SarcopeniaNCT02793362
Measurement of Sarcopenia at Post-stroke Rehabilitation Outcome
An observational study of Sarcopenia, run by Bucheon St. Mary's Hospital at 1 site in South Korea.
Trial summary
The purposes of this study are 1. To explore effect of sarcopenia on recovery of post stroke hemiplegia 2. To explore the effect of stroke on sarcopenia and relationship between the degree of sarcopenia and respiration and swallowing function 3. To quantify and qualify post stroke loss of muscle mass 4. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2016to 30 Dec 2018
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Recruited subjects will be allocated into 3 different groups. 1. Normal subjects without stroke (30 healthy volunteers) 2. Post stroke patients with sarcopenia (40 first ever stroke patients who admitted to Bucheon St. Mary's Hospital) 3. Post stroke patients without sarcopenia (40 first ever stroke patients who admitted to Bucheon St. Mary's Hospital)
Who may be able to join
- First ever subacute stroke patients whose lesions were confirmed in brain imaging (MRI/CT)
- Patients who did not have difficulty in premorbid ambulation or activities of daily living.
- Patients who can follow 1 step obey
- Patients who can perform hand function test
- Patients whose laboratory tests, neurologic, cognitive, and dysphagia evaluations are completed within 1 month from the onset date.
- Patients who admitted/transferred into our department for at least 4 weeks, following conventional rehabilitation protocols.
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- Patients with at least 2 of MRS(Modified Ranking Score) and FAC(Functional ambulation category) scores.
- Subjects who can walk independent without any difficult
- Subjects without history of CNS or PNS lesion
- MRS(Modified ranking scale) <=2
- FAC(functional ambulation category) >=2
Who cannot join
- Patients who do not meet the above listed criteria
- Patients with double hemiplegia
- Patients with other systemic diseases that can affect loss of muscle mass or causr malnutrition. (Example : chronic inflammatory disease, autoimmune disease, chronic intestinalis, active tuberculosis, immunocompromised state, AIDS, malignancy, pregnancy, amputation, or operation.
- Patients with joint contracture who are difficult to perform sonographic evaluation.
- Traumatic brain injury patients.
- Patients with other systemic diseases that can affect loss of muscle mass or causr malnutrition. (Example : chronic inflammatory disease, autoimmune disease, chronic intestinalis, active tuberculosis, immunocompromised state, AIDS, malignancy, pregnancy, amputation, or operation.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggi-do, 14647
About this study
The purposes of this study are
- To explore effect of sarcopenia on recovery of post stroke hemiplegia
- To explore the effect of stroke on sarcopenia and relationship between the degree of sarcopenia and respiration and swallowing function
- To quantify and qualify post stroke loss of muscle mass
- To validity the use of echointensity and elastography in evaluation of sarcopenia.
By reaching the above list purposes, sarcopenia can be viewed as one of serious post stroke complications that is closely related to worth functional outcome, thereby emphasizing the importance of evaluation of sarcopenia as well as its prevention.
Read the detailed description
Sarcopenia occurs frequently among old population. The changes can rather occur earlier after trauma or generalized illness. However, the nature of these sarcopenia is different from that of geriatric population. Post stroke sarcopenia is underestimated however reduction in the motor uni number begins within 4 hours post stroke and after 3 weeks, sarcopenia can be seen in both hemiplegia and normal side. This muscular weakness can hinder functional recovery process.
- Conditions
- Sarcopenia
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal subjects without stroke | 1. subjects who can walk independent without any difficult 2. subjects without history of CNS or PNS lesion 3. Modified ranking scale (MRS) <=2 4. Functional ambulation category (FAC) >=2 | |
| Post stroke patients with sarcopenia(by sarcopenia index) | Existence of sarcopenia will be determined by DEXA scan where sarcopenia index of male less than 7.40 kg/m2, that of female less than 5. 14 kg/m2 are considered as sarcopenia. | |
| Post stroke patients without sarcopenia(by sarcopenia index) | patients who do not satisfy the value of DEXA scan where sarcopenia index of male less than 7.40 kg/m2, that of female less than 5. 14 kg/m2 are considered as sarcopenia. | |
| Post stroke patients with sarcopenia(by lean body mass) | Existence of sarcopenia will be determined by DEXA scan where appendicular lean mass less than <19.75 kg in men, and <15.02 kg in women are considered sarcopenia. | |
| Post stroke patients without sarcopenia(by lean body mass) | patienst who do not satisfy the value of DEXA scan where appendicular lean mass less than <19.75 kg in men, and <15.02 kg in women are considered sarcopenia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in K-MBI score from initial evaluation to the final evaluation
Measured: 8 weeks, 12 weeks, 16 weeks from the first onset of the stroke
Secondary outcomes (5)
Change in Berg balance scale from initial evaluation to the final evaluation
Measured: 8 weeks, 12 weeks, 16 weeks from the first onset of the stroke
Change in Fatigue scale from initial evaluation to the final evaluation
Measured: 8 weeks, 12 weeks, 16 weeks from the first onset of the stroke
Change in Motricity index from initial evaluation to the final evaluation
Measured: 8 weeks, 12 weeks, 16 weeks from the first onset of the stroke
Change in Functional Oral Intake Scale (FOIS) from initial evaluation to the final evaluation
Measured: 8 weeks, 12 weeks, 16 weeks from the first onset of the stroke
Change in MMSE from initial evaluation to the final evaluation
Measured: 8 weeks, 12 weeks, 16 weeks from the first onset of the stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startMay 2016
- Primary completion30 May 2017
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bucheon St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geun-Young Park, Bucheon St. Mary's Hospital
- Investigators
- Geun-Young Park, Study director, Bucheon St. Mary's HospitalYongmin Choi, Principal investigator, Bucheon St. Mary's HospitalSun Im, Study director, Bucheon St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793362
- Sponsor's protocol ID
- HC16OIS0028
- Status last verified
- Jan 2019
- First submitted
- 30 May 2016
- Last updated
- 3 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Sarcopenia at Post-stroke Rehabilitation Outcome
- ClinicalTrials.gov ID
- NCT02793362
- Acronym / sponsor ID
- HC16OIS0028
- Conditions
- Sarcopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Bucheon St. Mary's HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 8 Jun 2016 (estimated)
- 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.
The purposes of this study are
- To explore effect of sarcopenia on recovery of post stroke hemiplegia
- To explore the effect of stroke on sarcopenia and relationship between the degree of sarcopenia and respiration and swallowing function
- To quantify and qualify post stroke loss of muscle mass
- To validity the use of echointensity and elastography in evaluation of sarcopenia.
By reaching the above list purposes, sarcopenia can be viewed as one of serious post stroke complications that is closely related to worth functional outcome, thereby emphasizing the importance of evaluation of sarcopenia as well as its prevention.
Detailed description
Sarcopenia occurs frequently among old population. The changes can rather occur earlier after trauma or generalized illness. However, the nature of these sarcopenia is different from that of geriatric population. Post stroke sarcopenia is underestimated however reduction in the motor uni number begins within 4 hours post stroke and after 3 weeks, sarcopenia can be seen in both hemiplegia and normal side. This muscular weakness can hinder functional recovery process.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Normal subjects without stroke | – | –1. subjects who can walk independent without any difficult 2. subjects without history of CNS or PNS lesion 3. Modified ranking scale (MRS) <=2 4. Functional ambulation category (FAC) >=2 |
| Post stroke patients with sarcopenia(by sarcopenia index) | – | –Existence of sarcopenia will be determined by DEXA scan where sarcopenia index of male less than 7.40 kg/m2, that of female less than 5. 14 kg/m2 are considered as sarcopenia. |
| Post stroke patients without sarcopenia(by sarcopenia index) | – | –patients who do not satisfy the value of DEXA scan where sarcopenia index of male less than 7.40 kg/m2, that of female less than 5. 14 kg/m2 are considered as sarcopenia. |
| Post stroke patients with sarcopenia(by lean body mass) | – | –Existence of sarcopenia will be determined by DEXA scan where appendicular lean mass less than <19.75 kg in men, and <15.02 kg in women are considered sarcopenia. |
| Post stroke patients without sarcopenia(by lean body mass) | – | –patienst who do not satisfy the value of DEXA scan where appendicular lean mass less than <19.75 kg in men, and <15.02 kg in women are considered sarcopenia. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Recruited subjects will be allocated into 3 different groups. 1. Normal subjects without stroke (30 healthy volunteers) 2. Post stroke patients with sarcopenia (40 first ever stroke patients who admitted to Bucheon St. Mary's Hospital) 3. Post stroke patients without sarcopenia (40 first ever stroke patients who admitted to Bucheon St. Mary's Hospital)
Key inclusion criteria (11 listed)
- First ever subacute stroke patients whose lesions were confirmed in brain imaging (MRI/CT)
- Patients who did not have difficulty in premorbid ambulation or activities of daily living.
- Patients who can follow 1 step obey
- Patients who can perform hand function test
- Patients whose laboratory tests, neurologic, cognitive, and dysphagia evaluations are completed within 1 month from the onset date.
Key exclusion criteria (6 listed)
- Patients who do not meet the above listed criteria
- Patients with double hemiplegia
- Patients with other systemic diseases that can affect loss of muscle mass or causr malnutrition. (Example : chronic inflammatory disease, autoimmune disease, chronic intestinalis, active tuberculosis, immunocompromised state, AIDS, malignancy, pregnancy, amputation, or operation.
- Patients with joint contracture who are difficult to perform sonographic evaluation.
- Traumatic brain injury patients.
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
Change in K-MBI score from initial evaluation to the final evaluation
Time frame: 8 weeks, 12 weeks, 16 weeks from the first onset of the stroke
5 secondary outcomes
Change in Berg balance scale from initial evaluation to the final evaluation
Time frame: 8 weeks, 12 weeks, 16 weeks from the first onset of the stroke
Change in Fatigue scale from initial evaluation to the final evaluation
Time frame: 8 weeks, 12 weeks, 16 weeks from the first onset of the stroke
Change in Motricity index from initial evaluation to the final evaluation
Time frame: 8 weeks, 12 weeks, 16 weeks from the first onset of the stroke
Change in Functional Oral Intake Scale (FOIS) from initial evaluation to the final evaluation
Time frame: 8 weeks, 12 weeks, 16 weeks from the first onset of the stroke
Change in MMSE from initial evaluation to the final evaluation
Time frame: 8 weeks, 12 weeks, 16 weeks from the first onset of the stroke
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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.
Geun-Young Park study director
Bucheon St. Mary's Hospital
Yongmin Choi principal investigator
Bucheon St. Mary's Hospital
Sun Im study director
Bucheon St. Mary's 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 Sarcopenia, run by Bucheon St. Mary's Hospital at 1 site in South Korea.
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 11 inclusion and 6 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 3 Jan 2019. 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 South Korea. 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?
Change in K-MBI score from initial evaluation to the final evaluation (time frame: 8 weeks, 12 weeks, 16 weeks from the first onset of the stroke). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jan 2019; AzTrials last refreshed its copy on 8 Nov 2026.