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Effect of Sarcopenia on Postoperative rehabilitation

Status Approved

First Submitted Date

2020/09/21
Registered Date

2020/10/21
Last Updated Date

2021/02/26

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005514
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

Institutional Review Board Information
Board Approval Status	Submitted approval
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 Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific 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 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

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2021-01-14 Actual
Target Number of Participant	100
Primary Completion Date
Study Completion Date
Name of Study	Chosun University Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2021-01-14 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	National Research Foundation
Organization Type	Others
Project ID	2018R1c1B5085

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Chosun University Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
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.

Study Summary Information

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&#39;s gait and daily life after surgery in elderly patients.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
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 1	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.
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
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
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
	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.
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)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Not applicable
Outcome	height-adjusted Appendicular skeletal muscle mass, body weighted-adjusted skeletal muscle mass, hand grip strength
Timepoint	Before and after surgery, 6 months after surgery
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

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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