Clinical trial NCT02509611: Effects of Yoga on Parkinson's Disease
Official title: Effects of Yoga on Redox Status, Motor Function and Psychosocial Well-being in Individuals With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Yoga
Parkinson's disease
redox status
motor function
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2015-07-28
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Redox status
timeFrame: 12 weeks
Secondary outcomes:
measure: Motor function
timeFrame: 12 weeks
measure: Motor function
timeFrame: 12 weeks
measure: Motor function
timeFrame: 12 weeks
measure: Cognitive function
timeFrame: 12 weeks
measure: Mood
timeFrame: 12 weeks
measure: Sleep quality
timeFrame: 12 weeks
measure: Physical activity level
timeFrame: 12 weeks
measure: Quality of Life
timeFrame: 12 weeks
Other outcomes:
measure: Yoga feasibility
timeFrame: Baseline and 12 weeks
measure: Yoga acceptability
timeFrame: 12 weeks
measure: Yoga program fidelity
timeFrame: 4 weeks, 8 weeks, and 12 weeks
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Corjena Cheung, PhD
role: PRINCIPAL_INVESTIGATOR
References: