Evaluation of Sarcopenia in Patients With Stroke

Evaluation Of Sarcopenia In Stroke Patients

The aim of this study is to investigate the prevalence of sarcopenia in stroke patients; to determine the relationship between sarcopenia and duration of stroke, age, gender, etiology of stroke, ambulation status, spasticity, nutrition and malnutrition

Study Overview

• Status: Completed
• Conditions: Stroke; Sarcopenia
• Intervention / Treatment: Other: SARCOPENIA IN STROKE PATIENTS

Detailed Description

Sarcopenia was defined as a loss of skeletal muscle mass and decreased muscle strength. The purpose of this study was to investigate the prevalence of sarcopenia following stroke, to investigate the relationship between sarcopenia and duration of stroke, age, sex, etiology of stroke, ambulation status, spasticity, nutrition and malnutrition. Demographic characteristics, duration of stroke, sarcopenia presence (walking speed ≥ 0.8 m / s, SARC-F score ≥4, short physical performance battery score ≤ 8, thigh circumference <33cm (The data for Turkey) <31cm (European data)) were recorded. Hand grip strength (jamar) measured from the intact hand and TANITA BIA analysis were planned for all patients.

Ambulation level with Functional Ambulation Classification (FAC), nutritional status with 24-hour dietary recall (24HR) method, diagnosis of malnutrition with Glim Criteria, spasticity with Modified Ashworth Scale, motor development for stroke patient Brunnstrom staging, screening for frailty with Frail questionnaire activity of daily living were evaluated with Barthel Index.

• Study Type: Observational
• Enrollment (Actual): 81

Contacts and Locations

Study Locations

• Turkey
  • İstanbul, Turkey, 34192
    • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Inpatient stroke cases

Description

Inclusion Criteria:

• Patients with chronic stroke (Stroke duration > 3 months)
• Patients with a FAC score > 3

Exclusion Criteria:

• Patients unable to cooperate
• Other diseases that cause gait disorders such as neuromuscular disease, cardiopulmonary problems.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Ambulation Classification (FAC)	The Functional Ambulation Categories (FAC) is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. FAC stage 0 indicates the non-functional ambulation, and stage 5 indicates the independent walking at each speed and on ground.	1 interview day
24-hour dietary recall (24HR) method	24-hour dietary recall method consists of precisely recalling, describing and quantifying the intake of foods and beverages consumed during the day before the interview, from the first intake in the morning until the last foods or beverages consumed at night.	1 interview day
Glim Criteria	The five criteria for malnutrition include non-volitional weight loss, low body mass index, and reduced muscle mass as phenotypic criteria, and reduced food intake/assimilation and inflammation/disease burden as etiologic criteria. It is proposed that the diagnosis of malnutrition be based upon the presence of at least one phenotypic criterion and one etiologic criterion.	1 interview day
sarcopenia	The walking speed ≥0.8 m / s, SARC-F score ≥4, short physical performance battery score ≤ 8, thigh circumference <33cm.	1 interview day
EQ-5D	EQ-5D-3L is used to evaluate the quality of life. This scale scores five health conditions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) through evaluation in 3 levels (no problems, some problems, extreme problems).	1 interview day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barthel index	The Barthel Index measures the activity limitations in patients with neuromuscular disease. The Barthel Index are assessed, including toileting, bathing, eating, dressing, continence, transfers, and ambulation. A client scoring 0 points would be dependent in all assessed activities of daily living, whereas a score of 100 would reflect independence in these activities.	1 interview day
Brunnstrom's staging	Brunnstrom's staging is used to evaluate the sequence of motor development and reorganization of the brain after stroke in six stages. Stage 1: Flaccidity; Stage 2: Spasticity Appears; Stage 3: Increased Spasticity; Stage 4: Decreased Spasticity; Stage 5: Spasticity Continues to Decrease; Stage 6: Spasticity Disappears and Coordination Reappears.	1 interview day
Modified Ashworth Scale	The Modified Ashworth scale (MAS) measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. Scoring: 0: No increase in muscle tone; 1: Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension; 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM; 2: More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved; 3: Considerable increase in muscle tone, passive movement difficult; 4: Affected part(s) rigid in flexion or extension.	1 interview day

Collaborators and Investigators

• Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Investigators: Principal Investigator: TUGBA AYDIN, MD, Istanbul Physical Medicine Rehabilitation Training & Research Hospital

Publications and helpful links

General Publications

• 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.
• Ryan AS, Ivey FM, Serra MC, Hartstein J, Hafer-Macko CE. Sarcopenia and Physical Function in Middle-Aged and Older Stroke Survivors. Arch Phys Med Rehabil. 2017 Mar;98(3):495-499. doi: 10.1016/j.apmr.2016.07.015. Epub 2016 Aug 13.
• Aydin T, Kesiktas FN, Oren MM, Erdogan T, Ahisha YC, Kizilkurt T, Corum M, Karacan I, Ozturk S, Bahat G. Sarcopenia in patients following stroke: an overlooked problem. Int J Rehabil Res. 2021 Sep 1;44(3):269-275. doi: 10.1097/MRR.0000000000000487.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2019
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: May 11, 2020
• First Submitted That Met QC Criteria: May 13, 2020
• First Posted (Actual): May 14, 2020

Study Record Updates

• Last Update Posted (Actual): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 26, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: stroke; sarcopenia
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Stroke; Sarcopenia
• Other Study ID Numbers: ıstPMRTRH-SRCPN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No