Breathwork practice to improve well-being in Parkinson's patients and their care partners
A Feasibility and Efficacy Study of a Breathwork and Meditation Intervention (SKY Breath) on the Psychophysiological Well-Being of Individuals With Parkinson's Disease (iPD) and Their Care Partners
This study is testing if a special breathing and meditation practice can help improve the well-being of people with Parkinson's disease and their care partners.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Nova Southeastern University Academic / other |
| Locations | 3 sites (Coral Springs, Florida and 2 other locations) |
| Trial ID | NCT06581523 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the feasibility and efficacy of a breathwork and meditation intervention called Sudarshan Kriya Yoga (SKY Breath) for individuals with Parkinson's Disease (iPD) and their care partners. The study aims to determine if this intervention can be tailored to meet the unique needs of participants and whether it can reduce stress levels that exacerbate PD symptoms. Participants will undergo assessments of their mental and physical well-being before and after the intervention, which includes a structured active learning phase and home practice. The study will involve 20 individuals with iPD and 20 care partners, focusing on improving their overall quality of life.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with Parkinson's Disease in stages 1, 2, or 3, aged 18 to 75, along with their non-professional care partners.
Not a fit: Patients who are not in the specified stages of Parkinson's Disease or who are over 75 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the mental and physical well-being of individuals with Parkinson's Disease and their care partners.
How similar studies have performed: While the specific approach of SKY Breath is novel, similar breathwork and meditation interventions have shown promise in improving well-being in other patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Individuals with Parkinson's Disease (iPD) Inclusion Criteria: An individual with a formal diagnosis of iPD that: * are in stages 1, 2, or 3 * are at least 18 years of age * are no older than 75 years of age * can understand, read, write and speak English at a 5th grade level * that have access to zoom sessions online via laptop, ipad or other mobile device * are able to secure reliable transportation for themselves. Care Partner of the individuals with Parkinson's Disease (iPD) Inclusion Criteria: Individuals who: * are a care partner for an individual with Parkinson's Disease but are not paid professional givers of care * are at least 18 years of age or older * are able to secure reliable transportation for themselves and for the Individual with Parkinson's Disease * can understand, read, write and speak English at a 5th grade level * has access to zoom sessions online via laptop, iPad or other mobile device. Exclusion Criteria: Individuals with Parkinson's Disease (iPD): An individual who * has been diagnosed with Parkinson's Disease that is in stages 4 or 5 of the disease * is younger that age 18 or older than age 75 * has bipolar disorder * has seizure disorder * has schizophrenia or schizoaffective disorder * has active substance use * has uncontrolled hypertension * has cognitive impairment that prevents them from memorizing (remembering) the steps to complete the daily breath and meditation practice or completing the survey instruments, or has difficulty following sequential directions of the breathing practice * cannot understand, read, write and speak English at a 5th grade level * does not have access to zoom sessions online via laptop, iPad or other mobile device * can not secure transportation to the site for the training of the breath and meditation practice Care partner of the Individuals with Parkinson's Disease (iPD): Individuals who: * are paid professional givers of care * are under the age of 18 * an emancipated minor * have bipolar disorder * have seizure disorder * have schizophrenia or schizoaffective disorder * have active substance use * have uncontrolled hypertension * are not able to secure reliable transportation for themselves * cannot understand, read, write and speak English at a 5th grade level * does not have access to access to zoom sessions online via laptop, iPad or other mobile device.
Where this trial is running
Coral Springs, Florida and 2 other locations
- Raw Kickboxing and Fitness — Coral Springs, Florida, United States (Recruiting)
- David Posnack Jewish Community Center — Davie, Florida, United States (Not_yet_recruiting)
- Nova Southeastern University — Fort Lauderdale, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Venetia Bennett, BS, MS, PhD — Nova Southeastern University, Kiran Patel College of Osteopathic Medicine
- Study coordinator: Venetia Bennett, BS, MS, PhD
- Email: vb64@nova.edu
- Phone: 954-263-6535
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.