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SarcopeniaNCT04387747

Evaluation of Sarcopenia in Patients With Stroke

An observational study of Sarcopenia and Stroke, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Sarcopenia, Stroke
What is being tested?
SARCOPENIA IN STROKE PATIENTS
How many people
81 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Sep 2019to 1 Jun 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Inpatient stroke cases

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

    Istanbul, 34192

Other trials in Turkey (Türkiye)

About this study

Official title: 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

Read the 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.

Conditions
Sarcopenia, Stroke
Being tested
SARCOPENIA IN STROKE PATIENTS
Keywords
sarcopenia, stroke
Medical subject headings
Sarcopenia, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SARCOPENIA IN STROKE PATIENTSOther

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 interview day

  2. 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.

    Measured: 1 interview day

  3. 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.

    Measured: 1 interview day

  4. sarcopenia

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

    Measured: 1 interview day

  5. 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).

    Measured: 1 interview day

Secondary outcomes (3)

  1. 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.

    Measured: 1 interview day

  2. 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.

    Measured: 1 interview day

  3. 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.

    Measured: 1 interview day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2020
  2. Study start15 Sep 2019
  3. Primary completion1 Jun 2020
  4. Study completion1 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04387747
Sponsor's protocol ID
ıstPMRTRH-SRCPN
Status last verified
May 2020
First submitted
11 May 2020
Last updated
30 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 25676847

  • 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.

    PubMed 27530769

  • 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.

    PubMed 34356039

Questions about this trial

What is this clinical trial studying?

An observational study of Sarcopenia and Stroke, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Ambulation Classification (FAC) (time frame: 1 interview day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04387747, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2020.

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