Systemic SclerosisNCT05453071
The Effect of Cognitive Exercise Therapy Approach in Individuals With Systemic Sclerosis
A study testing Cognitive Exercise Therapy Approach (BETY) in people with Systemic Sclerosis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effects of Cognitive Exercise Therapy Approach (BETY) on vascularization, muscle strength, functionality, anti-inflammatory and biopsychosocial status in individuals with systemic sclerosis and to present a named exercise model for this disease group with objective results. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Cognitive Exercise Therapy Approach (BETY)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2022to 2 Nov 2022
- Phase
- Interventional
- 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
Who may be able to join
- Having been diagnosed with Systemic Sclerosis
- Being between the ages of 18-65
- Regular attendance at the rheumatology outpatient clinic at Hacettepe University
- No medication change in the last 3 months
Who cannot join
- Having a severe musculoskeletal disability Being diagnosed with pulmonary hypertension
- FVC value below 50%
- History of active infection
- Symptomatic cardiac involvement
- Having a psychiatric disorder
- Pregnancy
Show all 9Show fewer
- History of active myositis
- Renal failure
- Not being literate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Cognitive Exercise Therapy Approach on Vascularization, Muscle Strength, Functionality, Anti-Inflammatory and Biopsycosocial Status in Individuals With Systemic Sclerosis
The aim of this study is to investigate the effects of Cognitive Exercise Therapy Approach (BETY) on vascularization, muscle strength, functionality, anti-inflammatory and biopsychosocial status in individuals with systemic sclerosis and to present a named exercise model for this disease group with objective results.
Read the detailed description
Systemic sclerosis is an inflammatory and chronic autoimmune disease. Systemic sclerosis, which was first defined by Hippocrates as thickened skin, can also progress with skin involvement and fibrosis of internal organs. Although the exact pathogenesis of the disease is not understood, it is thought to occur as a result of interactions between factors affecting collagen synthesis, fibrosis, capillary (vasculopathy) changes and immunological mechanisms. The role of inflammation has an important place in the pathogenesis of the disease. One of the most important factors governing the inflammatory process is cytokines. Changes in the response of the cytokines mentioned in systemic sclerosis, respiratory system involvement and related decrease in walking capacity, loss of muscle strength, weakening of hand functions, as well as weakening the psychological and social aspects of a person who is a biopsychosocial being. In addition to local physiotherapy applications such as paraffin applications, exercises for the face and hands, active stretching, exercise approaches such as exercises for aerobic endurance are also beneficial. However, there is no mention of a standardized exercise model, the quality of life of individuals with systemic sclerosis, which is a rare disease, activities of daily living, studies in which the social and psychological aspects of the individual are included in the treatment, and named and defined exercise methods are lacking in the literature. It is seen that studies are generally carried out with scales and functional tests.
Cognitive Exercise Therapy Approach, presents an example of an innovative biopsychosocial model with its own biopsychosocial scale, the basic exercise model of which is core stabilization exercises, including pain management, mood management and sexual information management. For individuals with systemic sclerosis, which is in the group of rare diseases, it is necessary to present the results of the intervention with objective evaluation methods to the literature. In this study, it is aimed to present an exercise model named for this disease group with objective results by examining the effects of Cognitive Exercise Therapy Approach (BETY) on vascularization, muscle strength, functionality, anti-inflammatory and biopsychosocial status in individuals with systemic sclerosis.
- Conditions
- Systemic Sclerosis
- Being tested
- Cognitive Exercise Therapy Approach (BETY)
- Keywords
- Systemic Sclerosis, Biopsychosocial model, BETY, Muscle strength, Functionality, Vascularization, Anti-inflammatory responses
- Medical subject headings
- Scleroderma, Systemic, Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Exercise Therapy Approach (BETY)Other
BETY, based on function-oriented core stabilization exercises, will be applied in patients with systemic sclerosis. This exercise model includes pain management strategies, dance therapy-authentic movement. Function-oriented core stabilization exercises have the feature of being made difficult against gravity according to the person's ability to do. Initial exercises start from the stage where the distal segment of the extremity is on the ground, called closed-kinetic. This level, which is quite easy, becomes more difficult following the success of the individual. It can be started from the mat level and progressed by modifying it with theraband and exercise ball. It is used at the beginning and end of dance therapy and authentic movement sessions. In the session, cognitive restructuring technique is used to break the vicious cycle of pain-emotional-spasm during exercise. This exercise model is the main rehabilitation approach of the Rheumatological Rehabilitation Unit.
| Study group | Role | What they receive |
|---|---|---|
| BETY Group | Active comparator | Since 2004, group exercise sessions have been organized as a routine form of treatment for individuals diagnosed with rheumatism in the Department of Physiotherapy and Rehabilitation of Hacettepe University. The first evaluation will be made if the individuals who come to the routine doctor's examination agree to participate in the study. According to being included in one of the two groups as those who decided to attend the BETY sessions that have been going on for 18 years and those who did not agree to attend the sessions; The individuals included in the BETY group (Group 1) will be evaluated on the day of the last exercise session after their participation in the 12-week exercise group. Receives: Other: Cognitive Exercise Therapy Approach (BETY) |
| Control Group | No intervention | Individuals (Group 2), who do not agree to participate in BETY sessions but agree to participate in evaluations with 12-week intervals, will be evaluated when they come for their routine check-ups at 12-week intervals, and recommendations given routinely. |
What is being measured
The primary outcome is the main question the study is designed to answer.
BETY-Biopsychosocial Questionnaire (BETY-BQ)
It is a 5-point Likert-type scale consisting of 30 questions developed with individuals with rheumatism. It is a practical scale that evaluates individuals in terms of fatigue and functionality, sleep, mood, sexuality, pain and sociability. Each question is scored as "0= never, 1=yes rarely, 2=yes sometimes, 3=yes often 4=yes always" and gives a total score over 30 items. A high score means a low biopsychosocial level. The total score is scored between 0-120
Measured: 3 Months
Secondary outcomes (10)
Modified Rodnan Skin Score (mRSS)
A method in which the skin firmness of the person is evaluated by holding the skin between two fingers and looking at the degree of stretching. 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 0-51
Measured: 3 Months
Quality of Life Scale Short Form-36 (SF-36)
SF-36 Quality of Life Scale; It is a 36-item, 11-question scale that allows general health screening with 8 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: 3 Months
Scleroderma Health Assessment Questionnaire (SHAQ)
Dressing and grooming, arising, eating, walking, hygiene, reach, grip and activities are evaluated with 20 items divided into eight areas. The answers given to each question range from "without any difficulty (0)", "with some difficulty (1)", "with much difficulty (2)" and "unable to do (3)". Afterwards, it is requested to show how Raynaud's phenomenon, digital ulcers, intestinal involvement, respiratory and overall disease severity affect the daily activity level on a 15 cm long section. The SHAQ-global score is formed by dividing the sum of the scores of these 8 parameters and 5 items by 13. High score indicates low functionality.
Measured: 3 Months
Modified Hand Mobility in Scleroderma (mHAMIS)
It is a method in which the hand functions of individuals are evaluated by a physiotherapist. It evaluates 4 different hand functions based on observation.
Measured: 3 Months
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: 3 Months
Six-minute walk test (6MWT)
In order to evaluate the aerobic capacity of individuals, they will be toured for 6 minutes at a distance of 30 meters. The average 6MWT is between 400 and 700 meters.
Measured: 3 Months
Evaluation of muscle strength
Muscle strength assessment of knee joint flexor and extensor muscle group will be made with Biodex System Pro3® (Biodex Corp, Shirley, NY, USA) device. Before each measurement, patients will be tested 3 times, and knee flexor and extensor maximal concentric isokinetic muscle strength will be measured at 180°/sec 10 repetitions and 60°/sec 5 repetitions angular speeds, with a 30 sec rest interval after each angular velocity.
Measured: 3 Months
Evaluation of vascular structure
Doppler ultrasonography technique is an ultrasonography method that evaluates the blood flow passing through the lumens of the vascular structures in the body. In this method, flow velocity and resistance measurements can be made in vascular structures by measuring the changing return frequencies of sound waves sent from ultrasound probes to the tissues due to the movement of blood cells flowing in the vessel. In the study, the vascular status of the arteries on the forearm and palmar face will be examined by Doppler ultrasonography.
Measured: 3 Months
Evaluation of anti-inflammatory effects
Examination of the cytokine profiles of the patients will be done before and after the treatment for Group 1, and for Group 2 at the initial and final evaluation. IL-6, IL-10, TNF-a and Irisin values, which are the cytokines that the literature focuses on in the pathophysiology of systemic sclerosis, will be checked by blood analysis with the same measurement units at Hacettepe University Central Laboratory.
Measured: 3 Months
Hospital Anxiety and Depression Scale (HADS)
It is a scale that evaluates anxiety and depression, which are psychological symptoms that can occur with diseases, with 14 items. Each question is scored between 0-3 points and a total score between 0 and 21 points can be obtained. A total score of 0-7 is considered normal, a score of 8-10 is considered borderline abnormal (borderline case), and a score of 11-21 is considered abnormal (case).
0-7 points are normal, 8-10 points are borderline abnormal (borderline case) and 11-21 points are abnormal (case) It is considered.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start2 Feb 2022
- Primary completion15 Mar 2022
- Study completion2 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic SclerosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Evaluation parameters will be applied to the participants twice with an interval of 12 weeks. The first evaluation will be made if the individuals who come to the routine doctor's examination agree to participate in the study. According to being included in one of the two groups as those who decided to attend the BETY sessions that have been going on for 18 years and those who did not agree to attend the sessions; The individuals included in the BETY group (Group 1) will be evaluated on the day of the last exercise session after their participation in the 12-week exercise group, the individuals who do not agree to participate in the BETY sessions but agree to participate in the evaluations at 12-week intervals (Group 2) will be evaluated when they come 12 weeks apart for their routine controls. For patients with systemic sclerosis, the recommendations given routinely in our unit will be made.
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
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
- NCT05453071
- Sponsor's protocol ID
- Go 19/191
- Status last verified
- Jul 2023
- First submitted
- 29 Jun 2022
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tufekci O, Unal E, Aktas BE, Tan AA, Hartuc Cevik I, Karabulut E, Pinar A, Korkusuz F, Onur MR, Kiraz S, Akdogan A. Do functionality, strength, vascularization, inflammatory and biopsychosocial status improve by biopsychosocial model-based exercise in SSc? Rheumatology (Oxford). 2025 Apr 1;64(4):1940-1948. doi: 10.1093/rheumatology/keae365.
PubMed 39018183
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Cognitive Exercise Therapy Approach on Vascularization, Muscle Strength, Functionality, Anti-Inflammatory and Biopsycosocial Status in Individuals With Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT05453071
- Acronym / sponsor ID
- Go 19/191
- Conditions
- Systemic Sclerosis
- Keywords
- Systemic Sclerosis, Biopsychosocial model, BETY, Muscle strength, Functionality, Vascularization, Anti-inflammatory responses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 2 Nov 2022 (actual)
- First posted
- 12 Jul 2022 (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.
The aim of this study is to investigate the effects of Cognitive Exercise Therapy Approach (BETY) on vascularization, muscle strength, functionality, anti-inflammatory and biopsychosocial status in individuals with systemic sclerosis and to present a named exercise model for this disease group with objective results.
Detailed description
Systemic sclerosis is an inflammatory and chronic autoimmune disease. Systemic sclerosis, which was first defined by Hippocrates as thickened skin, can also progress with skin involvement and fibrosis of internal organs. Although the exact pathogenesis of the disease is not understood, it is thought to occur as a result of interactions between factors affecting collagen synthesis, fibrosis, capillary (vasculopathy) changes and immunological mechanisms. The role of inflammation has an important place in the pathogenesis of the disease. One of the most important factors governing the inflammatory process is cytokines. Changes in the response of the cytokines mentioned in systemic sclerosis, respiratory system involvement and related decrease in walking capacity, loss of muscle strength, weakening of hand functions, as well as weakening the psychological and social aspects of a person who is a biopsychosocial being. In addition to local physiotherapy applications such as paraffin applications, exercises for the face and hands, active stretching, exercise approaches such as exercises for aerobic endurance are also beneficial. However, there is no mention of a standardized exercise model, the quality of life of individuals with systemic sclerosis, which is a rare disease, activities of daily living, studies in which the social and psychological aspects of the individual are included in the treatment, and named and defined exercise methods are lacking in the literature. It is seen that studies are generally carried out with scales and functional tests.
Cognitive Exercise Therapy Approach, presents an example of an innovative biopsychosocial model with its own biopsychosocial scale, the basic exercise model of which is core stabilization exercises, including pain management, mood management and sexual information management. For individuals with systemic sclerosis, which is in the group of rare diseases, it is necessary to present the results of the intervention with objective evaluation methods to the literature. In this study, it is aimed to present an exercise model named for this disease group with objective results by examining the effects of Cognitive Exercise Therapy Approach (BETY) on vascularization, muscle strength, functionality, anti-inflammatory and biopsychosocial status in individuals with systemic sclerosis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Evaluation parameters will be applied to the participants twice with an interval of 12 weeks. The first evaluation will be made if the individuals who come to the routine doctor's examination agree to participate in the study. According to being included in one of the two groups as those who decided to attend the BETY sessions that have been going on for 18 years and those who did not agree to attend the sessions; The individuals included in the BETY group (Group 1) will be evaluated on the day of the last exercise session after their participation in the 12-week exercise group, the individuals who do not agree to participate in the BETY sessions but agree to participate in the evaluations at 12-week intervals (Group 2) will be evaluated when they come 12 weeks apart for their routine controls. For patients with systemic sclerosis, the recommendations given routinely in our unit will be made.
| Arm | Type | Receives |
|---|---|---|
| BETY Group | Active comparator | Other: Cognitive Exercise Therapy Approach (BETY)Since 2004, group exercise sessions have been organized as a routine form of treatment for individuals diagnosed with rheumatism in the Department of Physiotherapy and Rehabilitation of Hacettepe University. The first evaluation will be made if the individuals who come to the routine doctor's examination agree to participate in the study. According to being included in one of the two groups as those who decided to attend the BETY sessions that have been going on for 18 years and those who did not agree to attend the sessions; The individuals included in the BETY group (Group 1) will be evaluated on the day of the last exercise session after their participation in the 12-week exercise group. |
| Control Group | No intervention | –Individuals (Group 2), who do not agree to participate in BETY sessions but agree to participate in evaluations with 12-week intervals, will be evaluated when they come for their routine check-ups at 12-week intervals, and recommendations given routinely. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having been diagnosed with Systemic Sclerosis
- Being between the ages of 18-65
- Regular attendance at the rheumatology outpatient clinic at Hacettepe University
- No medication change in the last 3 months
Key exclusion criteria (9 listed)
- Having a severe musculoskeletal disability Being diagnosed with pulmonary hypertension
- FVC value below 50%
- History of active infection
- Symptomatic cardiac involvement
- Having a psychiatric disorder
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 |
|---|---|---|
| Cognitive Exercise Therapy Approach (BETY)BETY, based on function-oriented core stabilization exercises, will be applied in patients with systemic sclerosis. This exercise model includes pain management strategies, dance therapy-authentic movement. Function-oriented core stabilization exercises have the feature of being made difficult against gravity according to the person's ability to do. Initial exercises start from the stage where the distal segment of the extremity is on the ground, called closed-kinetic. This level, which is quite easy, becomes more difficult following the success of the individual. It can be started from the mat level and progressed by modifying it with theraband and exercise ball. It is used at the beginning and end of dance therapy and authentic movement sessions. In the session, cognitive restructuring technique is used to break the vicious cycle of pain-emotional-spasm during exercise. This exercise model is the main rehabilitation approach of the Rheumatological Rehabilitation Unit. | Other | BETY Group |
Primary outcome
BETY-Biopsychosocial Questionnaire (BETY-BQ)
Time frame: 3 Months
It is a 5-point Likert-type scale consisting of 30 questions developed with individuals with rheumatism. It is a practical scale that evaluates individuals in terms of fatigue and functionality, sleep, mood, sexuality, pain and sociability. Each question is scored as "0= never, 1=yes rarely, 2=yes sometimes, 3=yes often 4=yes always" and gives a total score over 30 items. A high score means a low biopsychosocial level. The total score is scored between 0-120
10 secondary outcomes
Modified Rodnan Skin Score (mRSS)
Time frame: 3 Months
Quality of Life Scale Short Form-36 (SF-36)
Time frame: 3 Months
Scleroderma Health Assessment Questionnaire (SHAQ)
Time frame: 3 Months
Modified Hand Mobility in Scleroderma (mHAMIS)
Time frame: 3 Months
Duruoz Hand Index
Time frame: 3 Months
Six-minute walk test (6MWT)
Time frame: 3 Months
Evaluation of muscle strength
Time frame: 3 Months
Evaluation of vascular structure
Time frame: 3 Months
Evaluation of anti-inflammatory effects
Time frame: 3 Months
Hospital Anxiety and Depression Scale (HADS)
Time frame: 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Derived from this study: PubMed 39018183Tufekci O, Unal E, Aktas BE, Tan AA, Hartuc Cevik I, Karabulut E, Pinar A, Korkusuz F, Onur MR, Kiraz S, Akdogan A. Do functionality, strength, vascularization, inflammatory and biopsychosocial status improve by biopsychosocial model-based exercise in SSc? Rheumatology (Oxford). 2025 Apr 1;64(4):1940-1948. doi: 10.1093/rheumatology/keae365.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Exercise Therapy Approach (BETY) in people with Systemic Sclerosis, 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 10 Jul 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BETY-Biopsychosocial Questionnaire (BETY-BQ) (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05453071, which also lists 1 linked publication.
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 10 Jul 2023.