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

Kyunghee University Medical Center3 sites in 1 country94 target enrollmentAugust 8, 2023

ConditionsSarcopenia

Overview

Phase: N/A
Intervention: Not specified
Conditions: Sarcopenia
Sponsor: Kyunghee University Medical Center
Enrollment: 94
Locations: 3
Primary Endpoint: 5-time chair stand test
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

August 8, 2023

End Date

December 31, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kyunghee University Medical Center

Responsible Party

Principal Investigator

Chang Won Won

Principal Investigator

Kyunghee University Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

5-time chair stand test

Time Frame: Screening, 0st week of intervention, 6th week of intervention, 12th week of intervention

a test of lower limb function that measures the fastest time taken to stand five times from a chair with arms folded.

Secondary Outcomes

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 Physical Activity Scale for the Elderly(K-PASE)(0st week of intervention, 12th week of intervention)
Korean version of Mini-mental State Examination(K-MMSE)(0st week of intervention, 12th week of intervention)
Grip strength(Screening, 0st week of intervention, 6th week of intervention, 12th week of intervention)
Mini Nutritional Assessment(MNA)(0st week of intervention, 12th week of intervention)
Korean version of Short Form of Geriatric Depression Scale(SGDS-K)(0st week of intervention, 12th week of intervention, 24th 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)
The 12-item Health Survey(SF-12)(0st week of intervention, 12th week of intervention)