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Yoga for Mental Health in Parkinson's Disease
N/A
Recruiting
Led By Balachundar Subramaniam, MD, MPH
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Interested in attending the Breath, Sound, and Meditation Webinar
Physically and mentally able to participate in the study procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for phase 1 analysis: baseline to week 12. for phase 2 analysis: baseline to week 18.
Awards & highlights
Study Summary
This trial is testing an intervention to see if it improves neuropsychological and somatic outcomes, with the goal of understanding how compliant people are with the treatment.
Who is the study for?
This trial is for adults over 18 in the US with Parkinson's Disease who are interested in a Breath, Sound, and Meditation Webinar. They must have mild to moderate symptoms (PAS score ≥12), be able to read English, and participate physically and mentally. Those with severe PD or conditions like major depression under medication, schizophrenia, or bipolar disorder cannot join.Check my eligibility
What is being tested?
The study tests if yoga practices like Isha Kriya, Nadi Shuddhi, and Nada Yoga improve mental health in Parkinson's patients compared to routine activities. Participants will be randomly assigned to either the yoga group or control group and followed up at four intervals over 24 weeks.See study design
What are the potential side effects?
Yoga interventions typically have minimal side effects but may include muscle soreness or strain. Since this involves gentle breathwork and meditation techniques, risks are considered low; however individual experiences may vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I want to attend the Breath, Sound, and Meditation Webinar.
Select...
I am physically and mentally fit to follow the study's requirements.
Select...
I am over 18 years old.
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I have been diagnosed with Parkinson's Disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ for phase 1 analysis: baseline to week 12. for phase 2 analysis: baseline to week 18.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for phase 1 analysis: baseline to week 12. for phase 2 analysis: baseline to week 18.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Anxiety
Change in Compliance
Secondary outcome measures
Change in GRID-Hamilton Depression Scale (HAMD)
Change in MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Change in Perceived Stress Scale (PSS)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment3 Interventions
Breathing and Wellness Webinar: a Yogic Breathing practice (Nadi Shuddhi) and two guided meditations (Isha Kriya and Nada Yoga).
Group II: Waitlisted Control GroupActive Control1 Intervention
This group will be asked to wait for 6 weeks before being introduced to the Breathing and Wellness Webinar intervention which includes a Yogic Breathing practice (Nadi Shuddhi) and two guided meditations (Isha Kriya and Nada Yoga).
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Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
836 Previous Clinical Trials
13,010,278 Total Patients Enrolled
Balachundar Subramaniam, MD, MPHPrincipal InvestigatorBeth Israel Deaconess Medical Center
3 Previous Clinical Trials
419 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I want to attend the Breath, Sound, and Meditation Webinar.I am unable to give consent for myself to join the study.I am physically and mentally fit to follow the study's requirements.My Parkinson's disease is in a severe stage.I am over 18 years old.You have a score of 12 or higher on the PAS scale.I have been diagnosed with Parkinson's Disease.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Group
- Group 2: Waitlisted Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current threshold for inclusion in this experiment?
"Affirmative. Clinicaltrials.gov attests that this clinical trial has been seeking participants since October 18th 2022 and was recently updated on November 15th 2022. The study aims to enrol 50 people from a single medical centre."
Answered by AI
Are recruitment efforts still underway for this research project?
"Clinicaltrials.gov attests that this trial is still recruiting participants, having been first published on October 18th 2022 and edited as recently as November 15th of the same year."
Answered by AI
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