SarcopeniaNCT07492849
Prevalence of Sarcopenia in Stroke Patients
An observational study of Sarcopenia and Cerebral Stroke, run by Cishan Hospital, Ministry of Health and Welfare at 1 site in Taiwan.
Trial summary
The goal of this observational study is to analyze the characteristics of sarcopenia-related variables in post-acute and chronic stroke patients using various clinical measurement tools. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Sarcopenia, Cerebral Stroke, Cerebral Vascular Accident (CVA)/Stroke
- What is being tested?
- Objective assessments and Subjective assessment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 May 2025to 1 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged over 40 years who have been diagnosed with stroke. Diagnosis is defined as made by a relevant specialist and documented in the Cishan Hospital medical record system, with a corresponding International Classification of Diseases, 10th Revision (ICD-10) code. Both ischemic and hemorrhagic strokes are included.
Who may be able to join
- Both ischemic and hemorrhagic strokes are included. 1.1 Definition of chronic stroke patients (Group 1): Patients whose last stroke occurred more than one year prior.
- 1.2 Definition of post-acute care (PAC) stroke patients (Group 2): Patients whose last stroke occurred at least 14 days prior, have been assessed by a neurologist as eligible for transfer to the PAC program, and are admitted to a PAC ward.
- Patients with sufficient cognitive and physical ability to complete sarcopenia-related assessments (e.g., body composition, grip strength, walking speed) and the Mini Nutritional Assessment, as judged by the principal investigator.
- Patients who provide informed consent after being fully informed. 3.1 Group 1 (chronic stroke patients): Consent must be obtained directly from the patient.
- 3.2 Group 2 (PAC stroke patients): If the patient has cognitive impairment during the PAC phase, consent may be obtained from a family member or legal representative after they have been fully informed. -
Who cannot join
- Patients with lower limb neurological, muscular, or skeletal injuries or disorders within six months prior to enrollment.
- Patients with severe cardiopulmonary diseases or other neurological conditions requiring oxygen therapy.
- Patients who, within one month prior to the study, have experienced major infections requiring hospitalization and antibiotic administration or other major illnesses requiring invasive treatment (e.g., cardiac catheterization). -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence and Associated Factors of Sarcopenia in Stroke Patients: A Cross-Sectional Observational Study
The goal of this observational study is to analyze the characteristics of sarcopenia-related variables in post-acute and chronic stroke patients using various clinical measurement tools. The study also aims to examine the differences in these variables based on age groups (40-65 years and >65 years), sex, and stroke severity.
The main questions it aims to answer are:
Read more
What are the differences in sarcopenia prevalence and related indicators between post-acute care and chronic stroke patients? How do age, sex, and stroke severity affect these sarcopenia-related measurements?
Participants will include stroke patients aged 40 and older with adequate cognitive and physical function to complete sarcopenia screening and questionnaires. They will be divided into two groups:
Group 1: Chronic stroke patients (n ≥ 75) Group 2: Post-acute care stroke patients (n ≥ 25)
All participants will undergo both objective and subjective assessments, including:
Objective assessments: Body composition, quadriceps strength, quadriceps and gastrocnemius muscle thickness via ultrasound, calf circumference, dominant hand grip strength, walking speed, SARC-F questionnaire, and the Mini Nutritional Assessment.
Subjective assessment: EQ-5D health-related quality of life questionnaire. The collected data will be analyzed to compare the prevalence and characteristics of sarcopenia between the two stroke groups and across different subgroups by age and sex.
Read the detailed description
Study Objectives Sarcopenia is a progressive disease characterized by the loss of muscle mass and decline in muscle function, with a prevalence exceeding 20% among the elderly population aged 65 years and older in Taiwan. The deterioration of muscle mass and functional performance eventually leads to adverse health outcomes, including increased risk of mortality. Apart from aging, the etiology of sarcopenia involves various factors such as nutrition, physical activity, and underlying diseases. Stroke is one of the leading causes of death and disability both in Taiwan and globally. In recent years, the population of post-stroke survivors has been aging rapidly, with a trend toward earlier onset of first-ever strokes.
"Stroke-related sarcopenia" refers to sarcopenia induced by stroke or an exacerbation of pre-existing sarcopenia, which negatively impacts clinical outcomes in stroke patients. Previous studies have investigated sarcopenia-related measures in stroke survivors, such as handgrip strength and calf circumference; however, these studies often utilized a single approach. To the best of our knowledge, no comprehensive analysis of these sarcopenia-related variables has been conducted. Furthermore, muscle strength in humans begins to decline around the age of 40, and this physiological deterioration may differ by sex. Limited research has compared the various sarcopenia indicators between post-acute care (PAC) and chronic stroke patients.
The objectives of this study are as follows:
To analyze the characteristics of sarcopenia-related variables assessed using different clinical measurement tools in post-acute and chronic stroke patients.
To examine the characteristics of these variables across different age groups (40-65 years and >65 years), sexes, and stroke severity levels.
Expected Outcomes The prevalence of sarcopenia in both post-acute and chronic stroke patients is anticipated to be higher than that in the general elderly community.
Chronic stroke patients are expected to exhibit a slightly higher prevalence of sarcopenia compared to post-acute care stroke patients.
Older stroke patients (>65 years) are expected to have a higher prevalence of sarcopenia compared to younger stroke patients (40-65 years).
Methods
This study is designed as a cross-sectional observational study and will be conducted at the Ministry of Health and Welfare Qishan Hospital. Participants will include stroke patients aged 40 years or older who have sufficient cognitive and physical abilities to complete sarcopenia screening and related questionnaires. Participants will be divided into two groups:
Group 1: Chronic stroke patients (n ≥ 75) Group 2: Stroke patients recently admitted to post-acute care wards (n ≥ 25) The recruitment will follow a 3:1 allocation ratio.
All participants will undergo both objective and subjective assessments:
Objective assessments: Sarcopenia-related indicators, including body composition, quadriceps strength, muscle thickness of the quadriceps and gastrocnemius via ultrasound, calf circumference, dominant hand grip strength, walking speed, the SARC-F questionnaire, and the Mini Nutritional Assessment.
Subjective assessment: EQ-5D questionnaire to evaluate health-related quality of life.
After data collection, the data will be entered and analyzed statistically to compare the prevalence and characteristics of sarcopenia between different stroke populations (post-acute care vs. chronic stroke; older vs. younger stroke patients).
- Being tested
- Objective assessments, Subjective assessment
- Keywords
- stroke, sarcopenia, Appendicular Skeletal Muscle Mass, Mini Nutritional Assessment, Post-Acute Care
- Medical subject headings
- Sarcopenia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Objective assessmentsDiagnostic test
include sarcopenia-related indicators such as body composition, quadriceps muscle strength measurement, quadriceps muscle thickness via ultrasound, gastrocnemius muscle thickness via ultrasound, calf circumference, dominant hand grip strength, walking speed, the SARC-F questionnaire, and the Mini Nutritional Assessment scale.
Subjective assessmentDiagnostic test
involves the EQ-5D questionnaire to evaluate health-related quality of life
| Study group | Role | What they receive |
|---|---|---|
| Post-acute stroke patients | a stroke diagnosis made by a relevant specialist and documented in the medical record system of Cishan Hospital, with the corresponding International Classification of Diseases, 10th Revision (ICD-10) code. Both ischemic and hemorrhagic strokes are included.
Definition of post-acute care (PAC) stroke patients: Patients whose last stroke occurred at least 14 days prior, who have been assessed by a neurologist as eligible for transfer to the PAC program, and who are admitted to the PAC ward. Receives: Diagnostic Test: Objective assessments; Diagnostic Test: Subjective assessment | |
| Chronic stroke patients | a stroke diagnosis made by a relevant specialist and documented in the medical record system of Cishan Hospital, with the corresponding International Classification of Diseases, 10th Revision (ICD-10) code. Both ischemic and hemorrhagic strokes are included.
Definition of chronic stroke patients (Group 1): Patients whose last stroke occurred more than 6 months prior. Receives: Diagnostic Test: Objective assessments; Diagnostic Test: Subjective assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appendicular Skeletal Muscle Mass Index
ASMMI is defined as appendicular skeletal muscle mass(kg)/height (m^2). This study utilizes BIA for body muscle mass measurement, considering the accessibility of the equipment and budget constraints.
Measured: at enrollment
Handgrip strength
In this study, grip strength is measured using a JAMAR electronic dynamometer, with a minimum scale of 0.1 pounds. The testing procedure is as follows:
The participant is seated with the shoulder in a neutral position, the upper arm relaxed alongside the body, and the elbow flexed at a 90-degree angle. The participant holds the JAMAR dynamometer with their dominant hand. They are instructed to gradually apply force, reaching their maximum grip strength within 3 seconds.
Before the test, a practice trial is provided to ensure the participant understands the procedure. The grip strength is tested twice, with a 30-second rest between trials. The average of the two trials is recorded as the final result
Measured: at enrollment
Gait speed
The testing procedure is as follows: A stopwatch is used to measure the time (in seconds) from the command "Ready, go" until the participant crosses a 6-meter distance marked on the floor. Two trials are conducted, with a 10-minute rest between each trial. Walking speed (m/s) is calculated for each trial, and the average of the two trials is used for data analysis.
Measured: at enrollment
Secondary outcomes (8)
maximal voluntary isometric contraction of quadriceps
In this study, the maximal voluntary isometric contraction (MVIC) strength of the dominant quadriceps muscle is measured using the MicroFET3 device (Hoggan, Health Industrial, UT, USA) under standardized posture. The average of two measurements is recorded as the participant's MVIC strength.
Measured: at enrollment
Sonographic thickness of quadriceps muscle
In this study, a portable ultrasound device, equipped with a 12 MHz linear probe, is used for measurements. All measurements are performed under the same parameter settings by a physician with years of clinical ultrasound experience.
The measurement of the quadriceps muscle is conducted with participants in a supine position, with both lower limbs extended and fully relaxed. The probe is placed at the midpoint of the line connecting the anterior superior iliac spine (ASIS) and the superior border of the patella (see illustration on the left). The thickness of the quadriceps muscle is defined as the sum of the thickness of the rectus femoris and vastus intermedius muscles, measured in a transverse scan.
Measured: at enrollment
Sonographic thickness of gastrocnemius muscle
In this study, a portable ultrasound device, equipped with a 12 MHz linear probe, is used for measurements. All measurements are performed under the same parameter settings by a physician with years of clinical ultrasound experience.
The measurement of the gastrocnemius muscle is performed with participants in a prone position, both legs extended and relaxed, with the feet hanging off the edge of the examination table. The examiner places the ultrasound probe close to the skin, ensuring the probe beam is perpendicular to the skin surface. The medial cross-sectional area of the medial head of the gastrocnemius muscle is identified, with the largest cross-sectional area selected as the standard imaging plane, and the corresponding skin surface location is marked.
Measurements include:
- Fat thickness (FT): The distance from the superficial fascia to the skin.
- Muscle thickness (MT): The distance from the superficial fascia to the deep fascia.
Measured: at enrollment
Calf Circumference
The measurement of calf circumference (CC) is conducted bilaterally, including the paretic and non-paretic sides of stroke patients. Participants are positioned in either a seated or supine posture, with the knees and hips flexed at 90°, and the feet naturally placed on the floor or bed, with the ankles relaxed. The examiner faces the participant and identifies the largest circumference of the calf on both sides.
A flexible tape measure is used to measure CC, ensuring it is positioned perpendicular to the axis of the calf. The measurement error is kept below 0.1 cm. To minimize the influence of edema, measurements are performed in the morning. Each leg is measured twice, and the highest value is recorded.
Measured: at enrollment
Sarcopenia risk assessed by the Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls (SARC-F) questionnaire
Sarcopenia risk was assessed using the Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls (SARC-F) questionnaire, a 5-item screening tool based on participant self-reported responses. Each item is scored from 0 to 2, with a total score ranging from 0 to 10.
Higher scores indicate a greater risk of sarcopenia, and a score ≥4 suggests probable sarcopenia. The SARC-F questionnaire is designed for use in clinical and community settings without requiring specialized equipment, making it suitable for large-scale screening.
The total SARC-F score was analyzed as a continuous variable.
Measured: at enrollment
Mini Nutritional Assessment
Nutritional status was assessed using the Mini Nutritional Assessment (MNA), an 18-item standardized tool evaluating dietary intake, anthropometric measurements, and general health status. The total score ranges from 0 to 30.
Based on established cutoffs, scores ≥24 indicate normal nutritional status, scores between 17 and 23.5 indicate risk of malnutrition, and scores <17 indicate malnutrition.
The total MNA score was analyzed as a continuous variable.
Measured: at enrollment
Health-related quality of life assessed by the EuroQol 5-Dimension 3-Level (EQ-5D-3L) index score
Health-related quality of life was assessed using the EuroQol 5-Dimension 3-Level (EQ-5D-3L) questionnaire, which evaluates five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
An EQ-5D index score was calculated using the Taiwan-specific value set. The index score ranges from -0.111 to 1.000, with higher scores indicating better health-related quality of life.
The EQ-5D index score was analyzed as a continuous variable.
Measured: at enrollment
Health-related quality of life assessed by the EuroQol 5-DimensionVisual Analogue Scale (EQ-5D-VAS)
EQ-5D-VAS, in which participants rate their overall health status on a scale from 0 to 100.
A score of 0 represents the worst imaginable health state, and a score of 100 represents the best imaginable health state.
The EQ-5D VAS score was analyzed as a continuous variable, with higher scores indicating better perceived health status.
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start5 May 2025
- Primary completion4 Oct 2025
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cishan Hospital, Ministry of Health and Welfare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Hui Tuan, Cishan Hospital, Ministry of Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492849
- Sponsor's protocol ID
- CHIS11402
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nozoe M, Kanai M, Kubo H, Yamamoto M, Shimada S, Mase K. Prestroke sarcopenia and functional outcomes in elderly patients who have had an acute stroke: A prospective cohort study. Nutrition. 2019 Oct;66:44-47. doi: 10.1016/j.nut.2019.04.011. Epub 2019 Apr 25.
PubMed 31207438Shimizu A, Fujishima I, Maeda K, Murotani K, Ohno T, Nomoto A, Nagami S, Nagano A, Sato K, Ueshima J, Inoue T, Shimizu M, Ishida Y, Kayashita J, Suenaga M, Mori N. Association between food texture levels consumed and the prevalence of malnutrition and sarcopenia in older patients after stroke. Eur J Clin Nutr. 2022 Nov;76(11):1576-1582. doi: 10.1038/s41430-022-01126-1. Epub 2022 Apr 13.
PubMed 35418607Kanai M, Nozoe M, Ohtsubo T, Yasumoto I, Ueno K. Relationship of Functional Outcome With Sarcopenia and Objectively Measured Physical Activity in Patients With Stroke Undergoing Rehabilitation. J Aging Phys Act. 2022 Apr 23;31(1):1-6. doi: 10.1123/japa.2022-0025. Print 2023 Feb 1.
PubMed 35461188Lee H, Lee IH, Heo J, Baik M, Park H, Lee HS, Nam HS, Kim YD. Impact of Sarcopenia on Functional Outcomes Among Patients With Mild Acute Ischemic Stroke and Transient Ischemic Attack: A Retrospective Study. Front Neurol. 2022 Mar 15;13:841945. doi: 10.3389/fneur.2022.841945. eCollection 2022.
PubMed 35370897Abe T, Yoshimua Y, Imai R, Sato Y. A Combined Assessment Method of Phase Angle and Skeletal Muscle Index to Better Predict Functional Recovery after Acute Stroke. J Nutr Health Aging. 2022;26(5):445-451. doi: 10.1007/s12603-022-1777-9.
PubMed 35587756Scherbakov N, von Haehling S, Anker SD, Dirnagl U, Doehner W. Stroke induced Sarcopenia: muscle wasting and disability after stroke. Int J Cardiol. 2013 Dec 10;170(2):89-94. doi: 10.1016/j.ijcard.2013.10.031. Epub 2013 Oct 14.
PubMed 24231058Scherbakov N, Sandek A, Doehner W. Stroke-related sarcopenia: specific characteristics. J Am Med Dir Assoc. 2015 Apr;16(4):272-6. doi: 10.1016/j.jamda.2014.12.007. Epub 2015 Feb 10.
PubMed 25676847Sennfalt S, Norrving B, Petersson J, Ullberg T. Long-Term Survival and Function After Stroke: A Longitudinal Observational Study From the Swedish Stroke Register. Stroke. 2019 Jan;50(1):53-61. doi: 10.1161/STROKEAHA.118.022913. Epub 2018 Dec 7.
PubMed 30580719Toyoda K, Yoshimura S, Nakai M, Koga M, Sasahara Y, Sonoda K, Kamiyama K, Yazawa Y, Kawada S, Sasaki M, Terasaki T, Miwa K, Koge J, Ishigami A, Wada S, Iwanaga Y, Miyamoto Y, Minematsu K, Kobayashi S; Japan Stroke Data Bank Investigators. Twenty-Year Change in Severity and Outcome of Ischemic and Hemorrhagic Strokes. JAMA Neurol. 2022 Jan 1;79(1):61-69. doi: 10.1001/jamaneurol.2021.4346.
PubMed 34870689Martone AM, Bianchi L, Abete P, Bellelli G, Bo M, Cherubini A, Corica F, Di Bari M, Maggio M, Manca GM, Marzetti E, Rizzo MR, Rossi A, Volpato S, Landi F. The incidence of sarcopenia among hospitalized older patients: results from the Glisten study. J Cachexia Sarcopenia Muscle. 2017 Dec;8(6):907-914. doi: 10.1002/jcsm.12224. Epub 2017 Sep 14.
PubMed 28913934Lo YC, Wahlqvist ML, Huang YC, Chuang SY, Wang CF, Lee MS. Medical costs of a low skeletal muscle mass are modulated by dietary diversity and physical activity in community-dwelling older Taiwanese: a longitudinal study. Int J Behav Nutr Phys Act. 2017 Mar 14;14(1):31. doi: 10.1186/s12966-017-0487-x.
PubMed 28288651Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.
PubMed 32033882Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.
PubMed 20392703Cruz-Jentoft AJ, Sayer AA. Sarcopenia. Lancet. 2019 Jun 29;393(10191):2636-2646. doi: 10.1016/S0140-6736(19)31138-9. Epub 2019 Jun 3.
PubMed 31171417
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Associated Factors of Sarcopenia in Stroke Patients: A Cross-Sectional Observational Study
- ClinicalTrials.gov ID
- NCT07492849
- Acronym / sponsor ID
- CHIS11402
- Keywords
- stroke, sarcopenia, Appendicular Skeletal Muscle Mass, Mini Nutritional Assessment, Post-Acute Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cishan Hospital, Ministry of Health and WelfareUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- 4 Oct 2025 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to analyze the characteristics of sarcopenia-related variables in post-acute and chronic stroke patients using various clinical measurement tools. The study also aims to examine the differences in these variables based on age groups (40-65 years and >65 years), sex, and stroke severity.
The main questions it aims to answer are:
What are the differences in sarcopenia prevalence and related indicators between post-acute care and chronic stroke patients? How do age, sex, and stroke severity affect these sarcopenia-related measurements?
Participants will include stroke patients aged 40 and older with adequate cognitive and physical function to complete sarcopenia screening and questionnaires. They will be divided into two groups:
Group 1: Chronic stroke patients (n ≥ 75) Group 2: Post-acute care stroke patients (n ≥ 25)
All participants will undergo both objective and subjective assessments, including:
Objective assessments: Body composition, quadriceps strength, quadriceps and gastrocnemius muscle thickness via ultrasound, calf circumference, dominant hand grip strength, walking speed, SARC-F questionnaire, and the Mini Nutritional Assessment.
Subjective assessment: EQ-5D health-related quality of life questionnaire. The collected data will be analyzed to compare the prevalence and characteristics of sarcopenia between the two stroke groups and across different subgroups by age and sex.
Detailed description
Study Objectives Sarcopenia is a progressive disease characterized by the loss of muscle mass and decline in muscle function, with a prevalence exceeding 20% among the elderly population aged 65 years and older in Taiwan. The deterioration of muscle mass and functional performance eventually leads to adverse health outcomes, including increased risk of mortality. Apart from aging, the etiology of sarcopenia involves various factors such as nutrition, physical activity, and underlying diseases. Stroke is one of the leading causes of death and disability both in Taiwan and globally. In recent years, the population of post-stroke survivors has been aging rapidly, with a trend toward earlier onset of first-ever strokes.
"Stroke-related sarcopenia" refers to sarcopenia induced by stroke or an exacerbation of pre-existing sarcopenia, which negatively impacts clinical outcomes in stroke patients. Previous studies have investigated sarcopenia-related measures in stroke survivors, such as handgrip strength and calf circumference; however, these studies often utilized a single approach. To the best of our knowledge, no comprehensive analysis of these sarcopenia-related variables has been conducted. Furthermore, muscle strength in humans begins to decline around the age of 40, and this physiological deterioration may differ by sex. Limited research has compared the various sarcopenia indicators between post-acute care (PAC) and chronic stroke patients.
The objectives of this study are as follows:
To analyze the characteristics of sarcopenia-related variables assessed using different clinical measurement tools in post-acute and chronic stroke patients.
To examine the characteristics of these variables across different age groups (40-65 years and >65 years), sexes, and stroke severity levels.
Expected Outcomes The prevalence of sarcopenia in both post-acute and chronic stroke patients is anticipated to be higher than that in the general elderly community.
Chronic stroke patients are expected to exhibit a slightly higher prevalence of sarcopenia compared to post-acute care stroke patients.
Older stroke patients (>65 years) are expected to have a higher prevalence of sarcopenia compared to younger stroke patients (40-65 years).
Methods
This study is designed as a cross-sectional observational study and will be conducted at the Ministry of Health and Welfare Qishan Hospital. Participants will include stroke patients aged 40 years or older who have sufficient cognitive and physical abilities to complete sarcopenia screening and related questionnaires. Participants will be divided into two groups:
Group 1: Chronic stroke patients (n ≥ 75) Group 2: Stroke patients recently admitted to post-acute care wards (n ≥ 25) The recruitment will follow a 3:1 allocation ratio.
All participants will undergo both objective and subjective assessments:
Objective assessments: Sarcopenia-related indicators, including body composition, quadriceps strength, muscle thickness of the quadriceps and gastrocnemius via ultrasound, calf circumference, dominant hand grip strength, walking speed, the SARC-F questionnaire, and the Mini Nutritional Assessment.
Subjective assessment: EQ-5D questionnaire to evaluate health-related quality of life.
After data collection, the data will be entered and analyzed statistically to compare the prevalence and characteristics of sarcopenia between different stroke populations (post-acute care vs. chronic stroke; older vs. younger stroke patients).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-acute stroke patients | – | Diagnostic Test: Objective assessments, Diagnostic Test: Subjective assessmenta stroke diagnosis made by a relevant specialist and documented in the medical record system of Cishan Hospital, with the corresponding International Classification of Diseases, 10th Revision (ICD-10) code. Both ischemic and hemorrhagic strokes are included. Definition of post-acute care (PAC) stroke patients: Patients whose last stroke occurred at least 14 days prior, who have been assessed by a neurologist as eligible for transfer to the PAC program, and who are admitted to the PAC ward. |
| Chronic stroke patients | – | Diagnostic Test: Objective assessments, Diagnostic Test: Subjective assessmenta stroke diagnosis made by a relevant specialist and documented in the medical record system of Cishan Hospital, with the corresponding International Classification of Diseases, 10th Revision (ICD-10) code. Both ischemic and hemorrhagic strokes are included. Definition of chronic stroke patients (Group 1): Patients whose last stroke occurred more than 6 months prior. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged over 40 years who have been diagnosed with stroke. Diagnosis is defined as made by a relevant specialist and documented in the Cishan Hospital medical record system, with a corresponding International Classification of Diseases, 10th Revision (ICD-10) code. Both ischemic and hemorrhagic strokes are included.
Key inclusion criteria (5 listed)
- Both ischemic and hemorrhagic strokes are included. 1.1 Definition of chronic stroke patients (Group 1): Patients whose last stroke occurred more than one year prior.
- 1.2 Definition of post-acute care (PAC) stroke patients (Group 2): Patients whose last stroke occurred at least 14 days prior, have been assessed by a neurologist as eligible for transfer to the PAC program, and are admitted to a PAC ward.
- Patients with sufficient cognitive and physical ability to complete sarcopenia-related assessments (e.g., body composition, grip strength, walking speed) and the Mini Nutritional Assessment, as judged by the principal investigator.
- Patients who provide informed consent after being fully informed. 3.1 Group 1 (chronic stroke patients): Consent must be obtained directly from the patient.
- 3.2 Group 2 (PAC stroke patients): If the patient has cognitive impairment during the PAC phase, consent may be obtained from a family member or legal representative after they have been fully informed. -
Key exclusion criteria (3 listed)
- Patients with lower limb neurological, muscular, or skeletal injuries or disorders within six months prior to enrollment.
- Patients with severe cardiopulmonary diseases or other neurological conditions requiring oxygen therapy.
- Patients who, within one month prior to the study, have experienced major infections requiring hospitalization and antibiotic administration or other major illnesses requiring invasive treatment (e.g., cardiac catheterization). -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Objective assessmentsinclude sarcopenia-related indicators such as body composition, quadriceps muscle strength measurement, quadriceps muscle thickness via ultrasound, gastrocnemius muscle thickness via ultrasound, calf circumference, dominant hand grip strength, walking speed, the SARC-F questionnaire, and the Mini Nutritional Assessment scale. | Diagnostic test | Chronic stroke patients, Post-acute stroke patients |
| Subjective assessmentinvolves the EQ-5D questionnaire to evaluate health-related quality of life | Diagnostic test | Chronic stroke patients, Post-acute stroke patients |
Primary outcome
Appendicular Skeletal Muscle Mass Index
Time frame: at enrollment
ASMMI is defined as appendicular skeletal muscle mass(kg)/height (m^2). This study utilizes BIA for body muscle mass measurement, considering the accessibility of the equipment and budget constraints.
Handgrip strength
Time frame: at enrollment
In this study, grip strength is measured using a JAMAR electronic dynamometer, with a minimum scale of 0.1 pounds. The testing procedure is as follows: The participant is seated with the shoulder in a neutral position, the upper arm relaxed alongside the body, and the elbow flexed at a 90-degree angle. The participant holds the JAMAR dynamometer with their dominant hand. They are instructed to gradually apply force, reaching their maximum grip strength within 3 seconds. Before the test, a practice trial is provided to ensure the participant understands the procedure. The grip strength is tested twice, with a 30-second rest between trials. The average of the two trials is recorded as the final result
Gait speed
Time frame: at enrollment
The testing procedure is as follows: A stopwatch is used to measure the time (in seconds) from the command "Ready, go" until the participant crosses a 6-meter distance marked on the floor. Two trials are conducted, with a 10-minute rest between each trial. Walking speed (m/s) is calculated for each trial, and the average of the two trials is used for data analysis.
8 secondary outcomes
maximal voluntary isometric contraction of quadriceps
Time frame: at enrollment
Sonographic thickness of quadriceps muscle
Time frame: at enrollment
Sonographic thickness of gastrocnemius muscle
Time frame: at enrollment
Calf Circumference
Time frame: at enrollment
Sarcopenia risk assessed by the Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls (SARC-F) questionnaire
Time frame: at enrollment
Mini Nutritional Assessment
Time frame: at enrollment
Health-related quality of life assessed by the EuroQol 5-Dimension 3-Level (EQ-5D-3L) index score
Time frame: at enrollment
Health-related quality of life assessed by the EuroQol 5-DimensionVisual Analogue Scale (EQ-5D-VAS)
Time frame: at enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Results publication: PubMed 31207438Nozoe M, Kanai M, Kubo H, Yamamoto M, Shimada S, Mase K. Prestroke sarcopenia and functional outcomes in elderly patients who have had an acute stroke: A prospective cohort study. Nutrition. 2019 Oct;66:44-47. doi: 10.1016/j.nut.2019.04.011. Epub 2019 Apr 25.
- Results publication: PubMed 35418607Shimizu A, Fujishima I, Maeda K, Murotani K, Ohno T, Nomoto A, Nagami S, Nagano A, Sato K, Ueshima J, Inoue T, Shimizu M, Ishida Y, Kayashita J, Suenaga M, Mori N. Association between food texture levels consumed and the prevalence of malnutrition and sarcopenia in older patients after stroke. Eur J Clin Nutr. 2022 Nov;76(11):1576-1582. doi: 10.1038/s41430-022-01126-1. Epub 2022 Apr 13.
- Results publication: PubMed 35461188Kanai M, Nozoe M, Ohtsubo T, Yasumoto I, Ueno K. Relationship of Functional Outcome With Sarcopenia and Objectively Measured Physical Activity in Patients With Stroke Undergoing Rehabilitation. J Aging Phys Act. 2022 Apr 23;31(1):1-6. doi: 10.1123/japa.2022-0025. Print 2023 Feb 1.
- Results publication: PubMed 35370897Lee H, Lee IH, Heo J, Baik M, Park H, Lee HS, Nam HS, Kim YD. Impact of Sarcopenia on Functional Outcomes Among Patients With Mild Acute Ischemic Stroke and Transient Ischemic Attack: A Retrospective Study. Front Neurol. 2022 Mar 15;13:841945. doi: 10.3389/fneur.2022.841945. eCollection 2022.
- Results publication: PubMed 35587756Abe T, Yoshimua Y, Imai R, Sato Y. A Combined Assessment Method of Phase Angle and Skeletal Muscle Index to Better Predict Functional Recovery after Acute Stroke. J Nutr Health Aging. 2022;26(5):445-451. doi: 10.1007/s12603-022-1777-9.
- Results publication: PubMed 24231058Scherbakov N, von Haehling S, Anker SD, Dirnagl U, Doehner W. Stroke induced Sarcopenia: muscle wasting and disability after stroke. Int J Cardiol. 2013 Dec 10;170(2):89-94. doi: 10.1016/j.ijcard.2013.10.031. Epub 2013 Oct 14.
- Results publication: PubMed 25676847Scherbakov N, Sandek A, Doehner W. Stroke-related sarcopenia: specific characteristics. J Am Med Dir Assoc. 2015 Apr;16(4):272-6. doi: 10.1016/j.jamda.2014.12.007. Epub 2015 Feb 10.
- Results publication: PubMed 30580719Sennfalt S, Norrving B, Petersson J, Ullberg T. Long-Term Survival and Function After Stroke: A Longitudinal Observational Study From the Swedish Stroke Register. Stroke. 2019 Jan;50(1):53-61. doi: 10.1161/STROKEAHA.118.022913. Epub 2018 Dec 7.
- Results publication: PubMed 34870689Toyoda K, Yoshimura S, Nakai M, Koga M, Sasahara Y, Sonoda K, Kamiyama K, Yazawa Y, Kawada S, Sasaki M, Terasaki T, Miwa K, Koge J, Ishigami A, Wada S, Iwanaga Y, Miyamoto Y, Minematsu K, Kobayashi S; Japan Stroke Data Bank Investigators. Twenty-Year Change in Severity and Outcome of Ischemic and Hemorrhagic Strokes. JAMA Neurol. 2022 Jan 1;79(1):61-69. doi: 10.1001/jamaneurol.2021.4346.
- Results publication: PubMed 28913934Martone AM, Bianchi L, Abete P, Bellelli G, Bo M, Cherubini A, Corica F, Di Bari M, Maggio M, Manca GM, Marzetti E, Rizzo MR, Rossi A, Volpato S, Landi F. The incidence of sarcopenia among hospitalized older patients: results from the Glisten study. J Cachexia Sarcopenia Muscle. 2017 Dec;8(6):907-914. doi: 10.1002/jcsm.12224. Epub 2017 Sep 14.
- Results publication: PubMed 28288651Lo YC, Wahlqvist ML, Huang YC, Chuang SY, Wang CF, Lee MS. Medical costs of a low skeletal muscle mass are modulated by dietary diversity and physical activity in community-dwelling older Taiwanese: a longitudinal study. Int J Behav Nutr Phys Act. 2017 Mar 14;14(1):31. doi: 10.1186/s12966-017-0487-x.
- Results publication: PubMed 32033882Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Cerebral Stroke, run by Cishan Hospital, Ministry of Health and Welfare at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appendicular Skeletal Muscle Mass Index (time frame: at enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07492849, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.