Sarcopenia And Balance In Postmenopausal Osteoporosis

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.

Study Overview

• Status: Unknown
• Conditions: Sarcopenia; Osteoporosis, Postmenopausal; Balance; Distorted
• Intervention / Treatment: Diagnostic test: Berg Balance Scale; Diagnostic test: Timed Up and Go Test; Diagnostic test: Jamar hand dynamometer; Diagnostic test: Calf circumference

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.

• Study Type: Interventional
• Enrollment (Anticipated): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34732
    • Recruiting
    • Istanbul Medeniyet University Faculty of Medicine, Physical Therapy and Rehabilitation Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: postmenopausal osteoporosis; Postmenopausal osteoporotic patients evaluated for sarcopenia and balance disorders

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sarcopenia in postmenopausal osteoporotic patients	sarcopenia evaluated according to EWGSOP algorithm which includes walking speed, muscle strength and muscle mass measures	6 months
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

Collaborators and Investigators

• Sponsor: Istanbul Medeniyet University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2018
• Primary Completion (ANTICIPATED): March 31, 2019
• Study Completion (ANTICIPATED): March 31, 2019

Study Registration Dates

• First Submitted: February 2, 2019
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (ACTUAL): February 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 21, 2019
• Last Update Submitted That Met QC Criteria: February 19, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: osteoporosis; sarcopenia; balance disorder
• Additional Relevant MeSH Terms: Metabolic Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Bone Diseases; Muscular Atrophy; Atrophy; Bone Diseases, Metabolic; Sarcopenia; Osteoporosis; Osteoporosis, Postmenopausal
• Other Study ID Numbers: MedeniyetOP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No