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Sarcopenia And Balance In Postmenopausal Osteoporosis

Primary Purpose

Osteoporosis, Postmenopausal, Balance; Distorted, Sarcopenia

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Berg Balance Scale
Timed Up and Go Test
Jamar hand dynamometer
Calf circumference
Sponsored by
Istanbul Medeniyet University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Osteoporosis, Postmenopausal focused on measuring osteoporosis, sarcopenia, balance disorder

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Having postmenopausal osteoporosis
  • No other disease that can cause balance disorder
  • Volunteer participation in the study

Exclusion Criteria:

  • To have a disease that will cause balance disorder,
  • Having understanding problem to prevent communication with the patient,
  • The lack of motor function to the balance device.

Sites / Locations

  • Istanbul Medeniyet University Faculty of Medicine, Physical Therapy and Rehabilitation DepartmentRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

postmenopausal osteoporosis

Arm Description

Postmenopausal osteoporotic patients evaluated for sarcopenia and balance disorders

Outcomes

Primary Outcome Measures

sarcopenia in postmenopausal osteoporotic patients
sarcopenia evaluated according to EWGSOP algorithm which includes walking speed, muscle strength and muscle mass measures
balance disorder in postmenopausal osteoporotic patients
balance evaluated by Berg Balance Scale ( 0-56 scored scale , bigger score indicates better balance, scores under 41 indicates bigger risk of falling )

Secondary Outcome Measures

Full Information

First Posted
February 2, 2019
Last Updated
February 19, 2019
Sponsor
Istanbul Medeniyet University
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1. Study Identification

Unique Protocol Identification Number
NCT03832088
Brief Title
Sarcopenia And Balance In Postmenopausal Osteoporosis
Official Title
Sarcopenia And Balance In Postmenopausal Osteoporosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
March 31, 2019 (Anticipated)
Study Completion Date
March 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medeniyet University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study was performed on 53 postmenopausal osteoporosis patients who presented to our osteoporosis outpatient clinic. Following written informed consent, patients were evaluated for sarcopenia according to the sarcopenia algorithm proposed by the European Working Group on Sarcopenia in Older People (EWGSOP). Algorithm parameters were walking speed, muscle strength and muscle mass measurements. We used Timed Up and Go Test (TUG) for evaluation of walking speed, Jamar Hand Dynamometer for muscle strength assessment, and calf circumference for muscle mass measurement. Balances of the patients were evaluated with Berg Balance Scale (BBS) and functional skills were evaluated with the Timed Up and Go Test (TUG). Other clinical parameters (age, body mass index (BMI), 25OHvitD level, menopause age, fall within the last year, fracture history, history of fracture in mother) were questioned.
Detailed Description
The study was performed on 53 postmenopausal osteoporosis patients who presented to our osteoporosis outpatient clinic. Following written informed consent, patients were evaluated for sarcopenia according to the sarcopenia algorithm proposed by the European Working Group on Sarcopenia in Older People (EWGSOP). Algorithm parameters were walking speed, muscle strength and muscle mass measurements. We used Timed Up and Go Test (TUG) for evaluation of walking speed, Jamar Hand Dynamometer for muscle strength assessment, and calf circumference for muscle mass measurement. Balances of the patients were evaluated with Berg Balance Scale (BBS) and functional skills were evaluated with the Timed Up and Go Test (TUG). Other clinical parameters (age, body mass index (BMI), 25OHvitD level, menopause age, fall within the last year, fracture history, history of fracture in mother) were questioned. SPSS 22.0 program will be used for statistical evaluation and correlation analysis will be done.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Postmenopausal, Balance; Distorted, Sarcopenia
Keywords
osteoporosis, sarcopenia, balance disorder

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
postmenopausal osteoporosis
Arm Type
Experimental
Arm Description
Postmenopausal osteoporotic patients evaluated for sarcopenia and balance disorders
Intervention Type
Diagnostic Test
Intervention Name(s)
Berg Balance Scale
Intervention Description
Berg Balance Scale performed for balance disorder
Intervention Type
Diagnostic Test
Intervention Name(s)
Timed Up and Go Test
Intervention Description
Timed Up and Go Test for walking speed
Intervention Type
Diagnostic Test
Intervention Name(s)
Jamar hand dynamometer
Intervention Description
Jamar hand dynamometer for grip strength which correlates with muscle strength of patient
Intervention Type
Diagnostic Test
Intervention Name(s)
Calf circumference
Intervention Description
Calf circumference for muscle mass evaluation. Calf circumference is an anthropometric measurement which correlates with muscle mass.
Primary Outcome Measure Information:
Title
sarcopenia in postmenopausal osteoporotic patients
Description
sarcopenia evaluated according to EWGSOP algorithm which includes walking speed, muscle strength and muscle mass measures
Time Frame
6 months
Title
balance disorder in postmenopausal osteoporotic patients
Description
balance evaluated by Berg Balance Scale ( 0-56 scored scale , bigger score indicates better balance, scores under 41 indicates bigger risk of falling )
Time Frame
6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Postmenopausal osteoporotic patients
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Having postmenopausal osteoporosis No other disease that can cause balance disorder Volunteer participation in the study Exclusion Criteria: To have a disease that will cause balance disorder, Having understanding problem to prevent communication with the patient, The lack of motor function to the balance device.
Facility Information:
Facility Name
Istanbul Medeniyet University Faculty of Medicine, Physical Therapy and Rehabilitation Department
City
Istanbul
ZIP/Postal Code
34732
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bilinç Doğruöz Karatekin
Phone
+905368308709
Email
bilincdogruoz@hotmail.com
First Name & Middle Initial & Last Name & Degree
Bilinç Doğruöz Karatekin, MD
First Name & Middle Initial & Last Name & Degree
Afitap İçağasıoğlu, MD, Prof
First Name & Middle Initial & Last Name & Degree
Yasemin Yumuşakhuylu, MD, Ass. Prof
First Name & Middle Initial & Last Name & Degree
Fethullah Bayram, MD
First Name & Middle Initial & Last Name & Degree
Şeyhmus Yaşin, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Sarcopenia And Balance In Postmenopausal Osteoporosis

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