NCT04123132

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2019

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

January 10, 2020

Status Verified

January 1, 2020

Enrollment Period

4 months

First QC Date

October 9, 2019

Last Update Submit

January 8, 2020

Conditions

Keywords

kinesiophobiametabolic syndromeexercise

Outcome Measures

Primary Outcomes (1)

  • Tampa Kinesiophobia Scale

    People takes between 17-68 total a score. The score of the person shows high kinesiophobia on the scale

    3 months

Study Arms (2)

Patients with metabolic syndrome

Other: Kinesiophobia

Healthy controls

Interventions

The presence of kinesiofobia in patients with metabolic syndrome

Patients with metabolic syndrome

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

45-65 years old men and female with metabolic syndrome and healthy controls

You may qualify if:

  • Patients with metabolic syndrome

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dilek Eker Büyükşireci

Çorum, Central Anatolia, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

KinesiophobiaMetabolic SyndromeMotor Activity

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental DisordersInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Central Study Contacts

Dilek E Büyükşireci

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist doctor

Study Record Dates

First Submitted

October 9, 2019

First Posted

October 10, 2019

Study Start

September 25, 2019

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

January 10, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations