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

Sponsor

Kyunghee University Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT06049914

Collaborator

(none)

Enrollment

Locations

Arms

16.8

Anticipated Duration (Months)

31.3

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcopenia	Behavioral: Experimental group	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

94 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

12-week combined exercise-nutrition intervention12-week combined exercise-nutrition intervention

Masking:

Double (Participant, Investigator)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Aug 8, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group 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	Behavioral: Experimental group 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
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.

Arm

Intervention/Treatment

Experimental: Experimental group

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

Behavioral: Experimental group

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

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.

Outcome Measures

Primary Outcome Measures

5-time chair stand test [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 Outcome Measures

Grip strength [Screening, 0st week of intervention, 6th week of intervention, 12th week of intervention]
Measure maximum grip strength with a grip dynamometer
Falls [0st week of intervention, 12th week of intervention, 24th week of intervention]
Falls Survey in Last 3 Months
EuroQol Visual Analogue Scale(EQ-VAS) [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.
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]
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) [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.
Mini Nutritional Assessment(MNA) [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.
Korean version of Mini-mental State Examination(K-MMSE) [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).
Korean version of Short Form of Geriatric Depression Scale(SGDS-K) [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.
The 12-item Health Survey(SF-12) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dongdong Family Medicine Clinic	Dobong	Seoul	Korea, Republic of	01384
2	Dongbu-hanil Surgery Clinic	Dobong	Seoul	Korea, Republic of
3	Seoulbom United Clinic	Dobong	Seoul	Korea, Republic of