- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04491396
Yoga Adjunct for Scleroderma (GYYB)
Assessing a Gentle Yoga Combined With Yoga Breathing (GYYB) Adjunct Intervention for Scleroderma Self-Management
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: GYYB
This is a single-arm pre-post design.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life determination: SHAQ-DI
Time Frame: 12 weeks
|
Scleroderma Health Assessment Questionnaire and Disability Index (SHAQ-DI)
|
12 weeks
|
Perceived Stress
Time Frame: 12 weeks
|
Perceived Stress Scale
|
12 weeks
|
Depression
Time Frame: 12 weeks
|
10-item Center for Epidemiologic Studies Depression Scale
|
12 weeks
|
Salivary biomarkers
Time Frame: Weeks 0 and 12
|
IL-1β, IL-8 , IL-6, and MCP-1, and cortisol
|
Weeks 0 and 12
|
Feasibility test
Time Frame: Week 12
|
enrollment data
|
Week 12
|
Adherence
Time Frame: 12 weeks
|
Practice diary
|
12 weeks
|
Acceptance
Time Frame: 12 weeks
|
Satisfaction using likert scale
|
12 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12771
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Scleroderma
-
University of Texas Southwestern Medical CenterRecruitingScleroderma, Localized | Morphea | Frontal Linear Scleroderma en Coup de Sabre | Scleroderma, Circumscribed | Scleroderma, LinearUnited States
-
Northwestern UniversityCompletedSYSTEMIC SCLERODERMAUnited States
-
Gilead SciencesCompletedDiffuse Scleroderma | Limited SclerodermaAustralia
-
Mastelli S.r.lSintesi Research SrlTerminatedScleroderma DiseaseItaly
-
Lawson Health Research InstituteNovartis PharmaceuticalsTerminated
-
BiocadRecruitingSystemic SclerodermaRussian Federation
-
Rennes University HospitalCompleted
-
Castle Creek Biosciences, LLC.TerminatedScleroderma, Localized | Morphea | SclerodermaUnited States
-
Assistance Publique - Hôpitaux de ParisActelionCompleted
-
University Hospital, LilleRecruiting
Clinical Trials on Gentle Yoga and Yogic Breathing
-
Medical University of South CarolinaNational Institute of Nursing Research (NINR); National Institutes of Health...CompletedAging | Fatigue Syndrome, Chronic | Pain, ChronicUnited States
-
University of Alabama at BirminghamRecruitingAmyotrophic Lateral SclerosisUnited States
-
Spaulding Rehabilitation HospitalEnrolling by invitationSpinal Cord Injuries | Slow BreathingUnited States
-
Wake Forest University Health SciencesCompleted
-
Beth Israel Deaconess Medical CenterBrigham and Women's HospitalCompletedStress | Stress, Psychological | Sleep | Stress Physiology | Slow BreathingUnited States
-
Memorial Sloan Kettering Cancer CenterThe City College of New YorkCompleted
-
Massachusetts General HospitalUniversity of Toronto; Yoga Science FoundationCompletedStress | Negative Thoughts | Mild DepressionUnited States
-
Hospital Israelita Albert EinsteinRecruitingImpact of Yoga and Gentle Massage Practices on Symptom Management in Patients Undergoing HSCT (Yoga)Bone Marrow Transplantation | Hematopoietic Stem Cell TransplantationBrazil
-
Medical University of South CarolinaNational Institutes of Health (NIH)CompletedCancer | Neurodegenerative Diseases | Alzheimer DiseaseUnited States
-
Health Ricerca e Sviluppo S.R.L.Swami Vivekananda Yoga Anusandhana Samsthana, Bangaluru , India; Yoga Experience... and other collaboratorsUnknownCoronavirus Infection | Cytokine Storm | Mental DisorderItaly