Yoga as a Complementary and Alternative Management (CAM) Approach for Psychological Wellbeing in Parkinson’s Disease (PD)

          Yoga as a Complementary and Alternative Management (CAM) Approach for Psychological Wellbeing in Parkinson’s Disease (PD)

Introduction

Objective: To evaluate the effects of yoga on the psychological wellbeing of people with mild-to-moderate Parkinson’s Disease (PD) compared to stretching and resistance training exercises.

Background: PD affects approximately 10 million people globally, characterized by motor symptoms and often accompanied by psychological distress such as anxiety and depression. The study explores yoga as a CAM therapy to address these non-motor symptoms.

Methods

Design: Community-based, single-blind, randomized trial.

Participants: 126 subjects with mild-to-moderate PD, divided into two groups: Yoga (n=63) and Stretching and Resistance Exercise (n=63).

Intervention:

Yoga Group: Weekly 90-minute yoga sessions for 8 weeks.

Control Group: Weekly 60-minute stretching and resistance exercise sessions for 8 weeks.

Primary Outcome Measure: Level of psychological distress using the Hospital Anxiety and Depression Scale.

Secondary Outcome Measures: Severity of motor symptoms, mobility, balance, fall risk, spiritual wellbeing, and HRQoL.

Results (Expected)

Primary Outcome: Improvement in psychological distress levels in the yoga group compared to the control group.

Secondary Outcomes: Potential improvements in motor symptoms, mobility, balance, spiritual wellbeing, and HRQoL.

Discussion

Significance: This study is pivotal as the first randomized trial comparing the effect of yoga with stretching and resistance training in a PD population.

Implications: Results may establish yoga as a viable therapeutic option for managing psychological distress in PD patients, offering a holistic approach encompassing psychological, physiological, and spiritual wellbeing.

Future Directions: The findings could inform future research, clinical practice, and policy-making in PD management.

Conceptual Framework

Theory of Self-transcendence: The study is underpinned by this theory, suggesting that yoga helps individuals with PD in self-transcendence, leading to improved wellbeing despite the challenges of the disease.

Trial Registration

Registry: WHO Primary Registry – Chinese Clinical Trials Registry (ChiCTR)

Registration Number: CUHK_CCRB00522

Registration Date: 8 October 2016

Electronic Supplementary Material

Availability: Additional material available in the online version of the article.

Yoga as a Complementary and Alternative Management (CAM) Approach for Psychological Wellbeing in Parkinson’s Disease (PD) - Continued

Aim and Hypotheses

Aim: To examine the effect of yoga on the psychological, physiological, spiritual wellbeing, and Health-Related Quality of Life (HRQoL) in individuals with mild-to-moderate PD.

Hypotheses:

The structured mindfulness yoga program will improve psychological, physiological, spiritual wellbeing, and HRQoL in individuals with mild-to-moderate PD.

The structured mindfulness yoga program will be superior to stretching and resistance training exercise in improving these outcomes.

Design

Type: Single-blinded randomized controlled trial (RCT).

Randomization: 1:1 ratio using permuted block randomization with a block size of 8.

Tools: CONSORT flow diagram and SPIRIT Figure for study design illustration.

Study Population

Recruitment: Through PD support groups and specialized outpatient clinics.

Inclusion Criteria: Idiopathic PD (stage I to III on Hoehn and Yahr scale), age above 18, ability to stand and walk unaided or with assistive devices, ability to give written consent.

Exclusion Criteria: Treatment for mental disorders or uncontrolled mood disorders, participation in other trials, cognitive impairment (abbreviated mental test score < 6), other debilitating conditions.

Sample Size

Calculation Basis: Effect size of 0.59 for depression and anxiety from previous studies.

Total Participants: 126 subjects (63 per group), considering an attrition rate of 25%.

Sampling and Recruitment Strategies

Approach: Convenience sampling.

Channels: PD support groups, outpatient clinics, printed flyers, newsletters, and online registration.

Interventions

Experimental Group: 8-week structured yoga program, 60-min sessions weekly, plus 20-min home-based practice twice a week.

Control Group: 8-week stretching and resistance exercise program, 60-min sessions weekly, plus 20-min home-based practice twice a week.Yoga Protocol: Includes controlled breathing, mindfulness practice, and 12 basic Hatha yoga poses (sun salutations).

Stretching and Resistance Exercise Protocol: Modified from validated studies for older adults with osteoarthritis.

Validity and Reliability

Content Validity: Yoga protocol reviewed by a panel of experts (neurologist, PD nurse specialist, physical education researcher, physiotherapist, occupational therapist, yoga instructors).

Modifications: Based on expert feedback, certain yoga poses were modified for safety and relevance.

I-CVI: Achieved 1.0 after two rounds of review, ensuring good content validity.

Randomization and Allocation Concealment

Method: Computer-based permuted block randomization.

Allocation Concealment: Sealed opaque envelopes with randomized group assignments.

Blinding

• Type: Single-blind RCT.
• Implementation: Outcome assessor blinded to subject allocation, independent from group allocation.
• Challenges: Difficulty in blinding participants due to the nature of the intervention.
• Strategies to Minimize Bias:
• Participants blinded to study hypotheses.
• Similar expected outcomes stated for both groups.
• Reminders for participants not to disclose group status.

Attrition and Missing Data

• Anticipated Rate: 25% attrition considered.
• Strategies to Reduce Attrition:
• Emphasizing importance of complete participation.
• Flexible follow-up arrangements.
• Regular contact via phone and reminders.
• Clear explanation of study procedures and health implications.

Adherence

• Instructions to Participants: Follow normal medication schedule, avoid new exercise programs.
• Facilitation Tools: Picture-based education booklets, self-reported activity logs.
• Monitoring: Class attendance checks, documentation of absenteeism reasons.

Outcomes

• Primary Outcome: Psychological wellbeing measured by the Hospital Anxiety and Depression Scale (HADS).
• Secondary Outcomes:
• Motor symptoms (MDS-UPDRS-III).
• Mobility, balance, and fall risk (TUG).
• Spiritual wellbeing (HWS).
• HRQoL (PDQ-8).

Data Collection

• Process: Screening, informed consent, baseline data collection.
• Timing: Assessments at baseline, post-intervention (2 months), and follow-up (3 months).
• Condition: Assessments conducted during “on” state of medication.

Data Analysis

• Approach: Descriptive statistics, GEE models.
• Analysis Principle: Intention-to-treat.
• Software: IBM SPSS 22.0.
• Significance Level: P-value set at 0.05.
• Reporting Guidelines: CONSORT 2010 and its extension to nonpharmacological interventions.

Ethical Considerations

• Ethics Approval: Obtained from The Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee.
• Registration: WHO Primary Registry – Chinese Clinical Trials Registry.
• Confidentiality: Unique identification numbers, restricted data access.
• Compliance: Declaration of Helsinki.

Risks and Safety

• Safety Measures: Adequate warm-up and cool-down, use of props, tailored postures.
• Monitoring: Reporting of adverse events, clinical trial insurance.
• Stopping Rules: Based on risk of serious adverse events.

Pilot Study

• Conduct: 10 participants, same criteria, 8-week yoga program.

Findings:

• High satisfaction and perceived benefits.
• Significant improvements in psychological distress and holistic wellbeing.

Adjustments: Increase class duration from 60 to 90 minutes for more mindfulness practice.

Yoga as a Complementary and Alternative Management (CAM) Approach for Psychological Wellbeing in Parkinson’s Disease (PD) 

Discussion

Contribution to Existing Research:

• Aligns with previous findings on yoga improving physical wellbeing in PD.
• Expands research to include psychological distress management in chronic illnesses.

Advantages of Yoga Intervention:

Minimal side effects and low cost.

• Potential for long-term, community-based self-help in PD patients.

Research Significance:

• Structured, evidence-based yoga protocols for chronic illnesses.
• Focus on feasibility, acceptance, and practicability in PD patients.

Impact on Management Approaches:

• Integrative, interdisciplinary focus.
• Empowering patients towards active self-care and mindful awareness.

Limitations

Participation Bias:

• Voluntary participation, limited to mild-to-moderate PD stages.
• Exclusion of patients under psychiatric treatment.
• Strategies to mitigate: Diverse recruitment strategies.

Single-Blind Design Risks:

Potential overestimation of treatment effects.

Strategies to minimize bias previously discussed.

Trial Status

Commencement: March 2017.

Estimated Completion: March 2018.

Additional Information

Additional Files:

SPIRIT Checklist.

Yoga Educational Booklet.

Acknowledgements:

• Contributions from expert panel and professional advisors.

Funding: None.

Data Availability: Not applicable.

Abbreviations

CAM, GEE, HADS, HRQoL, HWS, I-CVI, ITT, MBCT, MBSR, MDS-UPDRS-III, PD, PDQ-8, RCT, TUG.

Authors’ Contributions

Involvement:

• Conception and design of the study.
• Drafting and revising the manuscript.
• Supervision of the project.

Team: JKYY, JKCY, MA, VMCT, HCYL.

Ethics and Consent

Ethics Approval: Obtained from The Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee.

Consent: Written informed consent required from participants.