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Efficacy of a Breathwork Practice (SKY) on Well-Being of Individuals With Parkinson's Disease (iPD) and Care Partners

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 weeks
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether SKY breathing and meditation can lower stress and improve mental and physical well-being. It is for adults with stages 1–3 Parkinson’s disease and their unpaid care partners. Participants learn the practice over 4 days, practice daily for 4 weeks, and fill out surveys through week 8.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • People with Parkinson’s must have a formal diagnosis of stage 1, 2, or 3 disease.
  • People with Parkinson’s must be ages 18–75.
  • Care partners must be age 18 or older and must not be paid professional caregivers.
  • Everyone must understand, read, write, and speak English at a 5th-grade level.
  • Everyone must have a computer, tablet, or mobile device to join Zoom sessions online.
  • People with Parkinson’s must have reliable transportation for themselves.
  • Care partners must have reliable transportation for themselves and the person with Parkinson’s.

Who can't join

  • People with Parkinson’s cannot join if they have stage 4 or 5 disease or are outside ages 18–75.
  • Care partners cannot join if they are paid professional caregivers or under 18, including minors who are legally independent.
  • Anyone with bipolar disorder (a condition with major mood swings) or a seizure disorder cannot join.
  • Anyone with schizophrenia or schizoaffective disorder (conditions that can affect thoughts and sense of reality) cannot join.
  • Anyone with active substance use or uncontrolled high blood pressure cannot join.
  • People with Parkinson’s cannot join if thinking or memory problems keep them from remembering the practice, following its steps, or completing surveys.
  • Anyone who cannot use English at a 5th-grade level or cannot access Zoom online cannot join.
  • Anyone who cannot get reliable transportation to the training site cannot join.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (3)

FL