Yoga for Scleroderma

(GYYB Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Medical University of South Carolina

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for men and women over 18 with any form of scleroderma, who are currently receiving treatment. Participants must be able to do gentle chair-based yoga movements and breathing exercises, have a working phone, and the ability to watch instructional videos online. It's not for those with psychiatric conditions that affect consent-giving, physical limitations preventing yoga practice, or anyone already doing regular yoga or in another yoga study.

Inclusion Criteria

Access to a working telephone

You are currently receiving treatment from a healthcare provider.

I have been diagnosed with systemic sclerosis according to the 2013 criteria.

Exclusion Criteria

You do yoga regularly, at least once a week.

You have physical limitations that may make it unsafe for you to do yoga.

Diagnosed with psychiatric or cognitive disorder that precludes provision of written informed consent

Treatment Details

Interventions

• Gentle Yoga and Yogic Breathing (Behavioral Intervention)

Trial Overview The study tests if gentle yoga and yogic breathing can help manage symptoms in scleroderma patients. It involves initial training at MUSC followed by twice-daily home practice using video guidance for 12 weeks. Progress is tracked through diaries and weekly calls from the coordinator.

Participant Groups

Group I: GYYB Experimental Treatment 1 Intervention

This is a single-arm pre-post design.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Dr. Erik Summers

Medical University of South Carolina

Chief Medical Officer

MD from University of Alabama at Birmingham

Dr. Patrick J. Cawley

Medical University of South Carolina

Chief Executive Officer

MD, MBA

Paul Nietert

Collaborator

Trials

1

Recruited

30+

Richard Silver

Collaborator

Trials

1

Recruited

30+

Marvella Ford

Collaborator

Trials

1

Recruited

30+

Therese Killeen

Collaborator

Trials

1

Recruited

30+