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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Objective assessments | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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. | at enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at enrollment |
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Inclusion Criteria:
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. -
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CiShan hospital, MOHW | Kaohsiung City | 842 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31207438 | Result | 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. | |
| 35418607 | Result | Shimizu 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 10, 2025 | Mar 25, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 10, 2025 | Mar 25, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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|
| Subjective assessment | Diagnostic Test | involves the EQ-5D questionnaire to evaluate health-related quality of life |
|
| 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. | 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:
| 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. | 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. | 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. | 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. | 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. | at enrollment |
| 35461188 | Result | Kanai 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. |
| 35370897 | Result | Lee 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. |
| 35587756 | Result | Abe 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. |
| 24231058 | Result | Scherbakov 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. |
| 25676847 | Result | Scherbakov 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. |
| 30580719 | Result | Sennfalt 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. |
| 34870689 | Result | Toyoda 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. |
| 28913934 | Result | Martone 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. |
| 28288651 | Result | Lo 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. |
| 32033882 | Result | Chen 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. |
| 20392703 | Result | Cruz-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. |
| 31171417 | Result | Cruz-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. |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |