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SarcopeniaNCT06049914

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

A study testing Experimental group in people with Sarcopenia, run by Kyunghee University Medical Center at 3 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 65 to 85 years
Conditions the study is for
Sarcopenia
What is being tested?
Experimental group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
3 sitesSouth Korea
Study dates
8 Aug 2023to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 85 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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)}]

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

Minjin Kim contact

rhdeo64@naver.com ext. +821030741008

rhdeo64@naver.com

South Korea3 sites, 3 recruiting

  • Dongdong Family Medicine Clinic

    Dobong, Seoul, 01384

    Jaeuk Baek, +82 10-9904-8803 ext. +82 956-0415, tendobaek@hanmail.net

    Recruiting

  • Dongbu-hanil Surgery Clinic

    Dobong, Seoul

    Seong Euk Kim, +82 10-9416-7369 ext. +82 3492-4754, podobear@hanmail.net

    Recruiting

  • Seoulbom United Clinic

    Dobong, Seoul

    Chung Hyeong Lee, +82 10-2534-3302 ext. +82 -907-0304, leech98@gmail.com

    Recruiting

Other trials in South Korea

About this study

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

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.

Read the detailed 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.

Conditions
Sarcopenia
Being tested
Experimental group
Keywords
Sarcopenia, Elderly, Outpatient, Exercise, Intervention
Medical subject headings
Sarcopenia, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental groupBehavioural

    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
    1. 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
Study groups in NCT06049914
Study groupRoleWhat they receive
Experimental groupExperimental1. 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
Receives: Behavioral: Experimental group
Control groupNo intervention* 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Screening, 0st week of intervention, 6th week of intervention, 12th week of intervention

Secondary outcomes (9)

  1. Grip strength

    Measure maximum grip strength with a grip dynamometer

    Measured: Screening, 0st week of intervention, 6th week of intervention, 12th week of intervention

  2. Falls

    Falls Survey in Last 3 Months

    Measured: 0st week of intervention, 12th week of intervention, 24th week of intervention

  3. 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.

    Measured: 0st week of intervention, 12th week of intervention

  4. 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.

    Measured: 0st week of intervention, 6th week of intervention, 12th week of intervention, 24th week of intervention

  5. 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.

    Measured: 0st week of intervention, 12th week of intervention

  6. 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.

    Measured: 0st week of intervention, 12th week of intervention

  7. 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).

    Measured: 0st week of intervention, 12th week of intervention

  8. 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.

    Measured: 0st week of intervention, 12th week of intervention, 24th week of intervention

  9. 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.

    Measured: 0st week of intervention, 12th week of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2023
  2. Study start8 Aug 2023
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Model description
12-week combined exercise-nutrition intervention
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
94 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06049914
Sponsor's protocol ID
KHMC-SARC-2023
Status last verified
Sep 2023
First submitted
6 Sep 2023
Last updated
22 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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)

Publications

  • 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.

    PubMed 30498820

  • 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.

    PubMed 30312372

  • 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.

    PubMed 32033882

  • 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.

    PubMed 32743250

  • 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.

    PubMed 28539168

  • 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.

    PubMed 28935775

  • 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.

    PubMed 30462162

  • 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.

    PubMed 30864254

  • 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.

    PubMed 30243898

  • 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.

    PubMed 30486262

  • 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.

    PubMed 10690696

  • 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.

    PubMed 34311098

  • 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.

    PubMed 23851406

  • 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.

    PubMed 39443873

Questions about this trial

What is this clinical trial studying?

A study testing Experimental group in people with Sarcopenia, run by Kyunghee University Medical Center at 3 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Minjin Kim (rhdeo64@naver.com ext. +821030741008, rhdeo64@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

5-time chair stand test (time frame: Screening, 0st week of intervention, 6th week of intervention, 12th week of intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06049914, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.

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