Therapeutic Yoga to Improve Function in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
This is a single blind, randomized, wait-list controlled, phase II exploratory pilot study.

Detailed Description
-----------------
This is a single blind, randomized, wait-list controlled, phase II exploratory pilot study utilizing an after-trial embedded mixed methods approach that will examine the efficacy of therapeutic yoga as a rehabilitation strategy for individuals with PD to improve balance and reduce fear of falling (FoF). Potential participants will have a FoF in order to enter the study. An after-trial embedded mixed methods design will be employed in this study and will include the collection of qualitative data to assist in the overall interpretation of the more heavily weighted quantitative trial data. Adding qualitative methods will serve as a post-hoc analysis capturing participant perceptions of the relationships between the yoga intervention and various outcomes. More specifically, the qualitative data will aide in explaining the link between the various yoga techniques and mechanisms that participants attribute to improved balance, reduced FoF, and other bio-psychosocial outcomes and experiences. Qualitative data will be collected using focus group interviews with participants in the yoga group at the end of the class in week 8.

Official Title
-----------------
Therapeutic Yoga to Improve Function in Parkinson's Disease

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Other: Therapeutic yoga for people with Parkinson's Disease


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Parkinson's Disease with a rating of 1.5-4 on the Modified Hoehn and Yahr Scale of Parkinson's Disease Progression Endorsement of FoF,44 able to stand and walk 10 meters with or without an assistive device >18 years old; able to speak English Score >4 out of 6 on the short Mini Mental Status Exam Able and willing to attend twice weekly sessions for 8 weeks Exclusion Criteria: People with self-reported life expectancy <12 months Inability to attend sessions due to transportation issues Current involvement with other physical activity (including yoga), rehabilitation, or other intervention studies Inability or refusal to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>The experimental group is the group that received yoga. The individuals originally assigned to the WLC who completed the yoga intervention AFTER the 8 weeks WLC period also are considered part of the experimental group. | Other: Therapeutic yoga for people with Parkinson's Disease<br>* Held for 8 weeks, individuals participated in therapeutic yoga 60 minutes 2x/week.<br>* Other names: Yoga;|
| No Intervention: Wait List Control<br>There was no intervention during the WLC. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Movement Disorders Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale at 8 weeks | A performance based assessment of motor function. | baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period | 
| Change in Mini BESTest at 8 weeks | clinical balance assessment tool that targets 4 balance control systems, including anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait | baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period | 
| Change in Functional Gait Assessment at 8 weeks | assesses postural stability during 10 walking tasks | baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Freezing of Gait Questionnaire at 8 weeks | frequency of freezing of gait and disturbances in gait. | baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period | 
| Change in Parkinson's Fatigue Scale at 8 weeks | measures level of fatigue and impact of fatigue on daily functioning. | baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period | 
| Change in Activity Balance Confidence Scale at 8 weeks | Examines perceived confidence in performing various ambulatory activities with falling. | baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period | 
| Change in Activity Constraints Scale at 8 weeks | Measures perceived constraints to activity participation. | baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period | 
| Change in Parkinson's Disease Questionnaire (PDQ-8) at 8 weeks | Measures quality of life for individuals with PD. | baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
yoga, function, Parkinson's disease, gait, balance