Protocol Summary
Introduction: Parkinson's Disease (PD) is a neuro-degenerative disease and movement
disorder with no known cure. Symptoms include tremor and 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 Sudarshan Kriya Yoga (SKY) Breath and Meditation (SKY Breath) to
improve the psycho-physiological wellbeing in a cohort of community dwelling individuals
diagnosed with Parkinson's Disease (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 Posnack 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.
Background / Aims
Purpose Statement: This study aims to determine the feasibility and efficacy of an
evidence-based stress reduction/resilience building breathwork intervention named
Sudarshan Kriya Yoga 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.
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)
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 The International
Parkinson and Movement Disorder Society sponsored revision of the Unified
Parkinson's Disease Rating Scale (MDS-UPDRS). All aspects of the SKY standardized
program will be modified according to the level of disability and limitation. The
other measures that will be used are:
Positive and Negative Affect Scale (PANAS)
Parkinson's Anxiety Scale
Parkinson's Disease Care Giver Burden Questionnaire (PDCG)
Parkinson's Fatigue Scale
Parkinson's Disease Quality of Life (PDQ-39)
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 Posnack 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 The
International Parkinson and Movement Disorder Society sponsored revision of the
Unified Parkinson's Disease Rating Scale (MDS-UPDRS) capturing the disease stage
with the modified Hoehn and Yahr Scale that is part of the MDS-UPDRS. This is in
addition to the:
Positive and Negative Affect Scale (PANAS)
Parkinson's Disease Anxiety Scale
Parkinson's Fatigue Scale
Parkinson's Disease Quality of Life Scale (PDQ-39)
Perceived Stress Scale (PSS)
Care partners will be evaluated with:
Positive and Negative Affect Scale (PANAS)
Parkinson's Disease Care Giver Burden Questionnaire (PDCG)
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).
Schedule of Events Weeks 1 - 2: Collaborative development of recruiting materials
and preparation of Institutional Review Board (IRB) application.
Week 3: Submission of IRB application, recruiting of Nova Southeastern University (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: Active recruiting, screening, and consenting of iPD and their care
partners(assuming IRB approval)
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 iPD group and separate focus group for care partners
Weeks 22- 23 Data analysis