Effects of Yoga on Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The study's purpose is to assess the effect of yoga on measures of oxidative stress (i.e.
      reduction-oxidation [redox] status); motor function; and psychosocial well-being, and the
      feasibility and acceptability of implementing a Hatha yoga program in PD subjects.
    

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:

        1. Primary endpoint: redox status at 12 weeks.

        2. Secondary endpoint: motor function (gait, balance, strength, flexibility, physical
           activity level) and psychosocial well-being (mood, cognitive function, sleep quality,
           QoL) at 12 weeks.

        3. 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.
    

Intervention name(s): Hatha yoga
Intervention type(s): Other
Intervention description(s): 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 intervention name(s): Yoga
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Yoga; Parkinson's disease; redox status; motor function