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Completed

NCT Number: NCT04387747

Evaluation of Sarcopenia in Patients With Stroke

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

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, 34192, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SARCOPENIA IN STROKE PATIENTS

Other

Demographic characteristics, duration of stroke, sarcopenia presence,thigh circumference , Hand grip strength , TANITA BIA analysis

Primary outcomes

  1. Functional Ambulation Classification (FAC)

    Time frame: 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.

  2. 24-hour dietary recall (24HR) method

    Time frame: 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.

  3. Glim Criteria

    Time frame: 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.

  4. sarcopenia

    Time frame: 1 interview day

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

  5. EQ-5D

    Time frame: 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).

Secondary outcomes

  1. Barthel index

    Time frame: 1 interview day

    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.

  2. Brunnstrom's staging

    Time frame: 1 interview day

    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.

  3. Modified Ashworth Scale

    Time frame: 1 interview day

    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.

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Official study title

Evaluation Of Sarcopenia In Stroke Patients

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 14, 2020
Registry last updated
Jun 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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