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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNova Southeastern University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • SKY Breath and Meditation

    Behavioral

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Individual with Parkinson's DiseaseExperimental treatment 1 intervention
Group B: Care Partner of Individual with Parkinson's DiseaseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Pre-intervention, and 2 weeks, 4 weeks, 8 weeks post intervention
2

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.

Time frame
Pre-intervention, and 2 weeks, 4 weeks, 8 weeks post intervention
3

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.

Time frame
Pre-intervention, and 2 weeks, 4 weeks, 8 weeks post intervention
4

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.

Time frame
Pre-intervention, and 2 weeks, 4 weeks, 8 weeks post intervention

Secondary outcomes

Other outcomes

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