Combined Exercise and Nutrition Intervention for Possible Sarcopenia Among Older Adults in Primary Care

Sarcopenia Clinical Trial

Official title:

Combined Exercise and Nutrition Intervention for Possible Sarcopenia Among Community-dwelling Older Adults in Primary Care: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06049914
• Other study ID #: KHMC-SARC-2023
• Status: Recruiting
• Phase: N/A
• Start date: August 8, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Kyunghee University Medical Center
• Contact: Minjin Kim
• Phone: rhdeo64@naver.com
• Email: rhdeo64[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

Inclusion Criteria:

• 65 to 85 years of age

• 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:

• Renal failure: Serum creatine exceeding 2.0 mg/dl

• 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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Behavioral:
• Experimental group
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 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

Locations

Country	Name	City	State
Korea, Republic of	Dongbu-hanil Surgery Clinic	Dobong	Seoul
Korea, Republic of	Dongdong Family Medicine Clinic	Dobong	Seoul
Korea, Republic of	Seoulbom United Clinic	Dobong	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kyunghee University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (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. — View Citation

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. — View Citation

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. Erratum In: Age Ageing. 2019 Jul 1;48(4):601. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Grip strength	Measure maximum grip strength with a grip dynamometer	Screening, 0st week of intervention, 6th week of intervention, 12th week of intervention
Secondary	Falls	Falls Survey in Last 3 Months	0st week of intervention, 12th week of intervention, 24th week of intervention
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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