NCT04387747

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

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

September 15, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 14, 2020

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

June 30, 2020

Status Verified

May 1, 2020

Enrollment Period

9 months

First QC Date

May 11, 2020

Last Update Submit

June 26, 2020

Conditions

Keywords

sarcopeniastroke

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (3)

  • Barthel index

    1 interview day

  • Brunnstrom's staging

    1 interview day

  • Modified Ashworth Scale

    1 interview day

Interventions

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

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inpatient stroke cases

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, 34192, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 25676847BACKGROUND
  • 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.

    PMID: 27530769BACKGROUND
  • 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.

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 Officials

  • TUGBA AYDIN, MD

    Istanbul Physical Medicine Rehabilitation Training & Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 11, 2020

First Posted

May 14, 2020

Study Start

September 15, 2019

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

June 30, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations