Systemic Sclerosis (SSc)NCT06594302
Functional Performance and Biopsychosocial Characteristics in Individuals with Systemic Sclerosis
An observational study of Systemic Sclerosis (SSc), run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Sclerosis (SSc)
- What is being tested?
- Functional performance tests and scales measuring biopsychosocial characteristics
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Oct 2023to 4 Oct 2025
- How long will I take part?
- 2 Weeks
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of individuals who come to the university hospital for routine controls.
Who may be able to join
- Being diagnosed with Systemic Sclerosis
- To be between 18-65 years old
- Being reader literate
Who cannot join
- Having a severe musculoskeletal disability
- Being diagnosed with pulmonary hypertension
- History of active infection
- Having a severe neuropsychiatric disorder
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Ankara, Altındağ, 06100
Orkun Tüfekçi, PT, PhD(c), +90 312 305 25 25, orkuntf@gmail.com
About this study
Official title: The Relationship Between Functional Performance and Biopsychosocial Characteristics in Individuals with Systemic Sclerosis
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.
Read more
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)
- Being tested
- Functional performance tests and scales measuring biopsychosocial characteristics
- Keywords
- functionality, quality of life, biopsychosocial model, BETY-BQ, functional performance, systemic sclerosis
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional performance tests and scales measuring biopsychosocial characteristicsOther
Functional performance tests and scales applications
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: Baseline
Secondary outcomes (14)
Modified Rodnan Skin Score (mRSS)
It is a standard disease activity scoring applied in doctor\'s examinations for Systemic Sclerosis patients. It evaluates the skin hardness of 17 different parts of the body. 0= normal skin , 1= mild skin thickness, 2= moderate skin thickness, 3= severe skin thickness. A high score indicates increased skin thickness. The total score is scored between 0-5.
Measured: Baseline
Modified Hand Mobility in Scleroderma (mHAMIS)
It is a method in which a physiotherapist evaluates the hand functions of individuals. Based on observation, it evaluates four different hand functions (finger flexion, finger extension, finger abduction, and dorsal extension of the hand).
Measured: Baseline
Hospital Anxiety and Depression Scale (HADS)
It consists of 14 items, 7 of which assess anxiety, and the other 7 determine depression. Each item is scored between 0 and 3, and the total is scored between 0 and 21. High scores indicate poor anxiety and depression levels.
Measured: Baseline
Duruoz Hand Index
Questionnaire form-18 is a likert-type scale that evaluates different hand functions. It can score between 0-90. A high score means a low hand functions.
Measured: Baseline
Short Form-36 (SF-36)
It is a 36-item, 11-question scale that allows general health screening with eight sub-parameters consisting of general health, physical function, social function, pain, emotional well-being, role limitations due to physical health, role limitations due to emotional problems, and vitality. It is a generic scale; Items are scored as \'0 = worst health condition, 100 = best health state\'. Each subcategory is scored between 0 and 100 points, with a high score indicating good health.
Measured: Baseline
Chronic Disease Self-Management Scale
The scale, which evaluates the self-management status of the individual with chronic disease, consists of 4 sub-dimensions and 21 items, including Self-Stigmatisation (7 items), Coping with Stigmatisation (5 items), Health Care Effectiveness (5 items) and Treatment Compliance (4 items). The rating of the items in the measurement tool is 1= Never, 2= Rarely, 3= Average, 4= Quite often, and 5= Always.
Measured: Baseline
Exercise Self-Efficacy Scale
The scale consists of 18 items rated from 0% to a maximum power of 100% according to the individual\'s self-efficacy for exercise. Participants will record the strength of their efficacy beliefs according to the 100-point scale with 10-unit intervals from 0 (cannot do it) to 50 (moderately able to do it) and 100 (absolutely able to do it).
Measured: Baseline
Brief Illness Perception. Questionnaire
It consists of nine items that express illness perception\'s cognitive and emotional representation. In the first eight items, a representation expression related to illness perception is questioned, and each item consists of open-ended answers with a score between 0 and 10. In the last item, the individual is asked to indicate three factors that cause their illness.
Measured: Baseline
Body Awareness Questionnaire
The sensitivity of the individual to normal or abnormal body sensitivity to physical, emotional, and social elements is questioned about sensitivity to physical reactions. The 18-item scale consists of four subgroups (estimation of body reactions, sleep-wake cycle, estimation at the beginning, and attention to changes and responses in the body process). For each of the 18 items, respondents are asked to score between 1 and 7 (1=Not true for me at all, 7=Very true for me). The total score from the questionnaire can be a maximum of 126 and a minimum of 18.
Measured: Baseline
Tampa Scale of Kinesiophobia (TSK)
This consists of 17 statements that assess the subjective rating of kinesiophobia. Statements are rated on a four-point Likert scale from 'strongly disagree' (score 1) to 'strongly agree' (score 4). Four items (4, 8, 11, and 12) are reverse-scored. The total score ranges from 17 to 68, with higher values indicating more severe kinesiophobia.
Measured: Baseline
Central Sensitisation Inventory
It consists of 25 questions evaluating the symptoms associated with central sensitization in 2 parts. Part A of the scale includes questions about symptoms scored between 0-4, and a score above 40 indicates the development of central sensitization. Part B of the scale (no scoring) questions whether the patient has previously received any diagnosis related to one or more central nervous systems.
Measured: Baseline
Five Times Sit to-Stand Test
Assesses lower limb and body strength, power, agility, and ability to get up from a chair and sit down again. The patient sits on a chair with back support and crosses their arms in front of the chest. The patient is asked to stand up and sit down five times as quickly as possible without support from the arms. The time required for five repetitions to sit and stand up is recorded in seconds.
Measured: Baseline
Timed Up and Go Test
The balance status of the individual is evaluated by getting up from a back-supported chair and walking 3 meters at a normal walking speed and returning to the chair and the time of sitting on the chair is measured and recorded in seconds.
Measured: Baseline
Stair Climb Test
To measure the individual^s lower extremity strength and dynamic balance, the time to ascend and descend a 10-step staircase with a handrail in the range of 16-20 cm as fast as possible is recorded in seconds.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start4 Oct 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion4 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Sclerosis (SSc)Studies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orkun Tüfekçi, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594302
- Sponsor's protocol ID
- SBA 23/171
- Status last verified
- Sep 2024
- First submitted
- 8 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will not be shared to protect the data of individuals
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Functional Performance and Biopsychosocial Characteristics in Individuals with Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT06594302
- Acronym / sponsor ID
- SBA 23/171
- Conditions
- Systemic Sclerosis (SSc)
- Keywords
- functionality, quality of life, biopsychosocial model, BETY-BQ, functional performance, systemic sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 4 Oct 2025 (estimated)
- First posted
- 19 Sep 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of individuals who come to the university hospital for routine controls.
Key inclusion criteria (3 listed)
- Being diagnosed with Systemic Sclerosis
- To be between 18-65 years old
- Being reader literate
Key exclusion criteria (5 listed)
- Having a severe musculoskeletal disability
- Being diagnosed with pulmonary hypertension
- History of active infection
- Having a severe neuropsychiatric disorder
- Pregnancy
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 |
|---|---|---|
| Functional performance tests and scales measuring biopsychosocial characteristicsFunctional performance tests and scales applications | Other | – |
Primary outcome
BETY-Biopsychosocial Questionnaire
Time frame: Baseline
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
Scleroderma Health Assessment Questionnaire (SHAQ)
Time frame: Baseline
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.
6-Minute Walk Test-Borg Scale
Time frame: Baseline
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.
14 secondary outcomes
Modified Rodnan Skin Score (mRSS)
Time frame: Baseline
Modified Hand Mobility in Scleroderma (mHAMIS)
Time frame: Baseline
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline
Duruoz Hand Index
Time frame: Baseline
Short Form-36 (SF-36)
Time frame: Baseline
Chronic Disease Self-Management Scale
Time frame: Baseline
Exercise Self-Efficacy Scale
Time frame: Baseline
Brief Illness Perception. Questionnaire
Time frame: Baseline
Body Awareness Questionnaire
Time frame: Baseline
Tampa Scale of Kinesiophobia (TSK)
Time frame: Baseline
Central Sensitisation Inventory
Time frame: Baseline
Five Times Sit to-Stand Test
Time frame: Baseline
Timed Up and Go Test
Time frame: Baseline
Stair Climb Test
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. Will not be shared to protect the data of individuals
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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.
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 Systemic Sclerosis (SSc), run by Hacettepe University 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 5 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: status not confirmed, as of the sponsor's last update on 19 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Orkun Tüfekçi, PT, PhD(c) (5319502648, orkuntf@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BETY-Biopsychosocial Questionnaire (time frame: Baseline). The study lists 3 primary outcomes in all. 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 19 Sep 2024.