Efficacy of a Breathwork Practice (SKY) on Well-Being of Individuals With Parkinson's Disease (iPD) and Care Partners
- Conditions
- Parkinson's Disease
- Interventions
- Behavioral: SKY Breath and Meditation
- Registration Number
- NCT06581523
- Lead Sponsor
- Nova Southeastern University
- 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.
Recruiting will be done at a Gym teaching Rock Steady Boxing/Coral Springs, Cleveland Clinic and at the David Posner JCC as well as through the NSU Clinics (Flyers will be placed so that existing patients from the Department of Physical Therapy at NSU can inquire and be recruited). Results: Data will be analyzed using repeated measure ANOVA, with post hoc analysis of interactions between outcomes. Qualitative data will be scored for themes.
3. Background / Aims
1. Purpose Statement: This study aims to determine the feasibility and efficacy of an evidence-based stress reduction/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) and their care partners.
2. Objectives +/- Hypotheses:
Objective 1: Alleviate Stress for Parkinson's Disease (PD) Patients and Care partners Implement a SKY breath intervention to actively minimize stress levels in both PD patients and their care partners, contributing to an improved overall well-being and quality of life.
Objective 2: Develop Targeted Programs for PD Patients Design and implement effective and tailored programs specifically catering to the unique needs of PD patients and their care partners. Ensuring a comprehensive, cost effective, self-empowering treatment protocol that will contribute to improving the overall well-being and quality of life of the patients.
Objective 3: Relieve Burden on Care partners Introduce interventions and support mechanisms to alleviate the emotional and physical burden experienced by care partners of PD patients, promoting their resilience and well-being.
Objective 4: Alleviate Strain on the Healthcare System Implement strategies that reduce the strain on the healthcare system by enhancing the self-management capabilities of PD patients and their care partners, leading to potentially fewer hospital visits and resource utilization.
Objective 5: Establish a Compassionate and Comprehensive Model for PD Care Develop and propose a model for PD care that prioritizes compassion and comprehensiveness, serving as a potential blueprint for future healthcare practices in Parkinson's Disease adjunctive management.
Study Design (including Basic Timeline)
1. Methodology This mixed methodology feasibility study will evaluate the tremor, balance mental wellbeing of a cohort of patients from several organizations that have a group of PD patients. The study will consent and enrolls 20 iPD and 20 care partners. The iPD will have their disease stage evaluated using the Hoehn and Yahr scale.
Both the iPD and their care partners will be evaluated pre and post intervention on measures of anxiety and depression to include the Perceived Stress Scale (PSS). Measures of psycho-social wellbeing will also be measured. The research will also evaluate specific measures of function of for the iPD using the MDS-UPDURS Scale. All aspects of the standardized program will be modified according to the level of disability and limitation. The other measures that will be used are:
* PANAS (Positive and Negative Affect Scale)
* Parkinson's Anxiety Scale
* Parkinson's Disease Carer Questionnaire (PDQ- Carer)
* Parkinsons Fatigue Scale
* PDQ-39 (Parkinson's Disease Quality of Life)
The data will be stratified according to their level of disability and physical limitation.
After the pre-testing evaluation is done prior to the SKY Breath Intervention being taught to the iPD and their care partners at one of potentially three sites (RAW Kickboxing GYM, David Posner Jewish Community Center, DPJCC), Cleveland Clinic).
There are two phases to the SKY Breath intervention include 1). Phase 1: The Active Learning Phase and 2). Phase 2: The Booster and reinforcement sessions.
Active Learning Phase:
A 10-12 hour active learning phase (4 day morning program 2.25 hours each day) will be presented. The length of the active learning phase that is presented will be determined depending on the stamina of the participants. The PD patients will be given a home practice to complete with an audiotape. A handout will be given to the participants 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 and twice weekly instructor guided group sessions. One weekly session will be online, lasting approximately 45 minutes. The second weekly session will be in-person, lasting approximately 75 minutes.
The validated measures will be the standardized measures of PD symptoms MDS-UPDURS capturing the disease stage with the modified Hoehn and Yahr. Scale. This is in addition to the
* PANAS (Positive and Negative Affect Scale)
* Parkinson's Anxiety Scale
* Parkinsons Fatigue Scale
* PDQ-39 (Parkinson's Disease Quality of Life). Perceived Stress Scale (PSS)
Care partners will be evaluated with:
* PANAS (Positive and Negative Affect Scale)
* Parkinson's Disease Carer Questionnaire (PDQ- Carer)
* Perceived Stress Scale (PSS)
The PD individuals will be evaluated prior to learning the SKY Breath Practice and then 1 week, 4 weeks and 8 weeks post-intervention. The participants will need to practice 6 days a week that will be lead by a qualified instructor. The practice will be lead once a week on-line and once a week in person. (One practice will be done in the early morning by Zoom and one will be done on a weekend day in the afternoon).
2. Schedule of Events Weeks 1 - 2: collaborative development of recruiting materials and preparation of IRB application.
Week 3: submission of IRB application, recruiting of NSU students as Research Assistants and assistant coordinators
Weeks 4-6: training of NSU students for screening and administration of the test instruments.
Weeks 6- 11: (assuming IRB approval) active recruiting, screening, and consenting of pPD and their care partners
Weeks 10 - 11: baseline data collection (while to be conducted online)
Week 11: phase 1 of SKY breath meditation intervention (3 to 4 of 2 ½- 3 hours each sessions on consecutive mornings in person)
Week 12 - 19: once weekly in person group SKY booster session lasting 75 to 90 minutes, plus one online group SKY practice lasting 60 minutes.
Week 14:1st posttest
Week 20: final posttest
Week 21: focus group for pPD group and separate focus group for care partners
Weeks 22- 23 data analysis
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Individual with Parkinson's Disease SKY Breath and Meditation The intervention is the Sudarshan Kriya Yoga or SKY Breath and Meditation Practice. This will be taught over a 10-12 hour period, 2.25 hours for 4 early mornings. The participants will practice 6 days a week (a 35-45 minute practice)for a total of 8 weeks. Care Partner of Individual with Parkinson's Disease SKY Breath and Meditation The intervention is the Sudarshan Kriya Yoga or SKY Breath and Meditation Practice. This will be taught over a 10-12 hour period, 2.25 hours for 4 early mornings. The participants will practice 6 days a week (a 35-45 minute practice)for a total of 8 weeks.
- Primary Outcome Measures
Name Time Method Stress management for Individuals with Parkinson's Disease 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 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 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 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 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 Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Raw Kickboxing and Fitness
🇺🇸Coral Springs, Florida, United States
David Posnack Jewish Community Center
🇺🇸Davie, Florida, United States
Nova Southeastern University
🇺🇸Fort Lauderdale, Florida, United States