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This is a single blind, randomized, wait-list controlled, phase II exploratory pilot study.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Wait List Control | No Intervention | There was no intervention during the WLC. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic yoga for people with Parkinson's Disease | Other | Held for 8 weeks, individuals participated in therapeutic yoga 60 minutes 2x/week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Freezing of Gait Questionnaire at 8 weeks | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marieke Van Puymbroeck, PhD | Clemson University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38588457 | Derived | Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3. | |
| 36602886 |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D015013 | Yoga |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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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 | 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 | 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 | 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 |
| Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D026241 |
| Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |