Clinical trial NCT06049914: 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
Overall status: RECRUITING
Phase: NA
Conditions: Sarcopenia
Keywords: Sarcopenia
Elderly
Outpatient
Exercise
Intervention
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 94
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 12-week combined exercise-nutrition intervention
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: 5-time chair stand test
timeFrame: Screening, 0st week of intervention, 6th week of intervention, 12th week of intervention
Secondary outcomes:
measure: Grip strength
timeFrame: Screening, 0st week of intervention, 6th week of intervention, 12th week of intervention
measure: Falls
timeFrame: 0st week of intervention, 12th week of intervention, 24th week of intervention
measure: EuroQol Visual Analogue Scale(EQ-VAS)
timeFrame: 0st week of intervention, 12th week of intervention
measure: Korean version of Instrumental Activities of Daily Living (K-IADL)
timeFrame: 0st week of intervention, 6th week of intervention, 12th week of intervention, 24th week of intervention
measure: Korean version of Physical Activity Scale for the Elderly(K-PASE)
timeFrame: 0st week of intervention, 12th week of intervention
measure: Mini Nutritional Assessment(MNA)
timeFrame: 0st week of intervention, 12th week of intervention
measure: Korean version of Mini-mental State Examination(K-MMSE)
timeFrame: 0st week of intervention, 12th week of intervention
measure: Korean version of Short Form of Geriatric Depression Scale(SGDS-K)
timeFrame: 0st week of intervention, 12th week of intervention, 24th week of intervention
measure: The 12-item Health Survey(SF-12)
timeFrame: 0st week of intervention, 12th week of intervention
Other outcomes:
Locations:
city: Dobong
country: Korea, Republic of
facility: Dongdong Family Medicine Clinic
state: Seoul
city: Dobong
country: Korea, Republic of
facility: Dongbu-hanil Surgery Clinic
state: Seoul
city: Dobong
country: Korea, Republic of
facility: Seoulbom United Clinic
state: Seoul
Study officials:
affiliation: Kyunghee University Medical Center
name: Chang Won Won, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dongdong Family Medicine Clinic
name: Ja Euk Baek
role: STUDY_DIRECTOR
affiliation: Dongbu-hanil Surgery Clinic
name: Seong Euk Kim
role: STUDY_DIRECTOR
affiliation: Seoulbom United Clinic
name: Chung Hyeong Lee
role: STUDY_DIRECTOR
affiliation: Kyunghee University
name: Mi Ji Kim
role: STUDY_DIRECTOR
affiliation: Kyunghee University Medical Center
name: Seon Yeong Kim
role: STUDY_DIRECTOR
affiliation: Chung-Ang University
name: Jeong Ha Kim
role: STUDY_DIRECTOR
affiliation: Kyunghee University Medical Center
name: Jeong Ha Park
role: STUDY_DIRECTOR
affiliation: Kyunghee University Medical Center
name: Ga Yang Shim
role: STUDY_DIRECTOR
affiliation: Kyunghee University Medical Center
name: Hye Suk Lee
role: STUDY_CHAIR
affiliation: Kyunghee University
name: Dae Hyun Lee
role: STUDY_CHAIR
affiliation: Kyunghee University
name: Hee Eun Jung
role: STUDY_CHAIR
affiliation: Kyunghee University
name: Jae Young Jang
role: STUDY_CHAIR
affiliation: Kyunghee University
name: Na Hyun Lim
role: STUDY_CHAIR
affiliation: Kyunghee University
name: Hyun jin Cho
role: STUDY_CHAIR
affiliation: Kyunghee University
name: Min JIn Kim
role: STUDY_CHAIR
affiliation: Kyunghee University Medical Center
name: Woohyuk Ji
role: STUDY_CHAIR
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