Sarcopenia And Balance In Postmenopausal Osteoporosis

Sponsor
Istanbul Medeniyet University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03832088
Collaborator
(none)
53
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Berg Balance Scale
  • Diagnostic Test: Timed Up and Go Test
  • Diagnostic Test: Jamar hand dynamometer
  • Diagnostic Test: Calf circumference
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
53 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Sarcopenia And Balance In Postmenopausal Osteoporosis
Actual Study Start Date :
Aug 1, 2018
Anticipated Primary Completion Date :
Mar 31, 2019
Anticipated Study Completion Date :
Mar 31, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. sarcopenia in postmenopausal osteoporotic patients [6 months]

    sarcopenia evaluated according to EWGSOP algorithm which includes walking speed, muscle strength and muscle mass measures

  2. balance disorder in postmenopausal osteoporotic patients [6 months]

    balance evaluated by Berg Balance Scale ( 0-56 scored scale , bigger score indicates better balance, scores under 41 indicates bigger risk of falling )

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Medeniyet University Faculty of Medicine, Physical Therapy and Rehabilitation Department Istanbul Turkey 34732

Sponsors and Collaborators

  • Istanbul Medeniyet University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bilinç Doğruöz Karatekin, MD, Research Assistant of PMR, Istanbul Medeniyet University
ClinicalTrials.gov Identifier:
NCT03832088
Other Study ID Numbers:
  • MedeniyetOP
First Posted:
Feb 6, 2019
Last Update Posted:
Feb 21, 2019
Last Verified:
Feb 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bilinç Doğruöz Karatekin, MD, Research Assistant of PMR, Istanbul Medeniyet University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 21, 2019