Parkinson's Disease
Conditions
Keywords
yoga, function, Parkinson's disease, gait, balance
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.
Interventions
OTHERTherapeutic yoga for people with Parkinson's Disease
Held for 8 weeks, individuals participated in therapeutic yoga 60 minutes 2x/week.
Sponsors
Clemson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Movement Disorders Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale at 8 weeks | 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. |
| Change in Mini BESTest at 8 weeks | 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 |
| Change in Functional Gait Assessment at 8 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Activity Constraints Scale at 8 weeks | 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. |
| Change in Freezing of Gait Questionnaire at 8 weeks | 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. |
| Change in Parkinson's Disease Questionnaire (PDQ-8) at 8 weeks | 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. |
| Change in Parkinson's Fatigue Scale at 8 weeks | 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. |
| Change in Activity Balance Confidence Scale at 8 weeks | 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. |
Outcome results
None listed