Therapeutic Yoga to Improve Function in Parkinson’s Disease

Overview

This is a single blind, randomized, wait-list controlled, phase II exploratory pilot study.

Full Title of Study: “Therapeutic Yoga to Improve Function in Parkinson’s Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2015

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.

Interventions

  • Other: Therapeutic yoga for people with Parkinson’s Disease
    • Held for 8 weeks, individuals participated in therapeutic yoga 60 minutes 2x/week.

Arms, Groups and Cohorts

  • Experimental: Experimental
    • 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.
  • No Intervention: Wait List Control
    • There was no intervention during the WLC.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Clemson University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Marieke Van Puymbroeck, PhD, Principal Investigator, Clemson University

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