NCT07492849

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 25, 2026

Completed
Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

March 20, 2026

Last Update Submit

March 28, 2026

Conditions

Keywords

strokesarcopeniaAppendicular Skeletal Muscle MassMini Nutritional AssessmentPost-Acute Care

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (8)

  • maximal voluntary isometric contraction of quadriceps

    at enrollment

  • Sonographic thickness of quadriceps muscle

    at enrollment

  • Sonographic thickness of gastrocnemius muscle

    at enrollment

  • Calf Circumference

    at enrollment

  • Sarcopenia risk assessed by the Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls (SARC-F) questionnaire

    at enrollment

  • +3 more secondary outcomes

Study Arms (2)

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.

Diagnostic Test: Objective assessmentsDiagnostic 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.

Diagnostic Test: Objective assessmentsDiagnostic Test: Subjective assessment

Interventions

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.

Chronic stroke patientsPost-acute stroke patients
Subjective assessmentDIAGNOSTIC_TEST

involves the EQ-5D questionnaire to evaluate health-related quality of life

Chronic stroke patientsPost-acute stroke patients

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.
  • 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.
  • 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. -

You may not qualify if:

  • 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). -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CiShan hospital, MOHW

Kaohsiung City, 842, Taiwan

Location

Related Publications (14)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

SarcopeniaStroke

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

March 20, 2026

First Posted

March 25, 2026

Study Start

May 5, 2025

Primary Completion

October 4, 2025

Study Completion

March 1, 2026

Last Updated

April 2, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations