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

NCT06581523 | Recruiting

• 1 other identifier: 2024-434-NSU
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease; Sudarshan Kriya Yoga; SKY Breath and Meditation; Care Partner of Individuals with Parkinson's Disease

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Pre-intervention, and at 2 weeks, 4 weeks and 8 weeks post intervention

Study Arms (2)

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.

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.

Behavioral: SKY Breath and Meditation

Interventions

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.

Also known as: Sudarshan Kriya Yoga, SKY Breath

Care Partner of Individual with Parkinson's Disease; Individual with Parkinson's Disease

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Southeastern University: lead

Study Sites (3)

Raw Kickboxing and Fitness

Coral Springs, Florida, 33071, United States

RECRUITING

David Posnack Jewish Community Center

Davie, Florida, 33328, United States

NOT YET RECRUITING

Nova Southeastern University

Fort Lauderdale, Florida, 33328, United States

RECRUITING

Related Publications (6)

• 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.

  PMID: 32760296 RESULT

• Bayley 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.

  PMID: 36008059 RESULT

• Seppala 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.

  PMID: 25158633 RESULT

• Korkmaz 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.

  PMID: 38294813 RESULT

• Brown 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.

  PMID: 15750381 RESULT

• van 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.

  PMID: 32450994 RESULT

MeSH Terms

Conditions

Parkinson Disease

Interventions

Meditation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Venetia Bennett, BS, MS, PhD

  Nova Southeastern University, Kiran Patel College of Osteopathic Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Venetia Bennett, BS, MS, PhD

CONTACT

954-263-6535; vb64@nova.edu

Sharon C Siegel, DDS, MS, MBA

CONTACT

410-935-8857; scsiegel@nova.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The SKY Breath and Meditation intervention will be for both the individuals with Parkinson's Disease and their care partners.

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: September 3, 2024
• Study Start: October 19, 2024
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)