Therapeutic Yoga to Improve Function in Parkinson's Disease

September 14, 2016 updated by: Clemson University
This is a single blind, randomized, wait-list controlled, phase II exploratory pilot study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Therapeutic yoga for people with Parkinson's Disease
Held for 8 weeks, individuals participated in therapeutic yoga 60 minutes 2x/week.
Other Names:
  • Yoga
No Intervention: Wait List Control
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
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.
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
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
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
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
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
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.
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
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.
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
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.
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
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.
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
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.
baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clemson University

Investigators

  • Principal Investigator: Marieke Van Puymbroeck, PhD, Clemson University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

September 5, 2016

First Submitted That Met QC Criteria

September 14, 2016

First Posted (Estimate)

September 15, 2016

Study Record Updates

Last Update Posted (Estimate)

September 15, 2016

Last Update Submitted That Met QC Criteria

September 14, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00041068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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