- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02509611
Effects of Yoga on Parkinson's Disease (HYPD)
Effects of Yoga on Redox Status, Motor Function and Psychosocial Well-being in Individuals With Parkinson's Disease
Study Overview
Detailed Description
The specific aims of this study are:
Aim 1: Determine the effect of a 12-week Hatha yoga program on redox status in individuals with PD.
Hypothesis 1a: Participants in the intervention group will have greater increases in total GSH levels and GSH: GSSG ratios from baseline than participants in the wait-list control group.
Hypothesis 1b: Compared to pre-intervention, wait-list participants will have higher total GSH levels and GSH: GSSG ratios after receiving the intervention.
Aim 2: Examine the effect of a 12-week Hatha yoga program on motor function (gait, balance, strength, flexibility, and physical activity level) and psychosocial well-being (mood, cognitive function, sleep quality, QoL) in individuals with PD.
Hypothesis 2a: Participants in the intervention group will have greater improved scores on the motor Unified Parkinson's Disease Rating Scale (UPDRS), range of motion (ROM), biomechanical force platforms tests, Beck Depression Inventory (BDI), Parkinson's Disease Sleep Scale (PDSS), Parkinson's Disease Quality of Life Questionnaire (PDQUALIF), and Montreal Cognitive Assessment than wait-list participants.
Hypothesis 2b: Compared to pre-intervention, wait-list participants will have improved scores on the motor UPDRS, ROM, biomechanical force platforms tests, BDI, PDSS, and PDQUALIF after receiving the intervention.
Aim 3: Determine the feasibility and acceptability of Hatha yoga program for PD subjects, and fidelity of the yoga program.
Hypothesis 3: The program retention rate will be > 70%, the average attendance rate will be > 70% per class, and no yoga related adverse events will be reported during the study. Most participants will react positively to the yoga program.
Methods Design and Sample A randomized controlled trial design with two groups will be used: a treatment group (n=10) and a wait-list control group (n=10). After randomization, participants in the treatment group will receive 60-minute biweekly Hatha yoga for 12 weeks, and participants in the wait-list group will receive no intervention. Wait-list participants will also serve as their own control and receive the same yoga intervention at the end of 12 weeks when the treatment group completed their program. Participants will be recruited from clinics via flyers, and through local and national PD networks.
Yoga programs that were used in previous PD studies will be incorporated into the design of the proposed intervention program. 19, 31, 32 Two yoga experts who are specialized in musculoskeletal/neurological disorders will review the program. The yoga intervention classes will be taught by a Registered Yoga Teacher. Classes will be held at a community center in St. Louis Park.
Resting blood samples will be collected at the Clinical Translational Science Institute (CTSI) facility by a trained phlebotomist and total GSH and redox status analyzed by a co-investigator. Biomechanical assessment and survey data will be collected in the Konczak laboratory by a trained graduate research assistant. All data will be collected at baseline and 12 weeks from both treatment and wait-list control groups. The 12 weeks data from the wait-list participants will serve as their second baseline before they began the intervention program. Their post intervention data will be collected at 24 weeks post randomization to increase power.
Study Endpoints:
- Primary endpoint: redox status at 12 weeks.
- Secondary endpoint: motor function (gait, balance, strength, flexibility, physical activity level) and psychosocial well-being (mood, cognitive function, sleep quality, QoL) at 12 weeks.
- Tertiary endpoint: yoga feasibility, acceptability, and program fidelity. The sample size of 20, with attrition rate of 20%, has 78% power to detect an effect size of 1.0 when comparing the change before and after the yoga intervention. Both between groups and within group comparisons will be conducted. Descriptive statistics will be used to analyze and report demographic, feasibility, and acceptability data. Inferential statistics (t-test or non-parametric equivalent such as Mann-Whitney, and chi-square test) will be used to analyze the objective and subjective outcomes of Aims 1 & 2. The α level will be set at ≤ .05.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Individuals diagnosed with idiopathic PD;
- On optimized dopaminergic therapy for 4 weeks prior to enrollment; and
- Have not practiced any form of yoga regularly (more than 2 days a week) in the past 6 months; and
- Not currently participating in a supervised exercise program more than 2 days a week
Exclusion Criteria:
- Atypical Parkinsonism or other significant brain conditions such as a stroke;
- Fell more than once in the past 3 months;
- Moderate to severe cognitive impairment (scored <26) as indicated by the Montreal Cognitive Assessment;
- Decline in immune function such as pneumonia or systemic infection;
- Spinal fusion or other orthopedic surgery in the past 6 months;
- Unstable cardiovascular conditions;
- Significant mental disease or psychosis;
- Not able to ambulate 6 meters steadily without assistive device.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Immediate treatment
Participants who are randomly assigned to the immediate treatment group will receive 60-minute biweekly Hatha yoga for 12 weeks.
|
Yoga programs that were used in previous PD studies will be incorporated into the design of the proposed intervention program.
Two yoga experts who are specialized in musculoskeletal/neurological disorders will review the program.
The yoga intervention classes will be taught by a Registered Yoga Teacher.
The 60 minute long yoga session will be held twice a week for 12 weeks at a community center in St. Louis Park.
Other Names:
|
ACTIVE_COMPARATOR: Waitlist control
Participants who are randomly assigned to the wait-list group will receive no intervention during the first 12 weeks.
Not only will they serve as the comparative group, they will also serve as their own control and receive the same yoga intervention at the end of 12 weeks when the immediate treatment group completed their program.
|
Yoga programs that were used in previous PD studies will be incorporated into the design of the proposed intervention program.
Two yoga experts who are specialized in musculoskeletal/neurological disorders will review the program.
The yoga intervention classes will be taught by a Registered Yoga Teacher.
The 60 minute long yoga session will be held twice a week for 12 weeks at a community center in St. Louis Park.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Redox status
Time Frame: 12 weeks
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The antioxidant glutathione (GSH) and the GSH: glutathione disulfide (GSSG) ratio will be measured at baseline and at the end of the program.
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motor function
Time Frame: 12 weeks
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Gait and strength will be measured using motor Unified Parkinson's Disease Rating Scale (UPDRS) biomechanical force platforms tests: Force plate system (OR6-5 AMTI) - 2D sway path length of center of mass during 20s standing.
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12 weeks
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Motor function
Time Frame: 12 weeks
|
Balance will be measured using the motor UPDRS and biomechanical force platforms tests: Force plate system (OR6-5 AMTI) - range of anterior-posterior and medial-lateral away, total sway area, and duration of one-legged stance.
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12 weeks
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Motor function
Time Frame: 12 weeks
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Flexibility will be evaluated by measuring range of motion using a goniometer.
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12 weeks
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Cognitive function
Time Frame: 12 weeks
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Cognitive function will be evaluated using the Montreal Cognitive Assessment test.
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12 weeks
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Mood
Time Frame: 12 weeks
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Mood will be evaluated using the Beck Depression Inventory scale.
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12 weeks
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Sleep quality
Time Frame: 12 weeks
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Sleep quality will be evaluated using the Parkinson's Disease Sleep Scale.
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12 weeks
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Physical activity level
Time Frame: 12 weeks
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Longitudinal Aging Study Amsterdam scale will be used to evaluate physical activity levels in PD subjects.
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12 weeks
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Quality of Life
Time Frame: 12 weeks
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Parkinson's Disease Quality of Life Questionnaire will be used.
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12 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Yoga feasibility
Time Frame: Baseline and 12 weeks
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Number of eligible subjects, total average number of class attendance, number and type of yoga related adverse events, and retention rate.
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Baseline and 12 weeks
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Yoga acceptability
Time Frame: 12 weeks
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A short questionnaire will be used to evaluate participants' self-report satisfaction with the yoga program, perceived appropriateness of the program, and intention to continue use of the program.
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12 weeks
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Yoga program fidelity
Time Frame: 4 weeks, 8 weeks, and 12 weeks
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The PI will evaluate the accuracy/consistency of the intervention program.
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4 weeks, 8 weeks, and 12 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1506M74261
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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