Yoga for Scleroderma

(GYYB Trial)

Overseen By Sundar Balasubramanian, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Psychiatric disorder, Physical limitations, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether gentle yoga and breathing exercises can help manage symptoms for people with scleroderma, a condition that hardens and tightens the skin. Participants will practice these exercises twice a day at home and record their experiences in a diary. The study will measure changes in symptoms and overall satisfaction over 12 weeks. This trial suits those with scleroderma who aren't already practicing yoga regularly and can perform exercises while seated. Participants will receive support from study coordinators and compensation for travel. As an unphased trial, this study offers a unique opportunity to explore non-drug interventions for symptom management.

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 prior data suggests that gentle yoga and breathing exercises are safe for scleroderma patients?

Research has shown that gentle yoga and breathing exercises are generally safe for people with scleroderma. One report described two women with scleroderma who practiced yoga without experiencing negative effects during or after the exercises, indicating good tolerance. Another study found that gentle yoga and breathing can alleviate symptoms like dry mouth by promoting relaxation. Overall, these findings suggest that gentle yoga and breathing exercises offer a safe way to manage symptoms in people with scleroderma. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about gentle yoga and yogic breathing for scleroderma because these approaches offer a non-pharmacological alternative to traditional treatments. While standard care typically involves medications to manage symptoms and inflammation, yoga and breathing exercises aim to enhance overall well-being and reduce stress, which can potentially alleviate symptoms. This holistic approach could provide a complementary option that empowers patients to actively participate in their own care, potentially improving quality of life without the side effects associated with medication.

What evidence suggests that gentle yoga and yogic breathing might be effective for scleroderma?

Research has shown that gentle yoga and breathing exercises can help manage symptoms in people with scleroderma. One study found that these practices might improve symptoms by helping the body relax. Some evidence suggests that yoga can reduce inflammation, pain, and stiffness while also enhancing quality of life. Early findings indicate that gentle exercise, like yoga, benefits both physical and mental health. Overall, yoga and breathing exercises appear promising as a supportive treatment for scleroderma symptoms. Participants in this trial will engage in a program of gentle yoga and yogic breathing to assess its impact on scleroderma symptoms. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Gentle Yoga and Yogic Breathing

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.

How Is the Trial Designed?

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+

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04491396

Yoga Adjunct for Scleroderma (GYYB) This is a pilot research study to determine the feasibility of gentle yoga and breathing exercises for symptom management in patients with scleroderma.

2. withpower.com withpower.com/trial/phase-scleroderma-diffuse-2020-2118b

Yoga for Scleroderma (GYYB Trial) This is a pilot research study to determine the feasibility of gentle yoga and breathing exercises for symptom management in patients with scleroderma.

3. researchgate.net researchgate.net/publication/378548955_An_Online_Program_of_Seated_Gentle_Yoga_Yogic_Breathing_Improves_Symptoms_in_Scleroderma_A_Quality_Improvement_Study

(PDF) An Online Program of Seated Gentle Yoga & Yogic ... Gentle yoga & yogic breathing improves salivation and other symptoms through parasympathetic dominance and may help scleroderma patients.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8642665/

Yoga therapy as an adjunct to conventional management ... The limited evidence from the current study indicates that Yoga may reduce inflammation, pain, stiffness, and symptoms and improve QoL. The ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8478716/

Exercise as a multi-modal disease-modifying medicine in ... The impact of yoga, singing [253], and gentle exercise positively impacts both physical and psychological outcomes [30,35,111–116,254]. Initiation ...

6. youtube.com youtube.com/watch?v=dXT_JQB-PXc

Importance of Meditation and Breathing with Scleroderma - Dr ... Balasubramanian shows that regulated breathing exercises can help stimulate saliva and can promote healing within the body and mind.