Clinical trial NCT05456646: The Change in Temporal Muscle Thickness in Stroke Patients
Official title: The Change in Temporal Muscle Thickness and Its Relationship With Sarcopenia and Functional Outcomes in Stroke Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Sarcopenia
Lead sponsor: Bozyaka Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A tertiary health care facility

Brief summary: This study aims to evaluate the relationship between sarcopenia and functional outcomes with temporal muscle mass change.

Detailed description: It is well known that stroke increases the risk of developing sarcopenia . In addition, prestroke sarcopenia is associated with worse functional outcomes in patients with stroke. Temporal muscle thickness (TMT) has recently been proposed as a new marker of whole-body muscle mass and function. Measurement of temporal muscle mass by computed tomography (CT) and magnetic resonance imaging (MRI) has been studied in the literature in recent years. All stroke patients undergo cranial CT or MRI examinations at the time of admission. By evaluating the temporal muscle mass of these patients with these examinations, information about pre-stroke muscle mass and sarcopenia can be obtained. Ultrasonography (USG), on the other hand, may be a more accessible, less expensive, and safer option for assessing muscle mass in the follow-up of stroke patients. This study aims to evaluate the relationship between sarcopenia and functional outcomes with temporal muscle mass change by MRI/CT at admission and by USG in the chronic period.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of stroke
* Presence of cranial MRI/CT in hospital records

Exclusion Criteria:

* Medically unstable condition (presence or high risk of impaired consciousness, respiration, or circulation).
* Severe cognitive impairment
* Patients who require intensive care unit.

Primary outcomes:
measure: Functional Ambulation Scale
timeFrame: Baseline
measure: Functional Ambulation Scale
timeFrame: 6. month
measure: The Functional Independence Measure (FIM)
timeFrame: Baseline
measure: The Functional Independence Measure (FIM)
timeFrame: 6.month
measure: Modified Rankin Scale (mRS)
timeFrame: Baseline
measure: Modified Rankin Scale (mRS)
timeFrame: 6. month
measure: Handgrip strength
timeFrame: Baseline
measure: Handgrip strength
timeFrame: 6. month
measure: Dual energy X-ray absorptiometry (DEXA)
timeFrame: Baseline
measure: Dual energy X-ray absorptiometry (DEXA)
timeFrame: 6.month
measure: Bioelectrical impedance analysis (BIA)
timeFrame: Baseline
measure: Bioelectrical impedance analysis (BIA)
timeFrame: 6.month
measure: Functional Oral Intake Scale
timeFrame: Baseline
measure: Functional Oral Intake Scale
timeFrame: 6. month
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Izmir Bozyaka Research and Training Hostpital
Study officials:
affiliation: Izmir Bozyaka Education and Resarch Hospital
name: Bugra Ince, MD
role: PRINCIPAL_INVESTIGATOR
References:
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: Nozoe M, Kanai M, Kubo H, Yamamoto M, Shimada S, Mase K. Prestroke sarcopenia and functional outcomes in elderly patients who have had an acute stroke: A prospective cohort study. Nutrition. 2019 Oct;66:44-47. doi: 10.1016/j.nut.2019.04.011. Epub 2019 Apr 25.
citation: Nakanishi N, Okura K, Okamura M, Nawata K, Shinohara A, Tanaka K, Katayama S. Measuring and Monitoring Skeletal Muscle Mass after Stroke: A Review of Current Methods and Clinical Applications. J Stroke Cerebrovasc Dis. 2021 Jun;30(6):105736. doi: 10.1016/j.jstrokecerebrovasdis.2021.105736. Epub 2021 Mar 20.