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Evaluation of Kinesophobia in Patients With Metabolic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04123132
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : January 10, 2020
Sponsor:
Information provided by (Responsible Party):
Dilek Eker Büyükşireci, Erol Olcok Corum Training and Research Hospital

Brief Summary:

Metabolic syndrome (MS) is a public health problem characterized by central obesity, increased blood pressure and triglyceride levels, decreased blood HDL levels and the presence of insulin resistance (1).Kinesiophobia is a fear of irrational movement that develops because of its belief in susceptibility to injury and is associated with low levels of physical activity. Considering that exercise improves metabolic processes in people with MS, we aimed to evaluate the presence of kinesophobia in patients with MS.

Patients aged 45-65 years diagnosed with metabolic syndrome and healthy controls will be included in the study. Patients with rheumatic and neurological diseases,history of trauma, gonarthrosis, lumbar disc hernia, previous fractures, fibromyalgia and those who have experienced pain for the last week will be excluded. The participants will be filled in the Short Form-36 (SF-36), the Hospital Anxiety and Depression Scale, and the Tampa Kinesiophobia Scale. 48 patients with MS and 48 healthy participants will be included in the study.


Condition or disease Intervention/treatment
Kinesiophobia Metabolic Syndrome Other: Kinesiophobia

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Study Type : Observational
Estimated Enrollment : 96 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Evaluation of Kinesophobia in Patients With Metabolic Syndrome
Actual Study Start Date : September 25, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with metabolic syndrome Other: Kinesiophobia
The presence of kinesiofobia in patients with metabolic syndrome

Healthy controls



Primary Outcome Measures :
  1. Tampa Kinesiophobia Scale [ Time Frame: 3 months ]
    People takes between 17-68 total a score. The score of the person shows high kinesiophobia on the scale



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
45-65 years old men and female with metabolic syndrome and healthy controls
Criteria

Inclusion Criteria:

  • Patients with metabolic syndrome

Exclusion Criteria:

  • Patients with rheumatic disease
  • Patients with neurologic disease
  • Patients with history of trauma
  • Patients with gonartrosis
  • Pateints with fibromialgia

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): NCT04123132


Contacts
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Contact: Dilek E Büyükşireci +905439196253 dilekeker55@gmail.com

Locations
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Turkey
Dilek Eker Büyükşireci Recruiting
Çorum, Central Anatolia, Turkey
Contact: Dilek E Büyükşireci    5439196253    dilekeker55@gmail.com   
Contact: Dilek E Büyükşireci    +905439196253    dilekeker55@gmail.com   
Sponsors and Collaborators
Erol Olcok Corum Training and Research Hospital

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Responsible Party: Dilek Eker Büyükşireci, Specialist doctor, Erol Olcok Corum Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04123132    
Other Study ID Numbers: 08090081DEB
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: January 10, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Dilek Eker Büyükşireci, Erol Olcok Corum Training and Research Hospital:
kinesiophobia
metabolic syndrome
exercise
Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases