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

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ClinicalTrials.gov Identifier: NCT06049914
Recruitment Status : Recruiting
First Posted : September 22, 2023
Last Update Posted : September 22, 2023
Sponsor:
Information provided by (Responsible Party):
Chang Won Won, Kyunghee University Medical Center

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 12-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 : August 8, 2023
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. Falls [ Time Frame: 0st week of intervention, 12th week of intervention, 24th week of intervention ]
    Falls Survey in Last 3 Months

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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).

  8. 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.

  9. 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.


Eligibility Criteria
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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06049914


Contacts
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Contact: Minjin Kim rhdeo64@naver.com ext +821030741008 rhdeo64@naver.com

Locations
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Korea, Republic of
Dongdong Family Medicine Clinic Recruiting
Dobong, Seoul, Korea, Republic of, 01384
Contact: Jaeuk Baek    +82 10-9904-8803 ext +82 956-0415    tendobaek@hanmail.net   
Dongbu-hanil Surgery Clinic Recruiting
Dobong, Seoul, Korea, Republic of
Contact: Seong Euk Kim    +82 10-9416-7369 ext +82 3492-4754    podobear@hanmail.net   
Seoulbom United Clinic Recruiting
Dobong, Seoul, Korea, Republic of
Contact: Chung Hyeong Lee    +82 10-2534-3302 ext +82 -907-0304    leech98@gmail.com   
Sponsors and Collaborators
Kyunghee University Medical Center
Investigators
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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
More Information
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Publications:

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Responsible Party: Chang Won Won, Principal Investigator, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT06049914    
Other Study ID Numbers: KHMC-SARC-2023
First Posted: September 22, 2023    Key Record Dates
Last Update Posted: September 22, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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)
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
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.
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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chang Won Won, Kyunghee University Medical Center:
Sarcopenia
Elderly
Outpatient
Exercise
Intervention
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
 Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical