An interventional study of Exercise Program in Scleroderma, Systemic, Scleroderma, Diffuse and Scleroderma, Limited, sponsored by Trakya University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-22.
Sponsored by Trakya University · Not applicable, Interventional, and Supportive care
Among 26 studies in Scleroderma, Diffuse with a site in Turkey — 9 open to participants now, 13 under way, 2 of them phase 3. Scleroderma, Diffuse · Turkey.
Among the 26 studies in Scleroderma, Diffuse with a site in Turkey, this one is the 10th largest by enrollment of the 17 interventional ones that give a count, is one of 4 that started in 2021, is one of 14 with no phase, and was the 14th registered.
310 studies on the registry are indexed under Scleroderma, Diffuse; 76 are open to participants now.
Browse Scleroderma, Diffuse studies →9 of the 26 studies in Scleroderma, Diffuse with a site in Turkey are open now. Recruiting first, the newest first:
University of Gaziantep · Sites in Turkey
Ages 18–65
Hacettepe University · Sites in Turkey
Ages 7+
Hacettepe University · Sites in Turkey
Ages 18+
Hacettepe University · Sites in Turkey
Ages 7+
Hacettepe University · Sites in Turkey
Ages 7+
A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →
Of the 55 Scleroderma, Diffuse studies recruiting now, 28 (51%) set no upper age limit and 20 (36%) stop at 75 or younger; 10 take children under 18; 10 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
26 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 4 started in 2021.
This study's enrollment of 44 is above the median of 38 across 227 interventional studies indexed under Scleroderma, Diffuse.
Median enrollment 46 across the 17 interventional studies, 50 across the 9 observational. Of the 10 that completed or were terminated, 0 (0%) have results posted.
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3 of 26 have an industry lead sponsor. The 10 most frequent:
Trakya University is the lead sponsor of 155 studies on the registry; 15 are open to participants now.
Trakya University has 1 study filed under Scleroderma, Diffuse — fewer than ten, so there is no comparison to draw.
5 of the studies in Scleroderma, Diffuse with a site in Turkey that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05925803Phase 3AstraZenecaDetermine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY) | 2027-01-06 |
| NCT06470048Novartis PharmaceuticalsA Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis | 2027-07-30 |
| NCT07183072Hacettepe UniversityPatients Diagnosed With Scleroderma: Physical Performance and Functionality | 2027-08 |
| NCT07182981Hacettepe UniversityPatients Diagnosed With Scleroderma and Their Chewing and Swallowing Performance | 2027-08 |
| NCT07182968Hacettepe UniversityCultural Adaptation, Validity, and Reliability of the Turkish Version of The PASTUL Questionnaire | 2027-08 |
Among the 26 studies in Scleroderma, Diffuse with a site in Turkey, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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).
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).
310 studies on the registry are indexed under Scleroderma, Diffuse; 76 are open to participants now.
This study's enrollment of 44 is above the median of 38 across 227 interventional studies indexed under Scleroderma, Diffuse.
Browse Scleroderma, Diffuse studies →Trakya University is the lead sponsor of 155 studies on the registry; 15 are open to participants now.
Compared within Scleroderma, Diffuse, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Scleroderma, Systemic. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Other: Exercise Program
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
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.
Time frame: After 12 weeks
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)
Time frame: After 12 weeks
Oral functional results of the participants
The mouth opening measurements at the final follow-up of the intervention and control group patients included in the study are compared in Table 3. A statistically significant difference was found between the final follow-up mouth opening measurement values of the groups (p\<0.05)
Time frame: After 12 weeks
Quality of life results of the participants
The final follow-up scores of the World Health Organization Quality of Life (WHOQOL) Scale averages for the patients in the intervention and control groups who participated in the study were compared. When all subdomains of the scale were evaluated, it was determined that there was a statistically significant difference between the final follow-up total score averages for the physical, psychological, social and environmental domains of the patients in both the intervention and control groups (p\<0.05)
Time frame: After 12 weeks
Plan to share: No
Ran from Feb 2021 to primary completion in Feb 2021, 0 months.
Of 51 non-industry interventional studies with no phase under Scleroderma, Diffuse, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 27. This study's 0 months is below that.
Counting every sponsor, half of 53 studies reached it within 16 months; a quarter within 4 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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