Parkinson's DiseaseSKYforiPDNCT06581523
Efficacy of a Breathwork Practice (SKY) on Well-Being of Individuals With Parkinson's Disease (iPD) and Care Partners
A study testing SKY Breath and Meditation in people with Parkinson's Disease, run by Nova Southeastern University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- SKY Breath and Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Oct 2024to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Raw Kickboxing and Fitness
Coral Springs, Florida, 33071
Mark Barker, BA, 954-575-6000
Allie Barker, 954-309-7814
- Not yet recruiting
David Posnack Jewish Community Center
Davie, Florida, 33328
Scott Ehrlich, MA, 954-420-6197 ext. 1215, sehrlich@dpjcc.org
Bonnie Rayman, MEd, 954-420-6197 ext. 1211, brayman@dpjcc.org
- Recruiting
Nova Southeastern University
Fort Lauderdale, Florida, 33328
Rania Massad, BA, DPT, 305-505-5465, rania@nova.edu
Venetia Bennett, BA, MS, PhD, 954-263-6535, vb64@nova.edu
About this study
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
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.
Read the detailed description
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
- Conditions
- Parkinson's Disease
- Being tested
- SKY Breath and Meditation
- Keywords
- Parkinson's Disease, Sudarshan Kriya Yoga, SKY Breath and Meditation, Care Partner of Individuals with Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKY Breath and MeditationBehavioural
Also called Sudarshan Kriya Yoga, SKY Breath
SKY Breath and Meditation is a unique breath-based technique that uses cyclical, rhythmic patterns of breath to bring the mind and body effortlessly into meditation. It has been empirically validated and holds distinct advantages over other forms of meditation.
| Study group | Role | What they receive |
|---|---|---|
| Individual with Parkinson's Disease | Experimental | 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. Receives: Behavioral: SKY Breath and Meditation |
| Care Partner of Individual with Parkinson's Disease | Experimental | 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. Receives: Behavioral: SKY Breath and Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress management for Individuals with Parkinson's Disease
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.
Measured: Pre-intervention, and 2 weeks, 4 weeks, 8 weeks post intervention
Stress management for Care Partners of Individuals with Parkinson's Disease
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.
Measured: Pre-intervention, and 2 weeks, 4 weeks, 8 weeks post intervention
Psycho-social well-being management for Individuals with Parkinson's Disease
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.
Measured: Pre-intervention, and 2 weeks, 4 weeks, 8 weeks post intervention
Psycho-social well-being management for Care Partners of Individuals with Parkinson's Disease
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.
Measured: Pre-intervention, and 2 weeks, 4 weeks, 8 weeks post intervention
Parkinson's Disease Symptom management/Relief
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.
Measured: Pre-intervention, and at 2 weeks, 4 weeks and 8 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start19 Oct 2024
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The SKY Breath and Meditation intervention will be for both the individuals with Parkinson's Disease and their care partners.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Venetia Bennett, BS, MS, PhD, Principal investigator, Nova Southeastern University, Kiran Patel College of Osteopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581523
- Sponsor's protocol ID
- 2024-434-NSU
- Acronym
- SKYforiPD
- Status last verified
- Feb 2026
- First submitted
- 29 Aug 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share at this point.
Publications
Seppala EM, Bradley C, Moeller J, Harouni L, Nandamudi D, Brackett MA. Promoting Mental Health and Psychological Thriving in University Students: A Randomized Controlled Trial of Three Well-Being Interventions. Front Psychiatry. 2020 Jul 15;11:590. doi: 10.3389/fpsyt.2020.00590. eCollection 2020.
PubMed 32760296Bayley PJ, Schulz-Heik RJ, Tang JS, Mathersul DC, Avery T, Wong M, Zeitzer JM, Rosen CS, Burn AS, Hernandez B, Lazzeroni LC, Seppala EM. Randomised clinical non-inferiority trial of breathing-based meditation and cognitive processing therapy for symptoms of post-traumatic stress disorder in military veterans. BMJ Open. 2022 Aug 25;12(8):e056609. doi: 10.1136/bmjopen-2021-056609.
PubMed 36008059Seppala EM, Nitschke JB, Tudorascu DL, Hayes A, Goldstein MR, Nguyen DT, Perlman D, Davidson RJ. Breathing-based meditation decreases posttraumatic stress disorder symptoms in U.S. military veterans: a randomized controlled longitudinal study. J Trauma Stress. 2014 Aug;27(4):397-405. doi: 10.1002/jts.21936.
PubMed 25158633Korkmaz A, Bernhardsen GP, Cirit B, Koprucu Suzer G, Kayan H, Bicmen H, Tahra M, Suner A, Lehto SM, Sag D, Saatcioglu F. Sudarshan Kriya Yoga Breathing and a Meditation Program for Burnout Among Physicians: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2353978. doi: 10.1001/jamanetworkopen.2023.53978.
PubMed 38294813Brown RP, Gerbarg PL. Sudarshan Kriya yogic breathing in the treatment of stress, anxiety, and depression: part I-neurophysiologic model. J Altern Complement Med. 2005 Feb;11(1):189-201. doi: 10.1089/acm.2005.11.189.
PubMed 15750381van Wamelen DJ, Wan YM, Ray Chaudhuri K, Jenner P. Stress and cortisol in Parkinson's disease. Int Rev Neurobiol. 2020;152:131-156. doi: 10.1016/bs.irn.2020.01.005. Epub 2020 Feb 19.
PubMed 32450994
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06581523
- Acronym / sponsor ID
- SKYforiPD / 2024-434-NSU
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease, Sudarshan Kriya Yoga, SKY Breath and Meditation, Care Partner of Individuals with Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Study start
- 19 Oct 2024 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The SKY Breath and Meditation intervention will be for both the individuals with Parkinson's Disease and their care partners.
| Arm | Type | Receives |
|---|---|---|
| Individual with Parkinson's Disease | Experimental | Behavioral: SKY Breath and MeditationThe 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 | Experimental | Behavioral: SKY Breath and MeditationThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SKY Breath and MeditationAlso: Sudarshan Kriya Yoga, SKY BreathSKY Breath and Meditation is a unique breath-based technique that uses cyclical, rhythmic patterns of breath to bring the mind and body effortlessly into meditation. It has been empirically validated and holds distinct advantages over other forms of meditation. | Behavioural | Care Partner of Individual with Parkinson's Disease, Individual with Parkinson's Disease |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Results publication: PubMed 32760296Seppala EM, Bradley C, Moeller J, Harouni L, Nandamudi D, Brackett MA. Promoting Mental Health and Psychological Thriving in University Students: A Randomized Controlled Trial of Three Well-Being Interventions. Front Psychiatry. 2020 Jul 15;11:590. doi: 10.3389/fpsyt.2020.00590. eCollection 2020.
- Results publication: PubMed 36008059Bayley PJ, Schulz-Heik RJ, Tang JS, Mathersul DC, Avery T, Wong M, Zeitzer JM, Rosen CS, Burn AS, Hernandez B, Lazzeroni LC, Seppala EM. Randomised clinical non-inferiority trial of breathing-based meditation and cognitive processing therapy for symptoms of post-traumatic stress disorder in military veterans. BMJ Open. 2022 Aug 25;12(8):e056609. doi: 10.1136/bmjopen-2021-056609.
- Results publication: PubMed 25158633Seppala EM, Nitschke JB, Tudorascu DL, Hayes A, Goldstein MR, Nguyen DT, Perlman D, Davidson RJ. Breathing-based meditation decreases posttraumatic stress disorder symptoms in U.S. military veterans: a randomized controlled longitudinal study. J Trauma Stress. 2014 Aug;27(4):397-405. doi: 10.1002/jts.21936.
- Results publication: PubMed 38294813Korkmaz A, Bernhardsen GP, Cirit B, Koprucu Suzer G, Kayan H, Bicmen H, Tahra M, Suner A, Lehto SM, Sag D, Saatcioglu F. Sudarshan Kriya Yoga Breathing and a Meditation Program for Burnout Among Physicians: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2353978. doi: 10.1001/jamanetworkopen.2023.53978.
- Results publication: PubMed 15750381Brown RP, Gerbarg PL. Sudarshan Kriya yogic breathing in the treatment of stress, anxiety, and depression: part I-neurophysiologic model. J Altern Complement Med. 2005 Feb;11(1):189-201. doi: 10.1089/acm.2005.11.189.
- Results publication: PubMed 32450994van Wamelen DJ, Wan YM, Ray Chaudhuri K, Jenner P. Stress and cortisol in Parkinson's disease. Int Rev Neurobiol. 2020;152:131-156. doi: 10.1016/bs.irn.2020.01.005. Epub 2020 Feb 19.
- Individual participant dataSharing planned: No. There is no plan to share at this point.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Venetia Bennett, BS, MS, PhD principal investigator
Nova Southeastern University, Kiran Patel College of Osteopathic Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SKY Breath and Meditation in people with Parkinson's Disease, run by Nova Southeastern University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Venetia Bennett, BS, MS, PhD (954-263-6535, vb64@nova.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress management for Individuals with Parkinson's Disease (time frame: Pre-intervention, and 2 weeks, 4 weeks, 8 weeks post intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06581523, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.