An interventional study of Gentle Yoga and Yogic Breathing in Scleroderma, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment
This is a pilot research study to determine the feasibility of gentle yoga and breathing exercises for symptom management in patients with scleroderma. Participants will have a first study visit that includes completing demographic and quality-of-life surveys, learning the gentle yoga and breathing exercises, and providing two saliva samples before and after doing the exercises. After this visit, participants will do the gentle yoga and breathing exercises twice daily at home (morning and evening) by following a video hyperlink. Participants will make an entry in their Yoga Practice Diaries each time they practice at home. On the 12th Week, participants will return to MUSC for a final study visit that includes doing the gentle yoga and breathing exercises, providing saliva samples, and completing a satisfaction survey. There will be a total of 2 clinic visits (on Weeks 1 and 12). The study coordinator will telephone participants weekly during the 10 weeks that they do the gentle yoga and breathing exercises at home to answer questions and help solve any problems. Each visit will take about 2 hours for this research study, in addition to any routine clinical examinations. Each home yoga and breathing practice will take 1 hour. The total study duration is 12 Weeks (3 months). Participants will receive compensation for their travel in the form of prepaid Visa gift cards.
This pilot research project will:
The following specific aims will be examined in a Pre/Post design using a 12-week GYYB intervention as an adjunct self-management strategy along with usual care:
Specific Aim 1: Conduct a feasibility trial to assess changes in self-reported QoL in a 12-week adjunct GYYB program among scleroderma patients (N=30) receiving usual care. Outcomes will be assessed in the overall study population and stratified by race/ethnicity (NHW vs. AA).
Specific Aim 2: Assess changes in the expression of inflammatory biomarkers in a 12-week adjunct GYYB program in scleroderma patients receiving usual care. Outcomes will be assessed in the overall study population and stratified by race/ethnicity (NHW vs. AA).
This is a pilot study and will not test a hypothesis. There are no preliminary data for making assumptions regarding effect sizes and variability between Pre/Post measures in this intervention. The main goal of this pilot study is estimation.
Results will provide critical preliminary data for planning a larger study and information about differences (or lack thereof) by race/ethnicity. With N=30 patients overall (n=15 per race/ethnicity group), investigators will be able to obtain relatively precise estimates of completion rates (e.g., 95% confidence intervals extending ±14% for the entire group and extending ±20% for each race/ethnicity group). Assuming some drop-outs over the study (i.e., with n=26 completers), investigators will be able to estimate changes in expression of inflammatory biomarkers with adequate precision (e.g., 95% confidence intervals extending ±0.4 standard deviation units for the entire group and extending ±0.5 standard deviation units for each race/ethnicity group). Although hypothesis testing is secondary, note that this study will have 80% power to detect changes equivalent to 0.6 standard deviation units in the overall sample and 0.8 standard deviation units in each race/ethnicity group (NHW and AA).
528 studies on the registry are indexed under Scleroderma, Diffuse; 114 are open to participants now.
This study's enrollment of 30 is close to the median of 33 across 366 interventional studies indexed under Scleroderma, Diffuse.
Browse Scleroderma, Diffuse studies →Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.
Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This is a single-arm pre-post design.
Behavioral: Gentle Yoga and Yogic Breathing
Gentle Yoga (GY) postures can be done while seated on a chair (sometimes called "Chair Yoga") and have been shown to benefit people with symptoms associated with cancer.12 However, Yoga is under-studied in the area of scleroderma. While most traditional Yoga postures can be practiced by anyone, people with scleroderma often have limited physical movement and can be prone to injury. Gentle Yoga postures are physically much easier to do than traditional Yoga and, thus, may be more accessible for SSc patients with musculoskeletal and other impairments. Gentle Yoga postures that are done while seated on a chair also combine easily with YB, but little is known about the specific benefits of the GY+YB combination (GYYB). Further study is needed to determine whether GYYB may be an effective strategy for improving QoL in SSc patients. The Yoga intervention to be used in this study specifically involves GY done while seated in combination with YB.
Also known as: Chair Yoga and Pranayama
Quality of life determination: SHAQ-DI
Scleroderma Health Assessment Questionnaire and Disability Index (SHAQ-DI)
Time frame: 12 weeks
Perceived Stress
Perceived Stress Scale
Time frame: 12 weeks
Depression
10-item Center for Epidemiologic Studies Depression Scale
Time frame: 12 weeks
Salivary biomarkers
IL-1β, IL-8 , IL-6, and MCP-1, and cortisol
Time frame: Weeks 0 and 12
Feasibility test
enrollment data
Time frame: Week 12
Adherence
Practice diary
Time frame: 12 weeks
Acceptance
Satisfaction using likert scale
Time frame: 12 weeks
Plan to share: Undecided — Non-identifiable study results will be shared with the patient and scientific community.
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Medical University of South Carolina