Assessing a Gentle Yoga Combined With Yoga Breathing (GYYB) Adjunct Intervention for Scleroderma Self-Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Salivary biomarkers
研究概览
简要总结
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.
详细描述
This pilot research project will:
- Test the feasibility of a scleroderma self-management intervention that combines Gentle Yoga postures and Yoga Breathing (GYYB) as adjunctive treatment with standard care.
- Explore the effectiveness of GYYB for improving health-related quality-of-life (QoL) outcomes.
- Provide information about acceptance and adoption of a GYYB intervention by scleroderma patients of African ancestry (AA) and non-Hispanic white (NHW) scleroderma patients in the United States (US).
- Investigate, for the first time in scleroderma patients, the relationship between GYYB and inflammatory biomarker changes which may provide insight into biological changes associated with improved health-related QoL outcomes.
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The study is not blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •18 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
排除标准
- •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).
研究组 & 干预措施
GYYB
This is a single-arm pre-post design.
干预措施: Gentle Yoga and Yogic Breathing (Behavioral)
结局指标
主要结局
Salivary biomarkers
时间窗: Weeks 0 and 12
IL-1β, IL-8 , IL-6, and MCP-1, and cortisol
Quality of life determination: SHAQ-DI
时间窗: 12 weeks
Scleroderma Health Assessment Questionnaire and Disability Index (SHAQ-DI)
Depression
时间窗: 12 weeks
10-item Center for Epidemiologic Studies Depression Scale
Adherence
时间窗: 12 weeks
Practice diary
Perceived Stress
时间窗: 12 weeks
Perceived Stress Scale
Feasibility test
时间窗: Week 12
enrollment data
Acceptance
时间窗: 12 weeks
Satisfaction using likert scale
次要结局
未报告次要终点
研究者
Sundaravadivel Balasubramanian
Assistant Professor Research
Medical University of South Carolina