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Sarcopenia And Balance In Postmenopausal Osteoporosis

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ClinicalTrials.gov Identifier: NCT03832088
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Bilinç Doğruöz Karatekin, Istanbul Medeniyet University

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
Osteoporosis, Postmenopausal Balance; Distorted Sarcopenia Diagnostic Test: Berg Balance Scale Diagnostic Test: Timed Up and Go Test Diagnostic Test: Jamar hand dynamometer Diagnostic Test: Calf circumference Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Sarcopenia And Balance In Postmenopausal Osteoporosis
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

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.




Primary Outcome Measures :
  1. sarcopenia in postmenopausal osteoporotic patients [ Time Frame: 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 [ Time Frame: 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 )



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Postmenopausal osteoporotic patients
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03832088


Locations
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Turkey
Istanbul Medeniyet University Faculty of Medicine, Physical Therapy and Rehabilitation Department Recruiting
Istanbul, Turkey, 34732
Contact: Bilinç Doğruöz Karatekin    +905368308709    bilincdogruoz@hotmail.com   
Principal Investigator: Bilinç Doğruöz Karatekin, MD         
Sub-Investigator: Afitap İçağasıoğlu, MD, Prof         
Sub-Investigator: Yasemin Yumuşakhuylu, MD, Ass. Prof         
Sub-Investigator: Fethullah Bayram, MD         
Sub-Investigator: Şeyhmus Yaşin, MD         
Sponsors and Collaborators
Istanbul Medeniyet University

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Responsible Party: Bilinç Doğruöz Karatekin, MD, Research Assistant of PMR, Istanbul Medeniyet University
ClinicalTrials.gov Identifier: NCT03832088    
Other Study ID Numbers: MedeniyetOP
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bilinç Doğruöz Karatekin, Istanbul Medeniyet University:
osteoporosis
sarcopenia
balance disorder
Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Sarcopenia
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms