Scleroderma, Systemic Clinical Trial
Official title:
The Effect of Exercise Program Applied to Patients With Scleroderma on Functional Outcomes: A Randomized Controlled Trial
Verified date | May 2024 |
Source | Trakya University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 44 |
Est. completion date | December 5, 2021 |
Est. primary completion date | February 5, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - . 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Gizem Özbudak | Edirne |
Lead Sponsor | Collaborator |
---|---|
Trakya University | The Scientific and Technological Research Council of Turkey |
Turkey,
Alhendi 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. — View Citation
Benz 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/ijer — View Citation
Delisle VC, Gumuchian ST, El-Baalbaki G, Korner A, Malcarne VL, Pelaez S, Carrier ME, Pepin M, Thombs BD; Scleroderma Support Group Project Advisory Team. Training and support needs of scleroderma support group facilitators: the North American Scleroderma — View Citation
Gregory 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. — View Citation
Hughes 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. — View Citation
Kowal-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-C — View Citation
Maddali-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. — View Citation
Marcatto 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. — View Citation
Mugii 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 Rhe — View Citation
Murphy SL, Barber MW, Homer K, Dodge C, Cutter GR, Khanna D. Occupational Therapy Treatment to Improve Upper Extremity Function in Individuals with Early Systemic Sclerosis: A Pilot Study. Arthritis Care Res (Hoboken). 2018 Nov;70(11):1653-1660. doi: 10.1 — View Citation
Puzio 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. — View Citation
Rosendahl 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. — View Citation
Schouffoer AA, Ninaber MK, Beaart-van de Voorde LJ, van der Giesen FJ, de Jong Z, Stolk J, Voskuyl AE, Scherptong RW, van Laar JM, Schuerwegh AJ, Huizinga TW, Vlieland TP. Randomized comparison of a multidisciplinary team care program with usual care in p — View Citation
Sierakowska 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 li — View Citation
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;2019:45698 — View Citation
Singh 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. — View Citation
Uras 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 N — View Citation
Vannajak 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 — View Citation
Yuen HK, Marlow NM, Reed SG, Mahoney S, Summerlin LM, Leite R, Slate E, Silver RM. Effect of orofacial exercises on oral aperture in adults with systemic sclerosis. Disabil Rehabil. 2012;34(1):84-9. doi: 10.3109/09638288.2011.587589. Epub 2011 Sep 27. — View Citation
* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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) | After 12 weeks | |
Other | 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) | After 12 weeks | |
Primary | 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. | After 12 weeks | |
Secondary | 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) | After 12 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03965780 -
The SPIN - Scleroderma Support Group Leader EDucation Program Trial (SPIN-SSLED)
|
N/A | |
Terminated |
NCT02558543 -
Subcutaneous Injection of Autologous Adipose Tissue-derived Stromal Vascular Fraction Into the Fingers of Patients With Systemic Sclerosis
|
Phase 2 | |
Withdrawn |
NCT01202045 -
Stress Echocardiography in the Detection of Pulmonary Arterial Hypertension in Systemic Sclerosis Patients
|
N/A | |
Terminated |
NCT01445821 -
Autologous Stem Cell Systemic Sclerosis Immune Suppression Trial
|
Phase 3 | |
Recruiting |
NCT05878717 -
A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease
|
Phase 3 | |
Recruiting |
NCT03559465 -
Profibrosing Role of B Lymphocytes in Patients With Systemic Sclerosis.
|
N/A | |
Not yet recruiting |
NCT03610217 -
Pragmatic Clinical Trials in Scleroderma
|
N/A | |
Completed |
NCT02655640 -
The Impact of Illness Perceptions on Health Related Outcomes in Patients With Lupus and Systemic Sclerosis
|
N/A | |
Completed |
NCT05622578 -
Phenotyping of Chronic Pain in Diffused Systemic Scleroderma
|
N/A | |
Recruiting |
NCT04804930 -
Trichoscopy and Systemic Scleroderma
|
||
Completed |
NCT03675581 -
A Study to Test Whether Nintedanib Influences the Components of Birth-control Pills in Women With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)
|
Phase 1 | |
Completed |
NCT03221257 -
Scleroderma Lung Study III - Combining Pirfenidone With Mycophenolate
|
Phase 2 | |
Recruiting |
NCT05559580 -
A Study in People With Systemic Sclerosis to Test Whether Avenciguat (BI 685509) Has an Effect on Lung Function and Other Systemic Sclerosis Symptoms
|
Phase 2 | |
Completed |
NCT00442611 -
A Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Diffuse Systemic Sclerosis (Scleroderma)
|
Phase 1/Phase 2 | |
Completed |
NCT00001330 -
Study of Silicone-Associated Connective Tissue Diseases
|
N/A | |
Completed |
NCT02597933 -
A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis
|
Phase 3 | |
Not yet recruiting |
NCT05821335 -
Leap Motion Based Gamefication Exercises in the Individuals With Systemic Sclerosis
|
N/A | |
Completed |
NCT00333437 -
Pulmonary Involvement in Scleroderma: A Clinical Study of the Safety and Efficacy of Mycophenolate Mofetil in Scleroderma Patients With Lung Involvement
|
N/A | |
Completed |
NCT00025818 -
Six Month Clinical Research Study for Patients With Moderate or Severe Dry Eye Syndrome
|
Phase 3 | |
Not yet recruiting |
NCT05351060 -
Novel Splinting Technique Using 3D Models
|
N/A |