOUBLE
Study Groups
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Experimental group
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
Experimental group
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
Control 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.
No interventions assigned to this group
Interventions
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Experimental group
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
Eligibility Criteria
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Inclusion Criteria
* Men and women with possible sarcopenia
* If included in the possible sarcopenia criteria in the 2019 Asian Working Group for Sarcopenia(AWGS) criteria A Simple Questionnaire to Rapidly Diagnose Sarcopenia(The Korean SARC-F questionnaire) score is 4 or higher; or Calf circumference (Men's: \<34 cm, Women's: \<33 cm) + Decreased muscle strength (male: \<28kg, female: \<18kg) or Decreased physical function (if it takes more than 12 seconds from the 5-chair stand test)
* \[(1) and {(2) or (3)}\]
Exclusion Criteria
* Uncontrolled hypertension: systolic/diastolic blood pressure greater than 150/90 millimeter of mercury(mmHg)
* Uncontrolled diabetes: glycated hemoglobin (HbA1C) over 7.5%
* Subject who are receiving treatment (steroids, anticancer drugs, etc.) that can affect muscle mass
* Subjects with myocardial infarction or angina pectoris, stroke disease
* Malignant tumor: Subject who has a history of cancer within 5 years or is currently receiving treatment
* Subjects who have liver cirrhosis and uncontrolled hepatitis (Aspartate aminotransferase or Alanine aminotransferase is more than three times the upper limit of the reference range)
* Subjects who have chronic diseases such as musculoskeletal disorders that are impossible to exercise
* Subjects who are allergic to soybeans, coix, and brown rice
65 Years
85 Years
ALL
No
Sponsors
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Kyunghee University Medical Center
OTHER
Responsible Party
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Chang Won Won
Principal Investigator
Principal Investigators
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Chang Won Won, MD
Role: PRINCIPAL_INVESTIGATOR
Kyunghee University Medical Center
Ja Euk Baek
Role: STUDY_DIRECTOR
Dongdong Family Medicine Clinic
Seong Euk Kim
Role: STUDY_DIRECTOR
Dongbu-hanil Surgery Clinic
Chung Hyeong Lee
Role: STUDY_DIRECTOR
Seoulbom United Clinic
Mi Ji Kim
Role: STUDY_DIRECTOR
Kyunghee University
Seon Yeong Kim
Role: STUDY_DIRECTOR
Kyunghee University Medical Center
Jeong Ha Kim
Role: STUDY_DIRECTOR
Chung-Ang University
Jeong Ha Park
Role: STUDY_DIRECTOR
Kyunghee University Medical Center
Ga Yang Shim
Role: STUDY_DIRECTOR
Kyunghee University Medical Center
Hye Suk Lee
Role: STUDY_CHAIR
Kyunghee University Medical Center
Dae Hyun Lee
Role: STUDY_CHAIR
Kyunghee University
Hee Eun Jung
Role: STUDY_CHAIR
Kyunghee University
Jae Young Jang
Role: STUDY_CHAIR
Kyunghee University
Na Hyun Lim
Role: STUDY_CHAIR
Kyunghee University
Hyun jin Cho
Role: STUDY_CHAIR
Kyunghee University
Min JIn Kim
Role: STUDY_CHAIR
Kyunghee University
Woohyuk Ji
Role: STUDY_CHAIR
Kyunghee University Medical Center
Locations
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Dongdong Family Medicine Clinic
Dobong, Seoul, South Korea
Dongbu-hanil Surgery Clinic
Dobong, Seoul, South Korea
Seoulbom United Clinic
Dobong, Seoul, South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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KHMC-SARC-2023
Identifier Type: -
Identifier Source: org_study_id
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