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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Nova Southeastern University
- Enrollment
- 40
- Locations
- 6
- Primary Endpoint
- Stress management for Individuals with Parkinson's Disease
Study Overview
Brief Summary
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.
Detailed Description
Protocol Summary
Introduction: Parkinson's Disease (PD) is a neuro-degenerative disease & movement disorder with no known cure. Symptoms include tremor & neuro-psychiatric issues. Stress significantly exacerbates symptoms of PD. This study aims to determine the feasibility and efficacy of an evidence-based stress reduction and resilience building breathwork intervention named SKY Breath and Meditation (SKY Breath) to improve the psycho-physiological wellbeing in a cohort of community dwelling individuals diagnosed with PD (iPD).
Methodology: This mixed methodology feasibility study will evaluate the tremor, gait, mental wellbeing of a cohort of patients from several organizations with iPD. Measures of motor and non-motor symptoms will be tested before and after the intervention. The standardized program will be modified according to the level of iPD disability and limitation. Data is stratified according to disability level. 20 iPD and 20 care partners will be consented for participation.
Active Learning Phase 1: A 10-12 hour active learning phase (4 day morning program) will be presented. The length of this phase will be determined upon iPD participant stamina. Participants will be given a home practice to complete with an audiotape and a handout as a supplement. When necessary, the SKY Breath practice can be broken up to accommodate a schedule. This will encourage as many individuals as possible to participate. A parallel course will be given to the care partners.
Phase 2:This includes daily personal home practice taking about 25 minutes, which can be done independently or online with instructor. There is also once weekly instructor guided session online lasting approximately 45 minutes. And one weekly session in-person, lasting 75 minutes. IPD Measures standardized measures of PD symptoms motor and non-motor symptoms and Quality of Life (QoL) care partners receive QoL, stress and resilience measured. Participants will be evaluated pre-intervention, post week 2 and 8.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Stress management for Individuals with Parkinson's Disease
Time Frame: Pre-intervention, and 2 weeks, 4 weeks, 8 weeks post intervention
Improving the feelings of pressure and overwhelm measured before and after intervention from self-reported stress scales. Individuals with Parkinson's Disease evaluated on: * Parkinson's Disease Anxiety Scale- Scoring 0-48. Higher score=greater anxiety. * Perceived Stress Scale (PSS) -Scores from 0-40; higher scores=higher perceived stress.
Stress management for Care Partners of Individuals with Parkinson's Disease
Time Frame: Pre-intervention, and 2 weeks, 4 weeks, 8 weeks post intervention
Improving the feelings of pressure and overwhelm measured before and after intervention from self-reported stress scales. Care partners evaluated on: * Parkinson's Disease Care Giver Burden Questionnaire (PDCG) -Scoring 0-20=little/no burden;21-40=mild/moderate burden;41-60=moderate/severe burden;61-88=severe burden. * Perceived Stress Scale (PSS) -Scoring 0-40; higher scores=higher perceived stress.
Psycho-social well-being management for Individuals with Parkinson's Disease
Time Frame: Pre-intervention, and 2 weeks, 4 weeks, 8 weeks post intervention
Improving the general perceived mental health and well-being of individuals measured from self-reported scales. Individuals with Parkinson's Disease evaluated on: * Positive and Negative Affect Scale (PANAS)- Scoring 10-50 both sets. Total positive score, higher score=more positive affect. Total negative score, a lower score= less negative affect. * Parkinson's Fatigue Scale-Scoring 0-36. Total score of less than 36=may not be suffering from fatigue. * Parkinson's Disease Quality of Life Scale (PDQ-39)-Scoring 0-260; 0=no disability; 260=total disability.
Psycho-social well-being management for Care Partners of Individuals with Parkinson's Disease
Time Frame: Pre-intervention, and 2 weeks, 4 weeks, 8 weeks post intervention
Improving the general perceived mental health and well-being of individuals measured from self-reported scales. Care partners evaluated on: * Positive and Negative Affect Scale (PANAS)- Scoring 10-50 for both sets. Total positive score, a higher score=more positive affect. Total negative score, a lower score= less negative affect. * Parkinson's Disease Care Giver Burden Questionnaire (PDCG) -Scoring 0-20=little/no burden;21-40=mild/moderate burden;41-60=moderate/severe burden;61-88=severe burden.
Parkinson's Disease Symptom management/Relief
Time Frame: Pre-intervention, and at 2 weeks, 4 weeks and 8 weeks post intervention
Improving the symptoms of gait, balance, energy levels in individuals with Parkinson's Disease as measured from * the Hoehne and Yahr Scale taken as part of The International Parkinson and Movement Disorder Society sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS). * Score range: 0-52, 10 and below is mild, 22 and above is severe. Part II: Motor experiences of daily living: 13 items. Score range: 0-52, 12 and below is mild, 30 and above is severe.
Secondary Outcomes
No secondary outcomes reported