RECRUITING

Efficacy of a Breathwork Practice (SKY) on Well-Being of Individuals With Parkinson's Disease (iPD) and Care Partners

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this feasibility study and clinical trial is to learn if an evidenced-based breathwork and meditation intervention (SKY Breath) will improve the mental and physical well-being of individuals with Parkinson's Disease (iPD) in stages 1, 2, and 3, under the age of 75 and their care partners. The main questions it aims to answer are: * Objective 1: Can the SKY Breath practice be designed and implemented to specifically cater to the unique needs of individuals with Parkinson's Disease and their care partners. * Objective 2: Will the SKY Breath practice decrease stress levels (a contributor to increasing PD symptoms) for individuals with Parkinson\'s Disease (iPD) and their care partners as measured through self-reported surveys to improve overall well-being and quality of life. * Objective 3: Will the SKY Breath practice in part alleviate the emotional stress and physical burden experienced by care partners of PD patients, promoting their resilience and well-being. Participants will be asked to learn the SKY Breath and Meditation practice over the course of 4 days (2.25 hours each morning), practice SKY every day for 4 weeks and keep a log of time spent doing SKY. The participants will complete a series of surveys before learning the practice and then after at weeks 1, 4 and 8. The series of surveys will take about 20 minutes.

Official Title

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

Quick Facts

Study Start:2024-10-19
Study Completion:2025-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06581523

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * has been diagnosed with Parkinson's Disease that is in stages 4 or 5 of the disease
  2. * is younger that age 18 or older than age 75
  3. * has bipolar disorder
  4. * has seizure disorder
  5. * has schizophrenia or schizoaffective disorder
  6. * has active substance use
  7. * has uncontrolled hypertension
  8. * 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
  9. * cannot understand, read, write and speak English at a 5th grade level
  10. * does not have access to zoom sessions online via laptop, iPad or other mobile device
  11. * can not secure transportation to the site for the training of the breath and meditation practice
  12. * are paid professional givers of care
  13. * are under the age of 18
  14. * an emancipated minor
  15. * have bipolar disorder
  16. * have seizure disorder
  17. * have schizophrenia or schizoaffective disorder
  18. * have active substance use
  19. * have uncontrolled hypertension
  20. * are not able to secure reliable transportation for themselves
  21. * cannot understand, read, write and speak English at a 5th grade level
  22. * does not have access to access to zoom sessions online via laptop, iPad or other mobile device.

Contacts and Locations

Study Contact

Venetia Bennett, BS, MS, PhD
CONTACT
954-263-6535
vb64@nova.edu
Sharon C Siegel, DDS, MS, MBA
CONTACT
410-935-8857
scsiegel@nova.edu

Principal Investigator

Venetia Bennett, BS, MS, PhD
PRINCIPAL_INVESTIGATOR
Nova Southeastern University, Kiran Patel College of Osteopathic Medicine

Study Locations (Sites)

Raw Kickboxing and Fitness
Coral Springs, Florida, 33071
United States
David Posnack Jewish Community Center
Davie, Florida, 33328
United States
Nova Southeastern University
Fort Lauderdale, Florida, 33328
United States

Collaborators and Investigators

Sponsor: Nova Southeastern University

  • Venetia Bennett, BS, MS, PhD, PRINCIPAL_INVESTIGATOR, Nova Southeastern University, Kiran Patel College of Osteopathic Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-19
Study Completion Date2025-04

Study Record Updates

Study Start Date2024-10-19
Study Completion Date2025-04

Terms related to this study

Keywords Provided by Researchers

  • Parkinson's Disease
  • Sudarshan Kriya Yoga
  • SKY Breath and Meditation
  • Care Partner of Individuals with Parkinson's Disease

Additional Relevant MeSH Terms

  • Parkinson's Disease