Scleroderma, SystemicNCT06425653
Exercise With Scleroderma Functional Outcomes
A study testing Exercise Program in people with Scleroderma, Systemic and Scleroderma, Diffuse, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
The study aims to investigate the effects of an exercise program applied to patients with scleroderma on functional outcomes (hand and mouth functional results and quality of life). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Scleroderma, Systemic, Scleroderma, Diffuse, Scleroderma, Limited
- What is being tested?
- Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Feb 2021to 5 Dec 2021
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The inclusion criteria were being aged between 18 to 70 years, having no communication problems, being able to speak Turkish and agreeing to participate in the study.
Who cannot join
- . The exclusion criteria were not having the ability to regularly perform hand and mouth exercises, having undergone hand surgery in the last six months, having open wounds or contractures on the hand, having hand and mouth functional disorders due to reasons other than scleroderma, having no teeth, having all upper and lower teeth as dentures and being included in a rehabilitation program in the last three months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Exercise Program Applied to Patients With Scleroderma on Functional Outcomes: A Randomized Controlled Trial
The study aims to investigate the effects of an exercise program applied to patients with scleroderma on functional outcomes (hand and mouth functional results and quality of life).
Read the detailed description
Systemic sclerosis (scleroderma) is a significant, rare autoimmune connective tissue disease characterized by autoantibodies, fibrosis of the skin and internal organs, microvascular injury and vascular damage due to endothelial cell activation (Sepulveda et al., 2019; Rosendahl et al., 2022). The term "scleroderma" is derived from two Greek words "sklero" and "derma" meaning hard skin (Bielacka et al., 2017; Singh et al., 2019).
The global prevalence of scleroderma is estimated to be between 0.3 and 40 per 100,000 population (Alhendi et al., 2020; Benz et al., 2021; Sierakowska et al., 2019). The occurrence of systemic sclerosis in women is three to five times and in some literature up to eight times higher than in men. The disease incidence peaks between the ages of 30 and 65 (Sierakowska et al., 2019; Hughes et al., 2020; Alhendi et al., 2020).
Impairment of hand functions is one of the most significant disabilities in patients with scleroderma and is commonly observed (Gregory et al., 2019; Mugii et al., 2019). The skin of the hand thickens with manifestations including fingertip ulcers, swelling of the fingers, raynaud's phenomenon and subcutaneous calcium deposition (Abreu et al., 2023). Deformities such as loss of flexion in the metacarpophalangeal joints, loss of extension in the proximal and distal interphalangeal joints, loss of abduction, flexion of the thumb and wrist movement can occur, leading to contractures and severe impairment of hand functions (Bongi \& Rosso, 2016; Vannajak et al., 2014).
Besides hand function impairment, another significant issue in scleroderma is the fibrotic involvement of the connective tissue of the face and mouth. Patients tend to lose facial expression. Sclerosis of the skin around the lips and mouth area causes a reduction in mouth opening (microstomia) and width (microcheilia) in 43% to 80% of cases (Puzio et al., 2019; Uras et al., 2019).
Rehabilitation strategies which play a crucial role in the management of scleroderma, include psychoeducational interventions, exercise therapy, application of physical methods, assistive devices and orthoses; joint protection and energy conservation approaches, dietary interventions and comprehensive multidisciplinary team care programs (Schouffoer et al., 2011). Among these interventions daily hand exercises are specifically mentioned to improve hand movement and function, and also mouth and facial exercises positively affect mouth opening function (Gregory et al., 2019). Hand rehabilitation enhances hand movement, functionality and strength, as well as participation in daily life activities such as self-care, housework, work and recreational activities, thereby improving quality of life (Bongi \& Rosso, 2016). Exercises that stretch the mouth and increase mouth opening are reported to prevent the progression of microstomia and reduce limitations in mouth opening (Puzio et al., 2019; Yuen et al., 2012). Some approaches and techniques involving active exercises for managing microstomia are suggested, indicating success with the performance of mandibular movements (Puzio et al., 2019).
Programs that include hand and oral rehabilitation interventions are needed to prevent hand deformities and oral dysfunctions, ensure positive body perception, provide coping strategies and maintain quality of life (Schouffoer et al., 2011; Vannajak et al., 2014). However, individuals with a rare disease such as scleroderma face many challenges, including lack of knowledge about the disease, difficulties in accurate diagnosis and limited treatment and support options. Professional support services that are usually provided to individuals with more common diseases are not available for scleroderma patients (Delisle et al., 2019).
Scleroderma is a chronic disease that affects multiple systems and can present numerous symptoms and complications, impacting individuals physically, psychologically and socially. Therefore, the care of patients with scleroderma requires an interdisciplinary holistic health approach that encompasses both physical and emotional support. The rarity of scleroderma, the fact that many patients live far from physical therapy and rehabilitation clinics or the necessity of continuous participation in a program necessitates the implementation of nurse-led home programs (Murphy et al., 2018).
- Conditions
- Scleroderma, Systemic, Scleroderma, Diffuse, Scleroderma, Limited, Hand Rheumatism, Mouth Movement Impaired
- Being tested
- Exercise Program
- Keywords
- exercise, hand and mouth functional outcomes, nursing, scleroderma, quality of life
- Medical subject headings
- Scleroderma, Systemic, Scleroderma, Diffuse, Scleroderma, Limited, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ProgramOther
In the intervention group in addition to the standard protocol, an exercise program intervention was applied and after the initial interview the "Exercise Program DVD" was provided through mobile phone. All patients were evaluated 4 times: at baseline, at the 4th week (first visit), at the 8th week (second visit) and at the 12th week (final visit) after randomization
| Study group | Role | What they receive |
|---|---|---|
| Exercise Program | Experimental | In the control group the standard protocol was applied. The standard protocol included routine care and treatment practices conducted by the same physician at the same institution. In the intervention group in addition to the standard protocol, an exercise program intervention was applied and after the initial interview the "Exercise Program DVD" was provided through mobile phone. All patients were evaluated 4 times: at baseline, at the 4th week (first visit), at the 8th week (second visit) and at the 12th week (final visit) after randomization Receives: Other: Exercise Program |
| Standart Protocol | No intervention | The standard protocol included routine care and treatment practices conducted by the same physician at the same institution. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic and disease characteristics of the participants
Of the patients included in the study, 50.0% (22 patients) were in the intervention group and 50.0% (22 patients) were in the control group. 95.5% of the intervention group were women and 4.5% were men, with the control group also comprising 95.5% women and 4.5% men patients. The mean age of the all patients was 51.70 ± 11.11 years. 63.6% of patients in the intervention group and 59.1% of patients in the control group were diagnosed with diffuse cutaneous scleroderma. The mean duration of scleroderma diagnosis of all the patients was 9.54 ± 6.73 years for the intervention group and 9.4 ± 6.20 years for the control group. The majority in both groups (63.6% in the intervention group / 95.5% in the control group) were nonsmokers. Table 1 compares the demographic and disease characteristics of the groups. Groups were similar with regard to the demographic and disease characteristics.
Measured: After 12 weeks
Secondary outcomes (1)
Hand functional outcomes of the participants
Upon examining the final follow-up hand functional outcomes of the intervention and control group patients, it has been observed that there is a statistically significant difference between the groups in terms of the average total score of the Duruöz Hand Scale for all sub-dimensions including kitchen, dressing, cleaning, workplace and other activities, as well as the overall average total score (p<0.05)
Measured: After 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start5 Feb 2021
- Primary completion5 Feb 2021
- Study completion5 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Scleroderma, SystemicStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- In the control group the standard protocol was applied. The standard protocol included routine care and treatment practices conducted by the same physician at the same institution. In the intervention group in addition to the standard protocol, an exercise program intervention was applied and after the initial interview the "Exercise Program DVD" was provided through mobile phone. All patients were evaluated 4 times: at baseline, at the 4th week (first visit), at the 8th week (second visit) and at the 12th week (final visit) after randomization
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Gizem Özbudak, Trakya University
- Investigators
- Gizem Özbudak, PhD, Principal investigator, Trakya UniversitySerap Özer, PhD, Study chair, Ege UniversityFigen Yargucu Zihni, MD, Study chair, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425653
- Sponsor's protocol ID
- 20-9T/25
- Status last verified
- May 2024
- First submitted
- 10 May 2024
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sierra-Sepulveda A, Esquinca-Gonzalez A, Benavides-Suarez SA, Sordo-Lima DE, Caballero-Islas AE, Cabral-Castaneda AR, Rodriguez-Reyna TS. Systemic Sclerosis Pathogenesis and Emerging Therapies, beyond the Fibroblast. Biomed Res Int. 2019 Jan 23;2019:4569826. doi: 10.1155/2019/4569826. eCollection 2019.
PubMed 30809542Rosendahl AH, Schonborn K, Krieg T. Pathophysiology of systemic sclerosis (scleroderma). Kaohsiung J Med Sci. 2022 Mar;38(3):187-195. doi: 10.1002/kjm2.12505. Epub 2022 Mar 2.
PubMed 35234358Kowal-Bielecka O, Fransen J, Avouac J, Becker M, Kulak A, Allanore Y, Distler O, Clements P, Cutolo M, Czirjak L, Damjanov N, Del Galdo F, Denton CP, Distler JHW, Foeldvari I, Figelstone K, Frerix M, Furst DE, Guiducci S, Hunzelmann N, Khanna D, Matucci-Cerinic M, Herrick AL, van den Hoogen F, van Laar JM, Riemekasten G, Silver R, Smith V, Sulli A, Tarner I, Tyndall A, Welling J, Wigley F, Valentini G, Walker UA, Zulian F, Muller-Ladner U; EUSTAR Coauthors. Update of EULAR recommendations for the treatment of systemic sclerosis. Ann Rheum Dis. 2017 Aug;76(8):1327-1339. doi: 10.1136/annrheumdis-2016-209909. Epub 2016 Nov 9.
PubMed 27941129Singh D, Parihar AK, Patel S, Srivastava S, Diwan P, Singh MR. Scleroderma: An insight into causes, pathogenesis and treatment strategies. Pathophysiology. 2019 Jun;26(2):103-114. doi: 10.1016/j.pathophys.2019.05.003. Epub 2019 May 18.
PubMed 31130325Alhendi FJ, Werth VP, Sollecito TP, Stoopler ET. Systemic sclerosis: Update for oral health care providers. Spec Care Dentist. 2020 Sep;40(5):418-430. doi: 10.1111/scd.12492. Epub 2020 Jul 6.
PubMed 33448431Benz K, Baulig C, Knippschild S, Strietzel FP, Hunzelmann N, Jackowski J. Prevalence of Oral and Maxillofacial Disorders in Patients with Systemic Scleroderma-A Systematic Review. Int J Environ Res Public Health. 2021 May 14;18(10):5238. doi: 10.3390/ijerph18105238.
PubMed 34069099Sierakowska M, Doroszkiewicz H, Sierakowska J, Olesinska M, Grabowska-Jodkowska A, Brzosko M, Leszczynski P, Pawlak-Bus K, Batko B, Wiland P, Majdan M, Bykowska-Sochacka M, Romanowski W, Zon-Giebel A, Jeka S, Ndosi M. Factors associated with quality of life in systemic sclerosis: a cross-sectional study. Qual Life Res. 2019 Dec;28(12):3347-3354. doi: 10.1007/s11136-019-02284-9. Epub 2019 Sep 3.
PubMed 31482431Hughes M, Pauling JD, Armstrong-James L, Denton CP, Galdas P, Flurey C. Gender-related differences in systemic sclerosis. Autoimmun Rev. 2020 Apr;19(4):102494. doi: 10.1016/j.autrev.2020.102494. Epub 2020 Feb 13.
PubMed 32062031Gregory WJ, Wilkinson J, Herrick AL. A randomised controlled trial of wax baths as an additive therapy to hand exercises in patients with systemic sclerosis. Physiotherapy. 2019 Sep;105(3):370-377. doi: 10.1016/j.physio.2018.08.008. Epub 2018 Sep 5.
PubMed 30318128Mugii N, Matsushita T, Oohata S, Okita H, Yahata T, Someya F, Hasegawa M, Fujimoto M, Takehara K, Hamaguchi Y. Long-term follow-up of finger passive range of motion in Japanese systemic sclerosis patients treated with self-administered stretching. Mod Rheumatol. 2019 May;29(3):484-490. doi: 10.1080/14397595.2018.1466635. Epub 2018 May 15.
PubMed 29667474Marcatto de Abreu MF, Landim S, Yuamoto FY, Lins C, Magalhaes EP, Etchebehere M. Screening tool development for hand surgery referrals in systemic sclerosis. Clinics (Sao Paulo). 2023 Aug 17;78:100270. doi: 10.1016/j.clinsp.2023.100270. eCollection 2023.
PubMed 37597472Maddali-Bongi S, Del Rosso A. Systemic sclerosis: rehabilitation as a tool to cope with disability. Clin Exp Rheumatol. 2016 Sep-Oct;34 Suppl 100(5):162-169. Epub 2016 Jul 4.
PubMed 27384349Vannajak K, Boonprakob Y, Eungpinichpong W, Ungpansattawong S, Nanagara R. The short-term effect of gloving in combination with Traditional Thai Massage, heat, and stretching exercise to improve hand mobility in scleroderma patients. J Ayurveda Integr Med. 2014 Jan;5(1):50-5. doi: 10.4103/0975-9476.128859.
PubMed 24812476Puzio A, Przywara-Chowaniec B, Postek-Stefanska L, Mrowka-Kata K, Trzaska K. Systemic sclerosis and its oral health implications. Adv Clin Exp Med. 2019 Apr;28(4):547-554. doi: 10.17219/acem/76847.
PubMed 30079996Uras C, Mastroeni S, Tabolli S, Masini C, Pallotta S, Teofoli P, Rocco G, Mazzanti C, Abeni D. A comparison between two educational methods in the rehabilitation of the microstomia in systemic sclerosis: a randomized controlled trial. Clin Rehabil. 2019 Nov;33(11):1747-1756. doi: 10.1177/0269215519858395. Epub 2019 Jun 19.
PubMed 31216880
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise Program Applied to Patients With Scleroderma on Functional Outcomes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06425653
- Acronym / sponsor ID
- 20-9T/25
- Conditions
- Scleroderma, Systemic, Scleroderma, Diffuse, Scleroderma, Limited, Hand Rheumatism, Mouth Movement Impaired
- Keywords
- exercise, hand and mouth functional outcomes, nursing, scleroderma, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 5 Feb 2021 (actual)
- Study completion
- 5 Dec 2021 (actual)
- First posted
- 22 May 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.
The study aims to investigate the effects of an exercise program applied to patients with scleroderma on functional outcomes (hand and mouth functional results and quality of life).
Detailed description
Systemic sclerosis (scleroderma) is a significant, rare autoimmune connective tissue disease characterized by autoantibodies, fibrosis of the skin and internal organs, microvascular injury and vascular damage due to endothelial cell activation (Sepulveda et al., 2019; Rosendahl et al., 2022). The term "scleroderma" is derived from two Greek words "sklero" and "derma" meaning hard skin (Bielacka et al., 2017; Singh et al., 2019).
The global prevalence of scleroderma is estimated to be between 0.3 and 40 per 100,000 population (Alhendi et al., 2020; Benz et al., 2021; Sierakowska et al., 2019). The occurrence of systemic sclerosis in women is three to five times and in some literature up to eight times higher than in men. The disease incidence peaks between the ages of 30 and 65 (Sierakowska et al., 2019; Hughes et al., 2020; Alhendi et al., 2020).
Impairment of hand functions is one of the most significant disabilities in patients with scleroderma and is commonly observed (Gregory et al., 2019; Mugii et al., 2019). The skin of the hand thickens with manifestations including fingertip ulcers, swelling of the fingers, raynaud's phenomenon and subcutaneous calcium deposition (Abreu et al., 2023). Deformities such as loss of flexion in the metacarpophalangeal joints, loss of extension in the proximal and distal interphalangeal joints, loss of abduction, flexion of the thumb and wrist movement can occur, leading to contractures and severe impairment of hand functions (Bongi \& Rosso, 2016; Vannajak et al., 2014).
Besides hand function impairment, another significant issue in scleroderma is the fibrotic involvement of the connective tissue of the face and mouth. Patients tend to lose facial expression. Sclerosis of the skin around the lips and mouth area causes a reduction in mouth opening (microstomia) and width (microcheilia) in 43% to 80% of cases (Puzio et al., 2019; Uras et al., 2019).
Rehabilitation strategies which play a crucial role in the management of scleroderma, include psychoeducational interventions, exercise therapy, application of physical methods, assistive devices and orthoses; joint protection and energy conservation approaches, dietary interventions and comprehensive multidisciplinary team care programs (Schouffoer et al., 2011). Among these interventions daily hand exercises are specifically mentioned to improve hand movement and function, and also mouth and facial exercises positively affect mouth opening function (Gregory et al., 2019). Hand rehabilitation enhances hand movement, functionality and strength, as well as participation in daily life activities such as self-care, housework, work and recreational activities, thereby improving quality of life (Bongi \& Rosso, 2016). Exercises that stretch the mouth and increase mouth opening are reported to prevent the progression of microstomia and reduce limitations in mouth opening (Puzio et al., 2019; Yuen et al., 2012). Some approaches and techniques involving active exercises for managing microstomia are suggested, indicating success with the performance of mandibular movements (Puzio et al., 2019).
Programs that include hand and oral rehabilitation interventions are needed to prevent hand deformities and oral dysfunctions, ensure positive body perception, provide coping strategies and maintain quality of life (Schouffoer et al., 2011; Vannajak et al., 2014). However, individuals with a rare disease such as scleroderma face many challenges, including lack of knowledge about the disease, difficulties in accurate diagnosis and limited treatment and support options. Professional support services that are usually provided to individuals with more common diseases are not available for scleroderma patients (Delisle et al., 2019).
Scleroderma is a chronic disease that affects multiple systems and can present numerous symptoms and complications, impacting individuals physically, psychologically and socially. Therefore, the care of patients with scleroderma requires an interdisciplinary holistic health approach that encompasses both physical and emotional support. The rarity of scleroderma, the fact that many patients live far from physical therapy and rehabilitation clinics or the necessity of continuous participation in a program necessitates the implementation of nurse-led home programs (Murphy et al., 2018).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In the control group the standard protocol was applied. The standard protocol included routine care and treatment practices conducted by the same physician at the same institution. In the intervention group in addition to the standard protocol, an exercise program intervention was applied and after the initial interview the "Exercise Program DVD" was provided through mobile phone. All patients were evaluated 4 times: at baseline, at the 4th week (first visit), at the 8th week (second visit) and at the 12th week (final visit) after randomization
| Arm | Type | Receives |
|---|---|---|
| Exercise Program | Experimental | Other: Exercise ProgramIn the control group the standard protocol was applied. The standard protocol included routine care and treatment practices conducted by the same physician at the same institution. In the intervention group in addition to the standard protocol, an exercise program intervention was applied and after the initial interview the "Exercise Program DVD" was provided through mobile phone. All patients were evaluated 4 times: at baseline, at the 4th week (first visit), at the 8th week (second visit) and at the 12th week (final visit) after randomization |
| Standart Protocol | No intervention | –The standard protocol included routine care and treatment practices conducted by the same physician at the same institution. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The inclusion criteria were being aged between 18 to 70 years, having no communication problems, being able to speak Turkish and agreeing to participate in the study.
Key exclusion criteria (1 listed)
- . The exclusion criteria were not having the ability to regularly perform hand and mouth exercises, having undergone hand surgery in the last six months, having open wounds or contractures on the hand, having hand and mouth functional disorders due to reasons other than scleroderma, having no teeth, having all upper and lower teeth as dentures and being included in a rehabilitation program in the last three months.
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 |
|---|---|---|
| Exercise ProgramIn the intervention group in addition to the standard protocol, an exercise program intervention was applied and after the initial interview the "Exercise Program DVD" was provided through mobile phone. All patients were evaluated 4 times: at baseline, at the 4th week (first visit), at the 8th week (second visit) and at the 12th week (final visit) after randomization | Other | Exercise Program |
Primary outcome
Demographic and disease characteristics of the participants
Time frame: After 12 weeks
Of the patients included in the study, 50.0% (22 patients) were in the intervention group and 50.0% (22 patients) were in the control group. 95.5% of the intervention group were women and 4.5% were men, with the control group also comprising 95.5% women and 4.5% men patients. The mean age of the all patients was 51.70 ± 11.11 years. 63.6% of patients in the intervention group and 59.1% of patients in the control group were diagnosed with diffuse cutaneous scleroderma. The mean duration of scleroderma diagnosis of all the patients was 9.54 ± 6.73 years for the intervention group and 9.4 ± 6.20 years for the control group. The majority in both groups (63.6% in the intervention group / 95.5% in the control group) were nonsmokers. Table 1 compares the demographic and disease characteristics of the groups. Groups were similar with regard to the demographic and disease characteristics.
1 secondary outcome
Hand functional outcomes of the participants
Time frame: After 12 weeks
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 22 May 2024.
- Results publication: PubMed 30809542Sierra-Sepulveda A, Esquinca-Gonzalez A, Benavides-Suarez SA, Sordo-Lima DE, Caballero-Islas AE, Cabral-Castaneda AR, Rodriguez-Reyna TS. Systemic Sclerosis Pathogenesis and Emerging Therapies, beyond the Fibroblast. Biomed Res Int. 2019 Jan 23;2019:4569826. doi: 10.1155/2019/4569826. eCollection 2019.
- Results publication: PubMed 35234358Rosendahl AH, Schonborn K, Krieg T. Pathophysiology of systemic sclerosis (scleroderma). Kaohsiung J Med Sci. 2022 Mar;38(3):187-195. doi: 10.1002/kjm2.12505. Epub 2022 Mar 2.
- Results publication: PubMed 27941129Kowal-Bielecka O, Fransen J, Avouac J, Becker M, Kulak A, Allanore Y, Distler O, Clements P, Cutolo M, Czirjak L, Damjanov N, Del Galdo F, Denton CP, Distler JHW, Foeldvari I, Figelstone K, Frerix M, Furst DE, Guiducci S, Hunzelmann N, Khanna D, Matucci-Cerinic M, Herrick AL, van den Hoogen F, van Laar JM, Riemekasten G, Silver R, Smith V, Sulli A, Tarner I, Tyndall A, Welling J, Wigley F, Valentini G, Walker UA, Zulian F, Muller-Ladner U; EUSTAR Coauthors. Update of EULAR recommendations for the treatment of systemic sclerosis. Ann Rheum Dis. 2017 Aug;76(8):1327-1339. doi: 10.1136/annrheumdis-2016-209909. Epub 2016 Nov 9.
- Results publication: PubMed 31130325Singh D, Parihar AK, Patel S, Srivastava S, Diwan P, Singh MR. Scleroderma: An insight into causes, pathogenesis and treatment strategies. Pathophysiology. 2019 Jun;26(2):103-114. doi: 10.1016/j.pathophys.2019.05.003. Epub 2019 May 18.
- Results publication: PubMed 33448431Alhendi FJ, Werth VP, Sollecito TP, Stoopler ET. Systemic sclerosis: Update for oral health care providers. Spec Care Dentist. 2020 Sep;40(5):418-430. doi: 10.1111/scd.12492. Epub 2020 Jul 6.
- Results publication: PubMed 34069099Benz K, Baulig C, Knippschild S, Strietzel FP, Hunzelmann N, Jackowski J. Prevalence of Oral and Maxillofacial Disorders in Patients with Systemic Scleroderma-A Systematic Review. Int J Environ Res Public Health. 2021 May 14;18(10):5238. doi: 10.3390/ijerph18105238.
- Results publication: PubMed 31482431Sierakowska M, Doroszkiewicz H, Sierakowska J, Olesinska M, Grabowska-Jodkowska A, Brzosko M, Leszczynski P, Pawlak-Bus K, Batko B, Wiland P, Majdan M, Bykowska-Sochacka M, Romanowski W, Zon-Giebel A, Jeka S, Ndosi M. Factors associated with quality of life in systemic sclerosis: a cross-sectional study. Qual Life Res. 2019 Dec;28(12):3347-3354. doi: 10.1007/s11136-019-02284-9. Epub 2019 Sep 3.
- Results publication: PubMed 32062031Hughes M, Pauling JD, Armstrong-James L, Denton CP, Galdas P, Flurey C. Gender-related differences in systemic sclerosis. Autoimmun Rev. 2020 Apr;19(4):102494. doi: 10.1016/j.autrev.2020.102494. Epub 2020 Feb 13.
- Results publication: PubMed 30318128Gregory WJ, Wilkinson J, Herrick AL. A randomised controlled trial of wax baths as an additive therapy to hand exercises in patients with systemic sclerosis. Physiotherapy. 2019 Sep;105(3):370-377. doi: 10.1016/j.physio.2018.08.008. Epub 2018 Sep 5.
- Results publication: PubMed 29667474Mugii N, Matsushita T, Oohata S, Okita H, Yahata T, Someya F, Hasegawa M, Fujimoto M, Takehara K, Hamaguchi Y. Long-term follow-up of finger passive range of motion in Japanese systemic sclerosis patients treated with self-administered stretching. Mod Rheumatol. 2019 May;29(3):484-490. doi: 10.1080/14397595.2018.1466635. Epub 2018 May 15.
- Results publication: PubMed 37597472Marcatto de Abreu MF, Landim S, Yuamoto FY, Lins C, Magalhaes EP, Etchebehere M. Screening tool development for hand surgery referrals in systemic sclerosis. Clinics (Sao Paulo). 2023 Aug 17;78:100270. doi: 10.1016/j.clinsp.2023.100270. eCollection 2023.
- Results publication: PubMed 27384349Maddali-Bongi S, Del Rosso A. Systemic sclerosis: rehabilitation as a tool to cope with disability. Clin Exp Rheumatol. 2016 Sep-Oct;34 Suppl 100(5):162-169. Epub 2016 Jul 4.
- Individual participant dataSharing planned: No
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A Clinical Study on Systemic Sclerosis and the Validation of French-language Questionnaires Assessing Disability, Quality of Life, and Disease Status.
Scleroderma
RecruitingPhase 1/2
A Study to Test CRT-402 in Refractory Autoimmune Disease
Autoimmune Diseases, Systemic Lupus Erythematosus
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.
Gizem Özbudak, PhD principal investigator
Trakya University
Serap Özer, PhD study chair
Ege University
Figen Yargucu Zihni, MD study chair
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Program in people with Scleroderma, Systemic and Scleroderma, Diffuse, run by Trakya 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 1 inclusion and 1 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 22 May 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?
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?
Demographic and disease characteristics of the participants (time frame: After 12 weeks). 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 NCT06425653, which also lists 20 linked publications.
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 22 May 2024.