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Completed

NCT Number: NCT06520709

Kinesiophobia in Postmenopausal Osteoporosis

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.

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Key information

Age range

50 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Beylikdüzü State Hospital

Istanbul, 34147, Turkey (Türkiye)

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Tampa Scale for Kinesiophobia (TSK)

    Time frame: 0 day

    The Tampa Scale for Kinesiophobia (TSK) is a widely used tool for assessing fear of movement and physical activity, often referred to as kinesiophobia.

Secondary outcomes

  1. Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41)

    Time frame: 0 day

    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

  2. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 0 day

    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.

  3. Tinetti Falls Efficacy Scale (TFES)

    Time frame: 0 day

    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.

Sponsors and collaborators

Lead sponsor

Beylikduzu State Hospital

Other

Registry information

Official study title

Kinesiophobia and Associated Factors in Postmenopausal Osteoporosis: A Controlled Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 25, 2024
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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