Sarcopenia And Balance In Postmenopausal Osteoporosis

Sarcopenia Clinical Trial

Official title:

Sarcopenia And Balance In Postmenopausal Osteoporosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03832088
• Other study ID #: MedeniyetOP
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: February 2019
• Source: Istanbul Medeniyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 53
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Balance; Distorted
• Osteoporosis
• Osteoporosis, Postmenopausal
• Sarcopenia

Intervention

Diagnostic Test:
• Berg Balance Scale
Berg Balance Scale performed for balance disorder
• Timed Up and Go Test
Timed Up and Go Test for walking speed
• Jamar hand dynamometer
Jamar hand dynamometer for grip strength which correlates with muscle strength of patient
• Calf circumference
Calf circumference for muscle mass evaluation. Calf circumference is an anthropometric measurement which correlates with muscle mass.

Locations

Country	Name	City	State
Turkey	Istanbul Medeniyet University Faculty of Medicine, Physical Therapy and Rehabilitation Department	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sarcopenia in postmenopausal osteoporotic patients	sarcopenia evaluated according to EWGSOP algorithm which includes walking speed, muscle strength and muscle mass measures	6 months
Primary	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 )	6 months