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

Primary Purpose

Sarcopenia

Status

Recruiting

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Experimental group

About this trial

This is an interventional screening trial for Sarcopenia focused on measuring Sarcopenia, Elderly, Outpatient, Exercise, Intervention

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept 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

Sites / Locations

Dongdong Family Medicine ClinicRecruiting
Dongbu-hanil Surgery ClinicRecruiting
Seoulbom United ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

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 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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Grip strength

Measure maximum grip strength with a grip dynamometer

Falls

Falls Survey in Last 3 Months

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.

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.

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.

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.

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).

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.

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.

Full Information

NCT ID

NCT06049914

First Posted

September 6, 2023

Last Updated

September 16, 2023

Sponsor

Kyunghee University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT06049914

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 8, 2023 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kyunghee University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcopenia

Keywords

Sarcopenia, Elderly, Outpatient, Exercise, Intervention

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

12-week combined exercise-nutrition intervention

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Experimental group

Intervention Description

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 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

Primary Outcome Measure Information:

Title

5-time chair stand test

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Grip strength

Description

Measure maximum grip strength with a grip dynamometer

Time Frame

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

Title

Falls

Description

Falls Survey in Last 3 Months

Time Frame

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

Title

EuroQol Visual Analogue Scale(EQ-VAS)

Description

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.

Time Frame

0st week of intervention, 12th week of intervention

Title

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

Description

Assess the skills and abilities needed to perform specific daily tasks related to an independent lifestyle in Korean version.

Time Frame

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

Title

Korean version of Physical Activity Scale for the Elderly(K-PASE)

Description

Time Frame

0st week of intervention, 12th week of intervention

Title

Mini Nutritional Assessment(MNA)

Description

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.

Time Frame

0st week of intervention, 12th week of intervention

Title

Korean version of Mini-mental State Examination(K-MMSE)

Description

a set of questions that commonly used to check for cognitive impairment (problems with thinking, communication, understanding and memory).

Time Frame

0st week of intervention, 12th week of intervention

Title

Korean version of Short Form of Geriatric Depression Scale(SGDS-K)

Description

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.

Time Frame

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

Title

The 12-item Health Survey(SF-12)

Description

Self-reported outcome measure assessing the impact of health on an individual's everyday life. It is used as a quality of life measure.

Time Frame

0st week of intervention, 12th week of intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Minjin Kim

Phone

rhdeo64@naver.com

Ext

+821030741008

rhdeo64@naver.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chang Won Won, MD

Organizational Affiliation

Kyunghee University Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ja Euk Baek

Organizational Affiliation

Dongdong Family Medicine Clinic

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Seong Euk Kim

Organizational Affiliation

Dongbu-hanil Surgery Clinic

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Chung Hyeong Lee

Organizational Affiliation

Seoulbom United Clinic

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Mi Ji Kim

Organizational Affiliation

Kyunghee University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Seon Yeong Kim

Organizational Affiliation

Kyunghee University Medical Center

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Jeong Ha Kim

Organizational Affiliation

Chung-Ang University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Jeong Ha Park

Organizational Affiliation

Kyunghee University Medical Center

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Ga Yang Shim

Organizational Affiliation

Kyunghee University Medical Center

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Hye Suk Lee

Organizational Affiliation

Kyunghee University Medical Center

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Dae Hyun Lee

Organizational Affiliation

Kyunghee University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Hee Eun Jung

Organizational Affiliation

Kyunghee University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Jae Young Jang

Organizational Affiliation

Kyunghee University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Na Hyun Lim

Organizational Affiliation

Kyunghee University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Hyun jin Cho

Organizational Affiliation

Kyunghee University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Min JIn Kim

Organizational Affiliation

Kyunghee University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Woohyuk Ji

Organizational Affiliation

Kyunghee University Medical Center

Official's Role

Study Chair

Facility Information:

Facility Name

Dongdong Family Medicine Clinic

City

Dobong

State/Province

Seoul

ZIP/Postal Code

01384

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jaeuk Baek

Phone

+82 10-9904-8803

Ext

+82 956-0415

tendobaek@hanmail.net

Facility Name

Dongbu-hanil Surgery Clinic

City

Dobong

State/Province

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Seong Euk Kim

Phone

+82 10-9416-7369

Ext

+82 3492-4754

podobear@hanmail.net

Facility Name

Seoulbom United Clinic

City

Dobong

State/Province

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chung Hyeong Lee

Phone

+82 10-2534-3302

Ext

+82 -907-0304

leech98@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

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

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