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
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
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
NCT ID
NCT02902510
First Posted
September 5, 2016
Last Updated
September 14, 2016
Sponsor
Clemson University
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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Therapeutic Yoga to Improve Function in Parkinson's Disease
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