An interventional study of Progressive Muscle Relaxation Exercise in Systemic Sclerosis (SSc), sponsored by University of Gaziantep. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by University of Gaziantep · Not applicable, Interventional, and Supportive care
This study aims to evaluate the effects of progressive muscle relaxation exercises on fatigue, dyspnea, and respiratory function in patients with systemic sclerosis. Participants will be assessed before and after the intervention.
Systemic sclerosis is a chronic autoimmune connective tissue disease that can affect multiple organs, including the respiratory system. Respiratory involvement may lead to symptoms such as dyspnea and fatigue and may adversely affect respiratory function and quality of life.
Progressive muscle relaxation exercise is a non-pharmacological relaxation technique that involves systematically tensing and relaxing different muscle groups. This technique may reduce physical and psychological tension and may contribute to the management of symptoms such as fatigue and dyspnea.
The purpose of this study is to evaluate the effect of progressive muscle relaxation exercises on fatigue, dyspnea, and respiratory function in patients with systemic sclerosis. Participants will undergo baseline assessments before the intervention. Progressive muscle relaxation exercises will then be administered, followed by post-intervention assessments to determine changes in fatigue, dyspnea, and respiratory function.
The findings of this study may provide evidence regarding the potential use of progressive muscle relaxation exercises as a supportive non-pharmacological intervention for symptom management in patients with systemic sclerosis.
610 studies on the registry are indexed under Scleroderma, Systemic; 218 are open to participants now.
This study's planned enrollment of 50 is above the median of 37 across 446 interventional studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →University of Gaziantep is the lead sponsor of 105 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 8, 2026. See what changed
Inclusion Criteria:Individuals who meet the study eligibility criteria will be included in the study. Eligible participants will be adults aged 18 years or older, diagnosed with systemic sclerosis, and have adequate physical and cognitive capacity to participate in the study.
Exclusion Criteria:Individuals who do not meet the inclusion criteria, who are unable to participate in the progressive muscle relaxation exercises due to their physical or cognitive condition, or who withdraw from the study voluntarily will be excluded from the study.
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Participants randomly assigned to this group will receive progressive muscle relaxation exercises in addition to standard care.
Behavioral: Progressive Muscle Relaxation Exercise
Participants randomly assigned to this group will receive standard care without progressive muscle relaxation exercises.
Participants in the intervention group will receive progressive muscle relaxation exercises according to the study protocol. The intervention will be administered in addition to standard care.
Fatigue severity measured by the FACIT-Fatigue Scale
Fatigue will be assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale. Changes in fatigue scores from baseline to post-intervention assessment will be evaluated between the intervention and control groups.
Time frame: Baseline and 4 weeks after the intervention
Dyspnea severity measured by the Dyspnea-12 (D-12) Scale
Dyspnea will be assessed using the Dyspnea-12 (D-12) Scale. Changes in dyspnea scores from baseline to post-intervention assessment will be evaluated between the intervention and control groups.
Time frame: Baseline and 4 weeks after the intervention
Respiratory function measured by forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC)
Respiratory function will be assessed using spirometry, including forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC). Changes in FEV1 and FVC from baseline to post-intervention assessment will be evaluated between the intervention and control groups.
Time frame: Baseline and 4 weeks after the intervention
Plan to share: No — Individual participant data will not be shared with other researchers. Data will be used only for the purposes of this study and will be handled in accordance with applicable ethical and data protection requirements.
Started Apr 2026 (actual). Primary completion is estimated for Nov 2026, 6 months after the start.
Of 94 non-industry interventional studies with no phase under Scleroderma, Systemic, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 38. This study's planned 6 months is below that.
Counting every sponsor, half of 100 studies reached it within 23 months; a quarter within 10 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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