Functional Performance and Biopsychosocial Characteristics in Individuals with Systemic Sclerosis

NCT06594302 | Recruiting

• 1 other identifier: SBA 23/171
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Sclerosis (SSc)

Keywords

functionality; quality of life; biopsychosocial model; BETY-BQ; functional performance; systemic sclerosis

Outcome Measures

Primary Outcomes (3)

• BETY-Biopsychosocial Questionnaire

  The biopsychosocial status of the individual is assessed with questions about pain, functionality, mood, sociability, sexuality, and sleep status. Each question consists of 30 items scored between 0-120 as '0 (never), 1 (yes rarely), 2 (yes sometimes), 3 (yes often), 4 (yes always)'. A high score indicates poor biopsychosocial status

  Baseline

• Scleroderma Health Assessment Questionnaire (SHAQ)

  It is a scale that evaluates the functionality of individuals diagnosed with systemic sclerosis with a 15 cm long VAS with five complaints about the disease and 20 questions. The total score is scored between 0-3. A high score indicates poor functionality.

  Baseline

• 6-Minute Walk Test-Borg Scale

  To assess the submaximal aerobic capacity of individuals, they will walk for 6 minutes over a distance of 30 meters. The total distance walked in 6 minutes will be recorded in meters. Pulse rate, blood pressure, and oxygen saturation values will be checked before and after the test for the safety of the patients.

  Baseline

Secondary Outcomes (14)

• Modified Rodnan Skin Score (mRSS)

  Baseline

• Modified Hand Mobility in Scleroderma (mHAMIS)

  Baseline

• Hospital Anxiety and Depression Scale (HADS)

  Baseline

• Duruoz Hand Index

  Baseline

• Short Form-36 (SF-36)

  Baseline

Interventions

Functional performance tests and scales measuring biopsychosocial characteristics OTHER

Functional performance tests and scales applications

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will consist of individuals who come to the university hospital for routine controls.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Altındağ, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Central Study Contacts

Orkun Tüfekçi, PT, PhD(c)

CONTACT

5319502648; orkuntf@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PT, PhD(c)

Study Record Dates

• First Submitted: September 8, 2024
• First Posted: September 19, 2024
• Study Start: October 4, 2023
• Primary Completion: December 31, 2024
• Study Completion: October 4, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)