OsteoporosisNCT06520709
Kinesiophobia in Postmenopausal Osteoporosis
An observational study of Osteoporosis, run by Beylikduzu State Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Osteoporosis
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jan 2024to 21 Feb 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Osteoporosis
- Being tested
- No intervention
- Keywords
- osteoporosis, quality of life, kinesiophobia, depression, anxiety
- Medical subject headings
- Osteoporosis, Kinesiophobia, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Postmenopausal osteoporosis | Postmenopausal osteoporosis Receives: Other: No intervention | |
| Control group | Healthy group Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 day
Secondary outcomes (3)
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
Measured: 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.
Measured: 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.
Measured: 0 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start21 Jan 2024
- Primary completion21 Feb 2024
- Study completion21 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Beylikduzu State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Sirin, Beylikduzu State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520709
- Sponsor's protocol ID
- BeylikduzuStateH1
- Status last verified
- Jul 2024
- First submitted
- 20 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinesiophobia and Associated Factors in Postmenopausal Osteoporosis: A Controlled Study
- ClinicalTrials.gov ID
- NCT06520709
- Acronym / sponsor ID
- BeylikduzuStateH1
- Conditions
- Osteoporosis
- Keywords
- osteoporosis, quality of life, kinesiophobia, depression, anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Beylikduzu State HospitalUniversity, hospital or other
- Study start
- 21 Jan 2024 (actual)
- Primary completion
- 21 Feb 2024 (actual)
- Study completion
- 21 Feb 2024 (actual)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postmenopausal osteoporosis | – | Other: No interventionPostmenopausal osteoporosis |
| Control group | – | Other: No interventionHealthy group |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Control group, Postmenopausal osteoporosis |
Primary outcome
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.
3 secondary outcomes
Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41)
Time frame: 0 day
Hospital Anxiety and Depression Scale (HADS)
Time frame: 0 day
Tinetti Falls Efficacy Scale (TFES)
Time frame: 0 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by Beylikduzu State Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tampa Scale for Kinesiophobia (TSK) (time frame: 0 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024; AzTrials last refreshed its copy on 1 Nov 2026.