Yoga Adjunct for Scleroderma

NCT04491396 | Completed

• 1 other identifier: 12771
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Scleroderma

Outcome Measures

Primary Outcomes (7)

• Quality of life determination: SHAQ-DI

  Scleroderma Health Assessment Questionnaire and Disability Index (SHAQ-DI)

  12 weeks

• Perceived Stress

  Perceived Stress Scale

  12 weeks

• Depression

  10-item Center for Epidemiologic Studies Depression Scale

  12 weeks

• Salivary biomarkers

  IL-1β, IL-8 , IL-6, and MCP-1, and cortisol

  Weeks 0 and 12

• Feasibility test

  enrollment data

  Week 12

• Adherence

  Practice diary

  12 weeks

• Acceptance

  Satisfaction using likert scale

  12 weeks

Study Arms (1)

GYYB

OTHER

This is a single-arm pre-post design.

Behavioral: Gentle Yoga and Yogic Breathing

Interventions

Gentle Yoga and Yogic Breathing BEHAVIORAL

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

GYYB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women fulfilling the 2013 ACR/EULAR Classification for Systemic Sclerosis
• Self-identified race/ethnicity as AA or NHW
• Undergoing treatment from any healthcare provider
• years of age or older
• Ability to perform the study exercises involving gentle movements sitting on a chair and regulated breathing
• Access to a working telephone
• Access to watch a video from a DVD or from a website or Youtube

You may not qualify if:

• Diagnosed with psychiatric or cognitive disorder that precludes provision of written informed consent
• Physical limitations making Yoga techniques detrimental
• Enrolled in any other Yoga related clinical trials
• Currently engaged in regular Yoga activity (once per week or more).

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Richard Silver: collaborator
• Marvella Ford: collaborator
• Paul Nietert: collaborator
• Therese Killeen: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The study is not blinded.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Research

Model Details: Mixed methods model

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 29, 2020
• Study Start: January 8, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

US (1)