Clinical trial NCT04387747: Evaluation of Sarcopenia in Patients With Stroke
Official title: Evaluation Of Sarcopenia In Stroke Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcopenia
Stroke
Keywords: sarcopenia
stroke
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-05-14
Enrollment: 81
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatient stroke cases

Brief summary: 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Functional Ambulation Classification (FAC)
timeFrame: 1 interview day
measure: 24-hour dietary recall (24HR) method
timeFrame: 1 interview day
measure: Glim Criteria
timeFrame: 1 interview day
measure: sarcopenia
timeFrame: 1 interview day
measure: EQ-5D
timeFrame: 1 interview day
Secondary outcomes:
measure: Barthel index
timeFrame: 1 interview day
measure: Brunnstrom's staging
timeFrame: 1 interview day
measure: Modified Ashworth Scale
timeFrame: 1 interview day
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Study officials:
affiliation: Istanbul Physical Medicine Rehabilitation Training & Research Hospital
name: TUGBA AYDIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.