跳至主要内容
临床试验/NCT04387747
NCT04387747已完成不适用

Evaluation Of Sarcopenia In Stroke Patients

Istanbul Physical Medicine Rehabilitation Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2019年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
81
试验地点
1
主要终点
Functional Ambulation Classification (FAC)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Functional Ambulation Classification (FAC)

时间窗: 1 interview day

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.

24-hour dietary recall (24HR) method

时间窗: 1 interview day

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.

Glim Criteria

时间窗: 1 interview day

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.

sarcopenia

时间窗: 1 interview day

The walking speed ≥0.8 m / s, SARC-F score ≥4, short physical performance battery score ≤ 8, thigh circumference \<33cm.

EQ-5D

时间窗: 1 interview day

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).

次要结局

  • Brunnstrom's staging(1 interview day)
  • Barthel index(1 interview day)
  • Modified Ashworth Scale(1 interview day)

研究者

发起方
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Tuğba Aydın

Principal Investigator

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

研究点 (1)

Loading locations...

相似试验

Evaluation of Sarcopenia in Patients With Stroke | 临床试验