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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Clemson University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 15, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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