Clinical trial NCT06594302: Functional Performance and Biopsychosocial Characteristics in Individuals with Systemic Sclerosis
Official title: The Relationship Between Functional Performance and Biopsychosocial Characteristics in Individuals with Systemic Sclerosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Systemic Sclerosis (SSc)
Keywords: functionality
quality of life
biopsychosocial model
BETY-BQ
functional performance
systemic sclerosis
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of individuals who come to the university hospital for routine controls.

Brief summary: In individuals with systemic sclerosis (SSc), the loss of functionality severely affects quality of life. This condition may cause psychosocial effects by affecting the person, their family, and the environment. Activities of daily living, quality of life, and psychosocial well-being are affected, and aesthetic concerns arise.

Different scales evaluating the quality of life, functions, and disease characteristics of individuals diagnosed with SSc are accepted. In this field, modified Rodnan skin score (mRDS), Duruöz hand index (DHI), scleroderma health assessment questionnaire (SHAQ), and Short Form-36 (SF-36) are frequently used. The BETY-Biopsychosocial Questionnaire is also included in the literature for the evaluation of the biopsychosocial effects of individuals with rheumatism.

In addition, it is essential to evaluate the characteristics of individuals who maintain their health with chronic diseases. Therefore, assessment parameters such as the Chronic Disease Self-Management Scale, Exercise Self-Efficacy Scale, Short Form Illness Perception Scale, Body Awareness Questionnaire, Central Sensitisation Scale, and Tampa Kinesiophobia Questionnaire are frequently used in this regard. The 6 Minute Walk Test (6 MWT) is recommended as a frequently used method to determine cardiopulmonary endurance in individuals with SSc.

It is known that there is a decrease in the distance walked in this test compared to healthy individuals, and the fall potential of physical performance is an important parameter.

In addition, there are also methods used to evaluate physical performance, such as the five-repetition sit-and-stand test (CST), the Stair Climbing Test (SCT), and the Timed up-and-go test (TUG). Considering all these effects, there is a need to examine the relationship between functional and biopsychosocial impact in individuals with SSc.

This study aims to examine the relationship between functional performance and biopsychosocial characteristics in individuals diagnosed with systemic sclerosis and to present the results for this disease group.


Eligibility criteria: Inclusion Criteria:

* Being diagnosed with Systemic Sclerosis
* To be between 18-65 years old
* Being reader literate

Exclusion Criteria:

* Having a severe musculoskeletal disability
* Being diagnosed with pulmonary hypertension
* History of active infection
* Having a severe neuropsychiatric disorder
* Pregnancy

Primary outcomes:
measure: BETY-Biopsychosocial Questionnaire
timeFrame: Baseline
measure: Scleroderma Health Assessment Questionnaire (SHAQ)
timeFrame: Baseline
measure: 6-Minute Walk Test-Borg Scale
timeFrame: Baseline
Secondary outcomes:
measure: Modified Rodnan Skin Score (mRSS)
timeFrame: Baseline
measure: Modified Hand Mobility in Scleroderma (mHAMIS)
timeFrame: Baseline
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline
measure: Duruoz Hand Index
timeFrame: Baseline
measure: Short Form-36 (SF-36)
timeFrame: Baseline
measure: Chronic Disease Self-Management Scale
timeFrame: Baseline
measure: Exercise Self-Efficacy Scale
timeFrame: Baseline
measure: Brief Illness Perception. Questionnaire
timeFrame: Baseline
measure: Body Awareness Questionnaire
timeFrame: Baseline
measure: Tampa Scale of Kinesiophobia (TSK)
timeFrame: Baseline
measure: Central Sensitisation Inventory
timeFrame: Baseline
measure: Five Times Sit to-Stand Test
timeFrame: Baseline
measure: Timed Up and Go Test
timeFrame: Baseline
measure: Stair Climb Test
timeFrame: Baseline
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Altındağ
Study officials:
References: