Breathwork Practice for Parkinson's Disease

(SKYforiPD Trial)

Recruiting at 2 trial locations

Overseen By Venetia Bennett, BA, MS, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Southeastern University

Disqualifiers: Bipolar, Seizure, Schizophrenia, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

40 Participants Needed

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators or your healthcare provider for guidance.

What data supports the effectiveness of the treatment SKY Breath and Meditation for Parkinson's Disease?

Research shows that mindfulness meditation, which is similar to SKY Breath and Meditation, can help improve emotional stability and reduce depressive symptoms in people with Parkinson's Disease. Additionally, yoga, which shares elements with SKY practices, has been shown to improve motor function and balance in individuals with Parkinson's Disease. ^{1 2 3 4 5}

Is breathwork practice safe for people with Parkinson's Disease?

Research on yoga and meditation practices, similar to breathwork, shows they are generally safe for people with Parkinson's Disease, with no reported adverse events in studies. ^{1 2 3 6 7}

How is the SKY Breath and Meditation treatment different from other treatments for Parkinson's disease?

SKY Breath and Meditation is unique because it combines specific breathing techniques and meditation to promote relaxation and emotional stability, which can help manage symptoms like stress and depression in Parkinson's disease. Unlike traditional drug treatments, it focuses on mind-body practices to improve overall well-being and resilience. ^{1 3 8 9 10}

Research Team

Venetia Bennett, BS, MS, PhD

Principal Investigator

Nova Southeastern University, Kiran Patel College of Osteopathic Medicine

Eligibility Criteria

This trial is for individuals with Parkinson's Disease in stages 1, 2, or 3 and under the age of 75, as well as their care partners. Participants must be willing to learn and practice SKY Breath meditation daily for four weeks and complete several surveys.

Inclusion Criteria

I have been diagnosed with early or mid-stage Parkinson's disease, am under 76, and can use Zoom.

I am a volunteer caregiver, over 18, with reliable transport and can use Zoom.

Exclusion Criteria

I am a care partner, over 18, can get to places on my own, and can use Zoom on a device.

I cannot participate due to advanced Parkinson's, severe cognitive issues, or lack of English or online access.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Active Learning Phase

Participants learn the SKY Breath and Meditation practice over 4 days, 2.25 hours each morning

1 week

4 visits (in-person)

Home Practice and Booster Sessions

Daily home practice with weekly online and in-person guided sessions

8 weeks

8 visits (in-person), 8 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• SKY Breath and Meditation

Trial Overview The study tests if SKY Breathwork and Meditation can improve mental and physical well-being in people with Parkinson's Disease (stages 1-3) and their caregivers. It involves learning the technique over four days then practicing it daily while tracking progress through surveys.

Participant Groups

Group I: Individual with Parkinson's Disease Experimental Treatment 1 Intervention

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.

Group II: Care Partner of Individual with Parkinson's Disease Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Nova Southeastern University

Lead Sponsor

Trials

103

Recruited

12,000+

Findings from Research

In a study involving 68 patients with mild-to-moderate Parkinson's disease, mindfulness meditation significantly improved depressive symptoms compared to stretching and resistance training, with a large effect size at week 8.

Mindfulness meditation also helped maintain emotional stability at week 20, while both interventions showed similar benefits on cognitive performance, suggesting mindfulness could be a valuable addition to rehabilitation for Parkinson's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized clinical trial of mindfulness meditation versus exercise in Parkinson's disease during social unrest. Kwok, JYY., Choi, EPH., Wong, JYH., et al.[2023]

An 8-week yoga intervention for individuals with Parkinson's Disease (PD) significantly improved motor function, postural stability, and functional gait, while also reducing fall risk among participants (n=15).

In contrast, the wait-list control group (n=12) showed improvements in postural stability but did not experience a reduction in fall risk, highlighting the specific benefits of the yoga intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional Improvements in Parkinson's Disease Following a Randomized Trial of Yoga. Van Puymbroeck, M., Walter, AA., Hawkins, BL., et al.[2020]

In a study involving 33 patients with mild to moderate Parkinson's disease, the yoga meditation program (YoMed) showed significant improvements in balance and joint kinesthesia compared to a traditional proprioceptive training program, indicating its effectiveness.

Both exercise programs were safe, with no adverse events reported, suggesting that mind-body techniques like YoMed could be beneficial for enhancing movement control and body awareness in individuals with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga Meditation Enhances Proprioception and Balance in Individuals Diagnosed With Parkinson's Disease. Cherup, NP., Strand, KL., Lucchi, L., et al.[2021]

A 9-week mindfulness-based stress reduction (MBSR) course significantly improved health-related quality of life for people with Parkinson's Disease (PwP), as indicated by a reduction in their PDQ-39 scores.

Care partners (CPs) also benefited from the MBSR course, showing increased mindful awareness, although their caregiver burden (measured by the ZBI) did not significantly change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness based stress reduction in people with Parkinson's disease and their care partners. Shah-Zamora, D., Allen, AM., Rardin, L., et al.[2021]

The MY-OT for PD program did not show significant changes in health-related quality of life (HRQoL) scores based on the Parkinson's Disease Questionnaire-8 (PDQ-8) among 17 participants over the study period.

Despite the lack of statistical improvement in HRQoL scores, participants reported perceived enhancements in mobility and daily activities, suggesting that qualitative benefits may exist and warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health-related quality of life changes after the merging yoga and occupational therapy for Parkinson's disease program: A mixed-methods study. Swink, LA., Fruhauf, CA., Atler, KE., et al.[2020]

The MY-OT for PD program, which combines yoga and occupational therapy, led to a reduction in self-reported falls from 10 during the control period to 6 during the intervention period among 17 participants over 8 weeks.

Participants showed significant improvements in balance and fall risk management, indicating that this program may effectively enhance safety and mobility for individuals with Parkinson's Disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Merging Yoga and Occupational Therapy for Parkinson's Disease: A Feasibility and Pilot Program. Swink, LA., Fling, BW., Sharp, JL., et al.[2021]

Complementary and alternative medicine (CAM) therapies, such as Tai Chi, yoga, and acupuncture, show some evidence of benefits for nonmotor symptoms (NMS) in Parkinson's disease, particularly in areas like sleep, cognition, and depression, although the studies often involve small sample sizes and lack standardization.

Exercise therapies, including occupational and physical therapy, have demonstrated potential benefits for NMS like depression and anxiety in Parkinson's patients, but the sustainability of these improvements remains uncertain due to short follow-up durations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complementary and Alternative Medicine and Exercise in Nonmotor Symptoms of Parkinson's Disease. Subramanian, I.[2022]

A study involving 66 patients with Parkinson's disease showed that Autogenic Training (AT) combined with Physiotherapy (PT) significantly improved motor performance compared to PT alone, with improvements of 51.78% in the AT group versus 35.24% in the control group after 8 weeks.

The benefits of AT persisted even at the 12-week follow-up, indicating that AT is an effective adjunct therapy for enhancing motor skills in Parkinson's disease patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of autogenic training in improving motor performances in Parkinson's disease. Ajimsha, MS., Majeed, NA., Chinnavan, E., et al.[2022]

Relaxation guided imagery (RGI) significantly reduced tremor in all 20 patients with Parkinson's disease, with a dramatic decrease from an average of 270.38 movements per minute to 35.57 movements per minute (P < 0.0001).

The effects of RGI lasted beyond the session, with tremor activity remaining significantly lower than baseline for up to 30 minutes after the intervention, and patients reported improvements lasting an average of 6.8 hours.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parkinson's disease tremor is diminished with relaxation guided imagery. Schlesinger, I., Benyakov, O., Erikh, I., et al.[2022]

An online mindfulness-based cognitive therapy (MBCT) intervention was found to be feasible and well-received, with a high completion rate among participants (27 out of 28) and positive satisfaction feedback.

Participants with Parkinson's disease showed significant reductions in anxiety and depressive symptoms, as measured by the GAD-7 and PHQ-9 scales, indicating that MBCT may effectively improve mental health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online Mindfulness-Based Cognitive Therapy for People with Parkinson's Disease and Their Caregivers: a Pilot Study. Seritan, AL., Iosif, AM., Prakash, P., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

A randomized clinical trial of mindfulness meditation versus exercise in Parkinson's disease during social unrest. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Functional Improvements in Parkinson's Disease Following a Randomized Trial of Yoga. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Yoga Meditation Enhances Proprioception and Balance in Individuals Diagnosed With Parkinson's Disease. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Mindfulness based stress reduction in people with Parkinson's disease and their care partners. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Health-related quality of life changes after the merging yoga and occupational therapy for Parkinson's disease program: A mixed-methods study. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Merging Yoga and Occupational Therapy for Parkinson's Disease: A Feasibility and Pilot Program. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Complementary and Alternative Medicine and Exercise in Nonmotor Symptoms of Parkinson's Disease. [2022]

8. Scotland pubmed.ncbi.nlm.nih.gov

Effectiveness of autogenic training in improving motor performances in Parkinson's disease. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Parkinson's disease tremor is diminished with relaxation guided imagery. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Online Mindfulness-Based Cognitive Therapy for People with Parkinson's Disease and Their Caregivers: a Pilot Study. [2022]