Clinical trial NCT04491396: Yoga Adjunct for Scleroderma
Official title: Assessing a Gentle Yoga Combined With Yoga Breathing (GYYB) Adjunct Intervention for Scleroderma Self-Management
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Scleroderma
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Richard Silver
name: Marvella Ford
name: Paul Nietert
name: Therese Killeen
First posted: 2020-07-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Mixed methods model
Primary purpose: TREATMENT

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.

Detailed description: 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).

This is a pilot study and will not test a hypothesis. There are no preliminary data for making assumptions regarding effect sizes and variability between Pre/Post measures in this intervention. The main goal of this pilot study is estimation.

Results will provide critical preliminary data for planning a larger study and information about differences (or lack thereof) by race/ethnicity. With N=30 patients overall (n=15 per race/ethnicity group), investigators will be able to obtain relatively precise estimates of completion rates (e.g., 95% confidence intervals extending ±14% for the entire group and extending ±20% for each race/ethnicity group). Assuming some drop-outs over the study (i.e., with n=26 completers), investigators will be able to estimate changes in expression of inflammatory biomarkers with adequate precision (e.g., 95% confidence intervals extending ±0.4 standard deviation units for the entire group and extending ±0.5 standard deviation units for each race/ethnicity group). Although hypothesis testing is secondary, note that this study will have 80% power to detect changes equivalent to 0.6 standard deviation units in the overall sample and 0.8 standard deviation units in each race/ethnicity group (NHW and AA).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Quality of life determination: SHAQ-DI
timeFrame: 12 weeks
measure: Perceived Stress
timeFrame: 12 weeks
measure: Depression
timeFrame: 12 weeks
measure: Salivary biomarkers
timeFrame: Weeks 0 and 12
measure: Feasibility test
timeFrame: Week 12
measure: Adherence
timeFrame: 12 weeks
measure: Acceptance
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: