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

NCT06049914 | Unknown

• 1 other identifier: KHMC-SARC-2023
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Sarcopenia

Keywords

Sarcopenia; Elderly; Outpatient; Exercise; Intervention

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (9)

• Grip strength

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

• Falls

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

• EuroQol Visual Analogue Scale(EQ-VAS)

  0st week of intervention, 12th week of intervention

• Korean version of Instrumental Activities of Daily Living (K-IADL)

  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)

  0st week of intervention, 12th week of intervention

Study Arms (2)

Experimental group

EXPERIMENTAL

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

NO 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.

Interventions

Experimental group BEHAVIORAL

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

Experimental group

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)
• \[(1) and {(2) or (3)}\]

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyunghee University Medical Center: lead

Study Sites (3)

Dongdong Family Medicine Clinic

Dobong, Seoul, 01384, South Korea

RECRUITING

Dongbu-hanil Surgery Clinic

Dobong, Seoul, South Korea

RECRUITING

Seoulbom United Clinic

Dobong, Seoul, South Korea

RECRUITING

Related Publications (14)

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  PMID: 30498820 BACKGROUND

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  PMID: 23851406 BACKGROUND

• 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.

  PMID: 39443873 DERIVED

MeSH Terms

Conditions

Sarcopenia; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Study Officials

• Chang Won Won, MD

  Kyunghee University Medical Center

  PRINCIPAL INVESTIGATOR

• Ja Euk Baek

  Dongdong Family Medicine Clinic

  STUDY DIRECTOR

• Seong Euk Kim

  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

Central Study Contacts

Minjin Kim

CONTACT

rhdeo64@naver.com; rhdeo64@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 12-week combined exercise-nutrition intervention

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 22, 2023
• Study Start: August 8, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 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.
• Access Criteria: 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

Locations

KR (3)