NCT06520709

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 25, 2024

Completed
Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

1 month

First QC Date

July 20, 2024

Last Update Submit

July 20, 2024

Conditions

Keywords

osteoporosisquality of lifekinesiophobiadepressionanxiety

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

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

    0 day

  • Hospital Anxiety and Depression Scale (HADS)

    0 day

  • Tinetti Falls Efficacy Scale (TFES)

    0 day

Study Arms (2)

Postmenopausal osteoporosis

Postmenopausal osteoporosis

Other: No intervention

Control group

Healthy group

Other: No intervention

Interventions

No intervention

Control groupPostmenopausal osteoporosis

Eligibility Criteria

Age50 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beylikdüzü State Hospital

Istanbul, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

OsteoporosisKinesiophobiaDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPhobic DisordersMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 20, 2024

First Posted

July 25, 2024

Study Start

January 21, 2024

Primary Completion

February 21, 2024

Study Completion

February 21, 2024

Last Updated

July 25, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations