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

September 16, 2023 updated by: Chang Won Won, Kyunghee University Medical Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Minjin Kim
  • Phone Number: +821030741008 rhdeo64@naver.com
  • Email: rhdeo64@naver.com

Study Locations

  • Korea, Republic of
    • Seoul
      • Dobong, Seoul, Korea, Republic of, 01384
        • Recruiting
        • Dongdong Family Medicine Clinic
        • Contact:
      • Dobong, Seoul, Korea, Republic of
        • Recruiting
        • Dongbu-hanil Surgery Clinic
        • Contact:
      • Dobong, Seoul, Korea, Republic of
        • Recruiting
        • Seoulbom United Clinic
        • Contact:
          • Chung Hyeong Lee
          • Phone Number: +82 -907-0304 +82 10-2534-3302
          • Email: leech98@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group

  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

  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
No Intervention: Control group
  • 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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Screening, 0st week of intervention, 6th week of intervention, 12th week of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grip strength
Time Frame: Screening, 0st week of intervention, 6th week of intervention, 12th week of intervention
Measure maximum grip strength with a grip dynamometer
Screening, 0st week of intervention, 6th week of intervention, 12th week of intervention
Falls
Time Frame: 0st week of intervention, 12th week of intervention, 24th week of intervention
Falls Survey in Last 3 Months
0st week of intervention, 12th week of intervention, 24th week of intervention
EuroQol Visual Analogue Scale(EQ-VAS)
Time Frame: 0st week of intervention, 12th week of intervention
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
Korean version of Instrumental Activities of Daily Living (K-IADL)
Time Frame: 0st week of intervention, 6th week of intervention, 12th week of intervention, 24th week of intervention
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
Korean version of Physical Activity Scale for the Elderly(K-PASE)
Time Frame: 0st week of intervention, 12th week of intervention
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
Mini Nutritional Assessment(MNA)
Time Frame: 0st week of intervention, 12th week of intervention
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
Korean version of Mini-mental State Examination(K-MMSE)
Time Frame: 0st week of intervention, 12th week of intervention
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
Korean version of Short Form of Geriatric Depression Scale(SGDS-K)
Time Frame: 0st week of intervention, 12th week of intervention, 24th week of intervention
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
The 12-item Health Survey(SF-12)
Time Frame: 0st week of intervention, 12th week of intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyunghee University Medical Center

Investigators

  • Principal Investigator: Chang Won Won, MD, Kyunghee University Medical Center
  • Study Director: 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 Chair: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

September 6, 2023

First Submitted That Met QC Criteria

September 16, 2023

First Posted (Actual)

September 22, 2023

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 16, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KHMC-SARC-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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)

IPD Sharing 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.

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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