Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Scleroderma
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Mixed methods modelMasking: None (Open Label)Masking Description: The study is not blinded.Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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....

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).

Tracking Information

NCT #
NCT04491396
Collaborators
  • Richard Silver
  • Marvella Ford
  • Paul Nietert
  • Therese Killeen
Investigators
Not Provided