StrokeNCT05456646
The Change in Temporal Muscle Thickness in Stroke Patients
An observational study of Stroke and Sarcopenia, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the relationship between sarcopenia and functional outcomes with temporal muscle mass change. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Sarcopenia
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2022to Apr 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A tertiary health care facility
Who may be able to join
- Diagnosis of stroke
- Presence of cranial MRI/CT in hospital records
Who cannot join
- Medically unstable condition (presence or high risk of impaired consciousness, respiration, or circulation).
- Severe cognitive impairment
- Patients who require intensive care unit.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Bozyaka Research and Training Hostpital
Izmir
About this study
Official title: The Change in Temporal Muscle Thickness and Its Relationship With Sarcopenia and Functional Outcomes in Stroke Patients.
This study aims to evaluate the relationship between sarcopenia and functional outcomes with temporal muscle mass change.
Read the 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.
- Conditions
- Stroke, Sarcopenia
- Medical subject headings
- Stroke, Sarcopenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Ambulation Scale
This scale consists of six levels of function, ranging from 0 ( non-ambulatory ) to 5 (independently ambulatory).
Measured: Baseline
Functional Ambulation Scale
This scale consists of six levels of function, ranging from 0 ( non-ambulatory ) to 5 (independently ambulatory).
Measured: 6. month
The Functional Independence Measure (FIM)
FIM is a scale that assesses 18 activities, including self-care, sphincter control, transfer, movement, communication, and social awareness. Total scores range from 18 to 126 (dependent in all domains - independent in all domains).
Measured: Baseline
The Functional Independence Measure (FIM)
FIM is a scale that assesses 18 activities, including self-care, sphincter control, transfer, movement, communication, and social awareness. Total scores range from 18 to 126 (dependent in all domains - independent in all domains).
Measured: 6.month
Modified Rankin Scale (mRS)
It categorizes poststroke disability into six levels ranging from 0 to 5, with absence of symptoms rated as 0 and severe disability or bedriddenness rated as 5. An mRS score of 2 or less was defined as a good outcome, and an mRS score above 2 was defined as a poor outcome.
Measured: Baseline
Modified Rankin Scale (mRS)
It categorizes poststroke disability into six levels ranging from 0 to 5, with absence of symptoms rated as 0 and severe disability or bedriddenness rated as 5. An mRS score of 2 or less was defined as a good outcome, and an mRS score above 2 was defined as a poor outcome.
Measured: 6. month
Handgrip strength
With the JAMAR Hand Dynamometer, 3 measurements will be taken for both hands 60 seconds apart in the standard position and the highest reading will be recorded.
Measured: Baseline
Handgrip strength
With the JAMAR Hand Dynamometer, 3 measurements will be taken for both hands 60 seconds apart in the standard position and the highest reading will be recorded.
Measured: 6. month
Dual energy X-ray absorptiometry (DEXA)
DEXA can be used to determine lean body mass and total body fat. The appendicular skeletal mass index will be used in the evaluation of sarcopenia and in other analyzes.
Measured: Baseline
Dual energy X-ray absorptiometry (DEXA)
DEXA can be used to determine lean body mass and total body fat. The appendicular skeletal mass index will be used in the evaluation of sarcopenia and in other analyzes.
Measured: 6.month
Bioelectrical impedance analysis (BIA)
Body water mass, total body fat, and muscle mass can be determined with BIA.The appendicular skeletal mass index will be used in the evaluation of sarcopenia and in other analyzes.
Measured: Baseline
Bioelectrical impedance analysis (BIA)
Body water mass, total body fat, and muscle mass can be determined with BIA.The appendicular skeletal mass index will be used in the evaluation of sarcopenia and in other analyzes.
Measured: 6.month
Functional Oral Intake Scale
The scale is rated with values between 1 and 7. Level 1-3 refers to tube-dependent feeding, level 4-6 to full oral feeding with restrictions, and level 7 to oral feeding without restrictions.
Measured: Baseline
Functional Oral Intake Scale
The scale is rated with values between 1 and 7. Level 1-3 refers to tube-dependent feeding, level 4-6 to full oral feeding with restrictions, and level 7 to oral feeding without restrictions.
Measured: 6. month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start15 Jul 2022
- Primary completionMar 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bozyaka Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bugra Ince, MD, Principal investigator, Izmir Bozyaka Education and Resarch Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456646
- Sponsor's protocol ID
- BITMS0722
- Status last verified
- Jan 2023
- First submitted
- 11 Jul 2022
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: upon request
Publications
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 27530769Nozoe 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.
PubMed 31207438Nakanishi 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.
PubMed 33756264
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Change in Temporal Muscle Thickness and Its Relationship With Sarcopenia and Functional Outcomes in Stroke Patients.
- ClinicalTrials.gov ID
- NCT05456646
- Acronym / sponsor ID
- BITMS0722
- Conditions
- Stroke, Sarcopenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Bozyaka Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A tertiary health care facility
Key inclusion criteria (2 listed)
- Diagnosis of stroke
- Presence of cranial MRI/CT in hospital records
Key exclusion criteria (3 listed)
- Medically unstable condition (presence or high risk of impaired consciousness, respiration, or circulation).
- Severe cognitive impairment
- Patients who require intensive care unit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional Ambulation Scale
Time frame: Baseline
This scale consists of six levels of function, ranging from 0 ( non-ambulatory ) to 5 (independently ambulatory).
Functional Ambulation Scale
Time frame: 6. month
This scale consists of six levels of function, ranging from 0 ( non-ambulatory ) to 5 (independently ambulatory).
The Functional Independence Measure (FIM)
Time frame: Baseline
FIM is a scale that assesses 18 activities, including self-care, sphincter control, transfer, movement, communication, and social awareness. Total scores range from 18 to 126 (dependent in all domains - independent in all domains).
The Functional Independence Measure (FIM)
Time frame: 6.month
FIM is a scale that assesses 18 activities, including self-care, sphincter control, transfer, movement, communication, and social awareness. Total scores range from 18 to 126 (dependent in all domains - independent in all domains).
Modified Rankin Scale (mRS)
Time frame: Baseline
It categorizes poststroke disability into six levels ranging from 0 to 5, with absence of symptoms rated as 0 and severe disability or bedriddenness rated as 5. An mRS score of 2 or less was defined as a good outcome, and an mRS score above 2 was defined as a poor outcome.
Modified Rankin Scale (mRS)
Time frame: 6. month
It categorizes poststroke disability into six levels ranging from 0 to 5, with absence of symptoms rated as 0 and severe disability or bedriddenness rated as 5. An mRS score of 2 or less was defined as a good outcome, and an mRS score above 2 was defined as a poor outcome.
Handgrip strength
Time frame: Baseline
With the JAMAR Hand Dynamometer, 3 measurements will be taken for both hands 60 seconds apart in the standard position and the highest reading will be recorded.
Handgrip strength
Time frame: 6. month
With the JAMAR Hand Dynamometer, 3 measurements will be taken for both hands 60 seconds apart in the standard position and the highest reading will be recorded.
Dual energy X-ray absorptiometry (DEXA)
Time frame: Baseline
DEXA can be used to determine lean body mass and total body fat. The appendicular skeletal mass index will be used in the evaluation of sarcopenia and in other analyzes.
Dual energy X-ray absorptiometry (DEXA)
Time frame: 6.month
DEXA can be used to determine lean body mass and total body fat. The appendicular skeletal mass index will be used in the evaluation of sarcopenia and in other analyzes.
Bioelectrical impedance analysis (BIA)
Time frame: Baseline
Body water mass, total body fat, and muscle mass can be determined with BIA.The appendicular skeletal mass index will be used in the evaluation of sarcopenia and in other analyzes.
Bioelectrical impedance analysis (BIA)
Time frame: 6.month
Body water mass, total body fat, and muscle mass can be determined with BIA.The appendicular skeletal mass index will be used in the evaluation of sarcopenia and in other analyzes.
Functional Oral Intake Scale
Time frame: Baseline
The scale is rated with values between 1 and 7. Level 1-3 refers to tube-dependent feeding, level 4-6 to full oral feeding with restrictions, and level 7 to oral feeding without restrictions.
Functional Oral Intake Scale
Time frame: 6. month
The scale is rated with values between 1 and 7. Level 1-3 refers to tube-dependent feeding, level 4-6 to full oral feeding with restrictions, and level 7 to oral feeding without restrictions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Background: PubMed 27530769Ryan 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.
- Background: PubMed 31207438Nozoe 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.
- Background: PubMed 33756264Nakanishi 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.
- Individual participant dataSharing planned: Undecided. upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bugra Ince, MD principal investigator
Izmir Bozyaka Education and Resarch Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Sarcopenia, run by Bozyaka 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 3 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: status not confirmed, as of the sponsor's last update on 5 Sep 2023. 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?
Results are not available in the source record.
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 Scale (time frame: Baseline). The study lists 14 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 NCT05456646, 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 5 Sep 2023.