Status Approved
First Submitted Date
2020/09/21
Registered Date
2020/10/21
Last Updated Date
2021/02/26
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005514 |
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Unique Protocol ID | 2020-06-020-002 |
Public/Brief Title | Effect of Sarcopenia on Postoperative rehabilitation |
Scientific Title | Effect of Sarcopenia on Postoperative rehabilitation |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | 2020-06-020-002 |
Approval Date | 2020-08-24 |
Institutional Review Board Name | Chosun university hospital Institutional Review Board |
Institutional Review Board Address | 365, Pilmun-daero, Dong-gu, Gwangju |
Institutional Review Board Telephone | 062-220-3268 |
Data Monitoring Committee |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Suenghwan Jo |
Title | associate professor |
Telephone | +82-62-220-3147 |
Affiliation | Chosun University |
Address | 365, Pilmun-daero, Dong-gu, Gwangju, Republic of Korea |
Contact Person for Public Queries | |
Name | Suenghwan Jo |
Title | associate professor |
Telephone | +82-62-220-3147 |
Affiliation | Chosun University |
Address | 365, Pilmun-daero, Dong-gu, Gwangju, Republic of Korea |
Contact Person for Updating Information | |
Name | Suenghwan Jo |
Title | associate professor |
Telephone | +82-62-220-3147 |
Affiliation | Chosun University |
Address | 365, Pilmun-daero, Dong-gu, Gwangju, Republic of Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-01-14 Actual | |
Target Number of Participant | 100 | |
Primary Completion Date | ||
Study Completion Date | ||
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Chosun University Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-01-14 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | National Research Foundation |
Organization Type | Others |
Project ID | 2018R1c1B5085 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Chosun University Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | For elderly patients, rehabilitation after surgery is not easy. In other words, even if the surgical treatment is successfully performed, muscle strength is not restored, and walking ability and daily life after surgery are often significantly reduced. Therefore, this study aims to find out how preoperative muscle strength affects the patient's gait and daily life after surgery in elderly patients. |
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8. Study Design
Study Type | Observational Study |
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Observational Study Model | Cohort |
Time Perspective | Prospective |
Target Number of Participant | 100 |
Cohort/Group Number | 1 |
Cohort/ Group 1 |
Cohort/Group Label Patients over 50 years of age who underwent surgical treatment in orthopedics and obstetrics and gynecology |
Cohort/Group Description Patients over 50 years of age who underwent surgical treatment at orthopedic, obstetric and gynecologic clinic, will be evaluated for sarcopenia using Korean version of SARC-F Questionnaire (K-SARC-F) , digital hand grip strength measurement. In addition, physical function evaluation will be performed for patients who can walk through short physical performance batteries (Balance tests, Gait seed tests, Chair stand tests) under the supervision of medical staff. After that, body mass and muscle mass are analyzed using a bioelectrical impedence analysis. Six months after the surgery, the outpatient follow-up will be performed again, and the patient's gait ability and daily life are measured at this time. Korean Instrumental Activities of Daily will be measured. |
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Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | Patients 50 years of age or older who underwent surgical treatment at a tertiary medical institution (Chosun University Hospital) orthopedic surgery and obstetrics and gynecology until July 31, 2022 |
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Sampling Method | Simple random sampling, Patients 50 years of age or older who underwent surgical treatment at orthopedic, obstetric and gynecologic clinic until July 31, 2022. |
Condition(s)/Problem(s) |
* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M62.99)Disorder of muscle, unspecified, site unspecified The change in muscle mass is measured before and after orthopedic, obstetric and gynecologic surgery for patients over 50 years expected to have sarcopenia. |
Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 50Year~No Limit |
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Description Patients over 50 years of age who underwent surgical treatment at the Orthopedic, Obstetrics and Gynecologic Clinic until July 31, 2022 after the IRB approval date. |
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Exclusion Criteria |
1. Patients who disagree with participation in this study 2. Patients who do not understand the study themselves 3. Patients unable to walk before surgery |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Not applicable | |
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Primary Outcome(s) 1 | ||
Outcome | height-adjusted Appendicular skeletal muscle mass, body weighted-adjusted skeletal muscle mass, hand grip strength |
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Timepoint | Before and after surgery, 6 months after surgery |
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Secondary Outcome(s) 1 | ||
Outcome | Korean Instrumental Acitivities of Daily Living, Korean version of SARC-F Quesionnaire |
|
Timepoint | Before and after surgery, 6 months after surgery |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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