NCT06581523 · Nova Southeastern University
Efficacy of a Breathwork Practice (SKY) on Well-Being of Individuals With Parkinson's Disease (iPD) and Care Partners
(SKYforiPD)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
SKY Breath and Meditation
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Coral Springs, Florida
- Davie, Florida
- Fort Lauderdale, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2026 · Source of record for eligibility and locations