Kinesiophobia in Postmenopausal Osteoporosis

Kinesiophobia and Associated Factors in Postmenopausal Osteoporosis: A Controlled Study

This study aims to evaluate kinesiophobia levels in postmenopausal women with osteoporosis compared to a healthy control group and to explore the relationships between kinesiophobia and various psychosocial factors, including quality of life, fear of falling, and symptoms of depression and anxiety.

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Other: No intervention

Detailed Description

This cross-sectional, controlled study aims to explore kinesiophobia levels in postmenopausal women with osteoporosis compared to healthy age-matched controls. Postmenopausal osteoporosis is a systemic condition characterized by reduced bone mineral density, which increases fracture risk and can significantly affect individuals' physical activity and overall quality of life. Kinesiophobia, or the irrational fear of movement due to perceived injury risk, can further exacerbate this issue by restricting physical activity, which is vital for maintaining bone health. The study will involve 60 postmenopausal women diagnosed with osteoporosis and 60 healthy age-matched women without osteoporosis or osteopenia. Participants will be recruited from the outpatient clinics of İstanbul Physical Therapy and Rehabilitation Training and Research Hospital between January 21, 2024, and February 21, 2024. The study will assess kinesiophobia using the Turkish version of the Tampa Scale for Kinesiophobia (TSK), quality of life with the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41), and symptoms of depression and anxiety using the Hospital Anxiety and Depression Scale (HADS). Additionally, the Tinetti Falls Efficacy Scale (TFES) will evaluate fear of falling, and bone mineral density will be measured using dual-energy X-ray absorptiometry (DXA).

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34147
    • Beylikdüzü State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Osteoporosis Group: This group included 60 postmenopausal women diagnosed with osteoporosis. Participants were required to have been under follow-up for at least six months.

Control Group: This group comprised 60 healthy postmenopausal women who were neither osteoporotic nor osteopenic

Description

Inclusion Criteria:

• Diagnosis: Participants must be diagnosed with postmenopausal osteoporosis and have been under follow-up for at least six months.
• Age: Individuals must be 50 years or older.
• Health Status: Participants must have excluded secondary causes of osteoporosis.

Exclusion Criteria:

• Comorbid Conditions: Presence of other musculoskeletal, neurological, or psychiatric diseases that could influence kinesiophobia or pain.
• Cognitive or Communication Difficulties: Any cognitive dysfunction or communication issues that might impair the participant's ability to engage with the study.
• Acute Conditions: Presence of acute painful conditions that might affect the results.
• Medications: Use of medications or presence of diseases that could cause balance or functional disorders.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Postmenopausal osteoporosis	Other: No intervention; No intervention
Control group; Healthy group	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tampa Scale for Kinesiophobia (TSK)	The Tampa Scale for Kinesiophobia (TSK) is a widely used tool for assessing fear of movement and physical activity, often referred to as kinesiophobia.	0 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41)	The Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41) is a comprehensive instrument specifically designed to assess the quality of life in individuals with osteoporosis	0 day
Hospital Anxiety and Depression Scale (HADS)	The Hospital Anxiety and Depression Scale (HADS) is a widely used tool for assessing levels of anxiety and depression in patients, particularly in medical settings.	0 day
Tinetti Falls Efficacy Scale (TFES)	The Tinetti Falls Efficacy Scale (TFES) is a tool designed to assess an individual's fear of falling and their perceived confidence in their ability to perform various activities without falling.	0 day

Collaborators and Investigators

• Sponsor: Beylikduzu State Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2024
• Primary Completion (Actual): February 21, 2024
• Study Completion (Actual): February 21, 2024

Study Registration Dates

• First Submitted: July 20, 2024
• First Submitted That Met QC Criteria: July 20, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): July 25, 2024
• Last Update Submitted That Met QC Criteria: July 20, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; depression; anxiety; osteoporosis; kinesiophobia
• Additional Relevant MeSH Terms: Mental Disorders; Metabolic Diseases; Musculoskeletal Diseases; Anxiety Disorders; Bone Diseases; Bone Diseases, Metabolic; Phobic Disorders; Osteoporosis; Osteoporosis, Postmenopausal; Kinesiophobia
• Other Study ID Numbers: BeylikduzuStateH1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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