Clinical trial NCT02902510: Therapeutic Yoga to Improve Function in Parkinson's Disease
Official title: Therapeutic Yoga to Improve Function in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: yoga
function
Parkinson's disease
gait
balance
Lead sponsor: Clemson University
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in Movement Disorders Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale at 8 weeks
timeFrame: baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period
measure: Change in Mini BESTest at 8 weeks
timeFrame: baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period
measure: Change in Functional Gait Assessment at 8 weeks
timeFrame: baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period
Secondary outcomes:
measure: Change in Freezing of Gait Questionnaire at 8 weeks
timeFrame: baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period
measure: Change in Parkinson's Fatigue Scale at 8 weeks
timeFrame: baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period
measure: Change in Activity Balance Confidence Scale at 8 weeks
timeFrame: baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period
measure: Change in Activity Constraints Scale at 8 weeks
timeFrame: baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period
measure: Change in Parkinson's Disease Questionnaire (PDQ-8) at 8 weeks
timeFrame: baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period
Other outcomes:
Locations:
Study officials:
affiliation: Clemson University
name: Marieke Van Puymbroeck, PhD
role: PRINCIPAL_INVESTIGATOR
References: