30 Participants Needed

Yoga for Scleroderma

(GYYB Trial)

SB
Overseen BySundar Balasubramanian, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medical University of South Carolina
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on adding yoga and breathing exercises to your routine, so you likely won't need to stop your medications.

What data supports the effectiveness of the treatment Gentle Yoga and Yogic Breathing for Scleroderma?

A case series involving two women with systemic sclerosis (a type of scleroderma) showed that practicing Yoga alongside conventional treatment helped reduce pain, stiffness, and inflammation, and improved their quality of life. This suggests that Yoga might be a helpful addition to standard care for scleroderma.12345

Is yoga safe for people with scleroderma?

In a case series involving two women with scleroderma who practiced yoga, no adverse events were reported during their participation or follow-up, suggesting that yoga may be safe for people with this condition.13567

How does yoga differ from other treatments for scleroderma?

Yoga is unique for scleroderma as it focuses on improving quality of life and reducing symptoms like pain and stiffness through physical and mental exercises, rather than directly targeting the disease itself. Unlike conventional treatments, yoga is used as an adjunct therapy, meaning it is added to standard care to enhance overall well-being without the use of medication.1891011

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.
See 4 more

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
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Treatment

Participants engage in gentle yoga and breathing exercises twice daily at home for 12 weeks, with weekly phone check-ins

12 weeks
1 visit (in-person), weekly phone calls

Follow-up

Participants return for a final study visit to perform yoga exercises, provide saliva samples, and complete surveys

1 week
1 visit (in-person)

Treatment Details

Interventions

  • Gentle Yoga and Yogic Breathing
Trial OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: GYYBExperimental Treatment1 Intervention
This is a single-arm pre-post design.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials
994
Recruited
7,408,000+

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+

References

Yoga therapy as an adjunct to conventional management of systemic sclerosis: A case series. [2021]
Daily occupations and well-being in women with limited cutaneous systemic sclerosis. [2019]
Complementary and alternative medicine use was associated with higher perceived physical and mental functioning in early systemic sclerosis. [2022]
Symptoms of disease and psychological adaptation in Brazilian scleroderma patients. [2013]
The Scleroderma Research Topics Survey for patients and health care professionals: A Scleroderma Patient-centered Intervention Network Project. [2022]
Factors associated with patient-reported likelihood of using online self-care interventions: a Scleroderma Patient-centered Intervention Network (SPIN) cohort study. [2023]
Effects of a Resilience-Building Energy Management Program on Fatigue and Other Symptoms in Systemic Sclerosis: A Randomized Controlled Trial. [2023]
Short-Term Pulmonary Rehabilitation for a Female Patient with Chronic Scleroderma under a Single-Case Research Design. [2020]
Can home rehabilitation impact impulse oscillometry and lung ultrasound findings in patients with scleroderma-associated interstitial lung disease? A pilot study. [2022]
Challenges and strategies for coping with scleroderma: implications for a scleroderma-specific self-management program. [2020]
Training and support needs of scleroderma support group facilitators: the North American Scleroderma Support Group Facilitators Survey. [2020]