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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a breathwork and meditation technique, called SKY Breath, can improve the mental and physical well-being of people with Parkinson's Disease and their care partners. The researchers seek to find out if this practice can lower stress levels, which may worsen Parkinson's symptoms, and enhance life quality for both patients and caregivers. The trial suits those with Parkinson's in stages 1 to 3 and their non-professional care partners, who can access online sessions and have reliable transportation. Participants will learn and practice SKY Breath over several weeks and report their experiences through surveys. As an unphased trial, this study offers a unique opportunity to explore new ways to enhance well-being and manage stress.

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 prior data suggests that the SKY Breath practice is safe for individuals with Parkinson's Disease and their care partners?

Research has shown that SKY Breath and Meditation is generally safe and easy to manage. In a study with doctors, SKY significantly reduced stress, anxiety, and depression without causing serious side effects. This suggests it could be a gentle practice for people with Parkinson's Disease and their caregivers. Although specific data on side effects for this group is lacking, the absence of major issues in similar studies is encouraging. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SKY Breath and Meditation practice for Parkinson's Disease because it offers a non-pharmaceutical approach to managing symptoms. Unlike traditional treatments that often rely on medications like Levodopa or Dopamine agonists, this method utilizes controlled breathing techniques and meditation to potentially improve quality of life. It emphasizes stress reduction and mental well-being, which can be particularly beneficial for individuals with Parkinson's and their caregivers. By focusing on holistic wellness, this practice could complement existing treatments and offer a new avenue for symptom management without the side effects associated with medication.

What evidence suggests that the SKY Breath practice might be an effective treatment for Parkinson's Disease?

Research has shown that the SKY Breath and Meditation practice may help reduce stress, anxiety, and depression. In a study with 129 doctors, SKY significantly lowered these stress-related issues. Since stress can worsen Parkinson's symptoms, reducing it might improve the well-being of those with the disease. This trial will evaluate the effects of SKY Breath and Meditation on individuals with Parkinson's disease and their care partners. Analysis of gene activity suggests that SKY leads to positive changes in the body. This breathing practice could potentially help people with Parkinson's by reducing stress and improving mental and physical health. ^{1 2 4 6 7}

Who Is on the Research Team?

Venetia Bennett, BS, MS, PhD

Principal Investigator

Nova Southeastern University, Kiran Patel College of Osteopathic Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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 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]

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]

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]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06581523/efficacy-of-a-breathwork-practice-sky-on-well-being-of-individuals-with-parkinsons-disease-ipd-and-care-partners?dt_type=updated&id=117&slug=parkinsons-disease

Efficacy of a Breathwork Practice (SKY) on Well-Being ... Stress significantly exacerbates symptoms of PD. This study aims to determine the feasibility and efficacy of an evidence-based stress reduction ...

2. clinconnect.io clinconnect.io/trials/NCT06581523

Efficacy of a Breathwork Practice (SKY) on Well-Being of This clinical trial is exploring whether a breathwork and meditation program called SKY Breath can improve the mental and physical well-being of people living ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2949834125000078

Transcriptome profiling after Sudarshan Kriya Yoga and its ... In this study, we looked at the global transcriptome after SKY program as well as its practice in novices in a longitudinal study.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10831575/

Sudarshan Kriya Yoga Breathing and a Meditation ... This randomized clinical trial of 129 practicing physicians found that SKY significantly reduced stress, anxiety, and depression.

5. news-medical.net news-medical.net/news/20240205/Does-Sudarshan-Kriya-Yoga-(SKY)-practice-reduce-stress-and-increase-well-being-in-practicing-physicians.aspx

Does Sudarshan Kriya Yoga (SKY) practice reduce stress ... A group of researchers evaluated the efficacy of Sudarshan Kriya Yoga (SKY) in reducing psychological distress and enhancing wellness among physicians at risk ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8275425/

The Effects of Yoga on Patients with Parkinson's Disease In addition, 8 trials (80%) reported the blinding of outcome assessment, and 7 trials (70%) provided complete data for the outcomes.

7. researchgate.net researchgate.net/publication/365688937_Breathing-based_meditation_Sudarshan_Kriya_Yoga_increases_sense_of_coherence_No-cost_stress_prevention

Breathing-based meditation (Sudarshan Kriya Yoga ... Results and Conclusion Experience with the SKY breathing technique showed a statistically significant (p<0.05) increase of the sense of ...