Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06581523
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Efficacy of a Breathwork Practice SKY on Well-Being of Individuals With Parkinsons Disease iPD and Care Partners
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Feasibility and Efficacy Study of a Breathwork and Meditation Intervention SKY Breath on the Psychophysiological Well-Being of Individuals With Parkinsons Disease iPD and Their Care Partners
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SKYforiPD
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 Parkinsons 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 Parkinsons Disease and their care partners
Objective 2 Will the SKY Breath practice decrease stress levels a contributor to increasing PD symptoms for individuals with Parkinsonampampampamp39s 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 225 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
Objective 1 Can the SKY Breath practice be designed and implemented to specifically cater to the unique needs of individuals with Parkinsons Disease and their care partners
Objective 2 Will the SKY Breath practice decrease stress levels a contributor to increasing PD symptoms for individuals with Parkinsonampampampamp39s 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 225 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 Parkinsons 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 Parkinsons 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 2This 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 BoxingCoral 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
3 Background Aims
1 Purpose Statement This study aims to determine the feasibility and efficacy of an evidence-based stress reductionresilience 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
2 Objectives - Hypotheses
Objective 1 Alleviate Stress for Parkinsons 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 Parkinsons 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 The International Parkinson and Movement Disorder Society sponsored revision of the Unified Parkinsons 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
Parkinsons Anxiety Scale
Parkinsons Disease Care Giver Burden Questionnaire PDCG
Parkinsons Fatigue Scale
Parkinsons 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 225 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 Parkinsons 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
Parkinsons Disease Anxiety Scale
Parkinsons Fatigue Scale
Parkinsons Disease Quality of Life Scale PDQ-39
Perceived Stress Scale PSS
Care partners will be evaluated with
Positive and Negative Affect Scale PANAS
Parkinsons 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
2 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 partnersassuming 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 141st posttest
Week 20 Final posttest
Week 21 Focus group for iPD group and separate focus group for care partners
Weeks 22- 23 Data analysis
Introduction Parkinsons 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 Parkinsons 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 2This 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 BoxingCoral 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
3 Background Aims
1 Purpose Statement This study aims to determine the feasibility and efficacy of an evidence-based stress reductionresilience 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
2 Objectives - Hypotheses
Objective 1 Alleviate Stress for Parkinsons 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 Parkinsons 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 The International Parkinson and Movement Disorder Society sponsored revision of the Unified Parkinsons 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
Parkinsons Anxiety Scale
Parkinsons Disease Care Giver Burden Questionnaire PDCG
Parkinsons Fatigue Scale
Parkinsons 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 225 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 Parkinsons 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
Parkinsons Disease Anxiety Scale
Parkinsons Fatigue Scale
Parkinsons Disease Quality of Life Scale PDQ-39
Perceived Stress Scale PSS
Care partners will be evaluated with
Positive and Negative Affect Scale PANAS
Parkinsons 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
2 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 partnersassuming 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 141st posttest
Week 20 Final posttest
Week 21 Focus group for iPD group and separate focus group for care partners
Weeks 22- 23 Data analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None