Measurement of Sarcopenia at Post-stroke Rehabilitation Outcome

NCT ID: NCT02793362

Last Updated: 2019-01-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2018-12-30

Brief 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. 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.

Conditions

Sarcopenia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.
• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bucheon St. Mary's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Geun-Young Park

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Geun-Young Park

Role: STUDY_DIRECTOR

Bucheon St. Mary's Hospital

Yongmin Choi

Role: PRINCIPAL_INVESTIGATOR

Bucheon St. Mary's Hospital

Sun Im

Role: STUDY_DIRECTOR

Bucheon St. Mary's Hospital

Locations

Bucheon St. Mary's Hospital

Bucheon-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

HC16OIS0028

Identifier Type: -

Identifier Source: org_study_id