Clinical trial NCT04749537: Work Productivity and Social Activities In Patients With Ankylosing Spondylitis
Official title: The Relationship Between The Decreasing Activity, Depression And Quality Of Life In Work Productivity And Social Activities In Ankylosing Spondylitis Patients: A Randomized Controlled Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankylosing Spondylitis
Work Productivity
Keywords: Spondylitis
Ankylosing
Quality of Life
Employment
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-02-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For this study, which is planned as a cross-sectional clinical study, 100 patients who were diagnosed with AS between the ages of 18-65 and who applied to the Istanbul Physical Therapy Rehabilitation SUAM Physical Medicine and Rehabilitation Outpatient Clinic between April 15, 2019, and April 15, 2020, and 100 healthy volunteers compatible with age was included.

Brief summary: The aim of this study is to evaluate the relationship between decrease in work productivity and social activities in patients with Ankylosing Spondylitis (AS) with disease activity, depression and quality of life together with demographic data.

Detailed description: For this study, which is planned as a cross-sectional clinical study, 100 patients who were diagnosed with AS between the ages of 18-65 and who applied to the Istanbul Physical Therapy Rehabilitation SUAM Physical Medicine and Rehabilitation Outpatient Clinic between April 15, 2019, and April 15, 2020, and 100 healthy volunteers compatible with age. was included. Demographic data of the participants were recorded. Work productivity and activity reduction questionnaire: general health (WPAI: GH), social role participation questionnaire short form (SRPQ), short form-36 (SF-36), hospital anxiety, and depression scale (HADS), will be evaluated. Besides, if the patient group exists, laboratory results (CRP, erythrocyte sedimentation rate, HLA-B27), and bath ankylosing spondylitis functional index (BASFI), bath ankylosing spondylitis disease activity index (BASDAI), Bath ankylosing spondylitis metrology index (BASMI), visual analog scale (VAS) resting, night and activity values were recorded.

Eligibility criteria: Inclusion Criteria:

* Patients with AS diagnosis between the ages of 18-65
* Healthy volunteer individuals between the ages of 18-65 without known musculoskeletal disease

Exclusion Criteria:

* Those with serious systemic diseases that may interfere with working (respiratory system, cardiovascular system, renal and metabolic diseases)
* Those with orthopedic and psychiatric diseases
* Those with inflammatory diseases other than known AS
* Pregnant
* People with disability due to the history of trauma
* Those with injury after the operation
* Those with diseases that cause neurological sequelae

Primary outcomes:
measure: Work Productivity and Activity Impairment Questionnaire: General Health V2.0 (WPAI:GH)
timeFrame: One day
measure: Social Role Participation Questionnaire (SRPQ)
timeFrame: One day
Secondary outcomes:
measure: Short Form Health Survey 36 (SF-36)
timeFrame: One day
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: One day
measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: One day
measure: Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: One day
measure: Bath Ankylosing Spondylitis Metrology Index (BASMI)
timeFrame: One day
measure: Ankylosing Spondylitis Quality of Life (ASQoL)
timeFrame: One day
measure: Visual Analogue Scale (VAS)
timeFrame: One day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Derya Bugdayci, Assoc Prof
Study officials:
affiliation: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
name: Ömer Faruk Bucak, MD
role: PRINCIPAL_INVESTIGATOR
References:
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