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

Kyung Hee University

Status: Enrolling

Conditions: Sarcopenia

Treatments: Behavioral: Experimental group

Study type: Interventional

Funder types: Other

Identifiers

NCT06049914

KHMC-SARC-2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 estimated patients

Sex: All

Ages: 65 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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94 participants in 2 patient groups

Experimental group

Experimental group

Description:

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

Treatment:

Behavioral: Experimental group

Control group

No Intervention group

Description:

* 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.