Clinical trial NCT06520709: Kinesiophobia in Postmenopausal Osteoporosis
Official title: Kinesiophobia and Associated Factors in Postmenopausal Osteoporosis: A Controlled Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Keywords: osteoporosis
quality of life
kinesiophobia
depression
anxiety
Lead sponsor: Beylikduzu State Hospital
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 60
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

Brief summary: 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Tampa Scale for Kinesiophobia (TSK)
timeFrame: 0 day
Secondary outcomes:
measure: Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41)
timeFrame: 0 day
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 0 day
measure: Tinetti Falls Efficacy Scale (TFES)
timeFrame: 0 day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Beylikdüzü State Hospital
Study officials:
References: