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Therapeutic Yoga to Improve Function in Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Therapeutic yoga for people with Parkinson's Disease
Sponsored by
Clemson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Parkinson's Disease focused on measuring yoga, function, Parkinson's disease, gait, balance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Experimental

    Wait List Control

    Arm Description

    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.

    There was no intervention during the WLC.

    Outcomes

    Primary Outcome Measures

    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.
    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
    Change in Functional Gait Assessment at 8 weeks
    assesses postural stability during 10 walking tasks

    Secondary Outcome Measures

    Change in Freezing of Gait Questionnaire at 8 weeks
    frequency of freezing of gait and disturbances in gait.
    Change in Parkinson's Fatigue Scale at 8 weeks
    measures level of fatigue and impact of fatigue on daily functioning.
    Change in Activity Balance Confidence Scale at 8 weeks
    Examines perceived confidence in performing various ambulatory activities with falling.
    Change in Activity Constraints Scale at 8 weeks
    Measures perceived constraints to activity participation.
    Change in Parkinson's Disease Questionnaire (PDQ-8) at 8 weeks
    Measures quality of life for individuals with PD.

    Full Information

    First Posted
    September 5, 2016
    Last Updated
    September 14, 2016
    Sponsor
    Clemson University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02902510
    Brief Title
    Therapeutic Yoga to Improve Function in Parkinson's Disease
    Official Title
    Therapeutic Yoga to Improve Function in Parkinson's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2015 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    April 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Clemson University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson's Disease
    Keywords
    yoga, function, Parkinson's disease, gait, balance

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Wait List Control
    Arm Type
    No Intervention
    Arm Description
    There was no intervention during the WLC.
    Intervention Type
    Other
    Intervention Name(s)
    Therapeutic yoga for people with Parkinson's Disease
    Other Intervention Name(s)
    Yoga
    Intervention Description
    Held for 8 weeks, individuals participated in therapeutic yoga 60 minutes 2x/week.
    Primary Outcome Measure Information:
    Title
    Change in Movement Disorders Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale at 8 weeks
    Description
    A performance based assessment of motor function.
    Time Frame
    baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period
    Title
    Change in Mini BESTest at 8 weeks
    Description
    clinical balance assessment tool that targets 4 balance control systems, including anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait
    Time Frame
    baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period
    Title
    Change in Functional Gait Assessment at 8 weeks
    Description
    assesses postural stability during 10 walking tasks
    Time Frame
    baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period
    Secondary Outcome Measure Information:
    Title
    Change in Freezing of Gait Questionnaire at 8 weeks
    Description
    frequency of freezing of gait and disturbances in gait.
    Time Frame
    baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period
    Title
    Change in Parkinson's Fatigue Scale at 8 weeks
    Description
    measures level of fatigue and impact of fatigue on daily functioning.
    Time Frame
    baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period
    Title
    Change in Activity Balance Confidence Scale at 8 weeks
    Description
    Examines perceived confidence in performing various ambulatory activities with falling.
    Time Frame
    baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period
    Title
    Change in Activity Constraints Scale at 8 weeks
    Description
    Measures perceived constraints to activity participation.
    Time Frame
    baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period
    Title
    Change in Parkinson's Disease Questionnaire (PDQ-8) at 8 weeks
    Description
    Measures quality of life for individuals with PD.
    Time Frame
    baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marieke Van Puymbroeck, PhD
    Organizational Affiliation
    Clemson University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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