Abstract
Introduction Parkinson’s Disease (PD) is commonly treated with the dopamine precursor, levodopa, which is used in antiparkinsonian therapy. After several years of taking this medication, many individuals with PD experience medication-related motor fluctuations (MRMF), a.k.a., OFF-time. OFF-time is one of the most disconcerting features of PD when troubling motor and non-motor symptoms previously alleviated by levodopa return. Exercise, specifically dance, could beneficially address OFF-time and enhance quality of life (QOL) and independence in people with PD.
Methods
This assessor-blinded randomized controlled trial (1:1) [NCT04122690] included 45 participants with PD (70.1±7.27 years, 73% male, 2.30±0.61 Hoehn & Yahr stage), who were randomized into 30 hours of PDAE or WALK over 3 months. Psychosocial questionnaires, MDS-UPDRS, and 3-day OFF-state diaries were administered at baseline and three-month timepoints to measure reported OFF-time, QOL, independence, and disease severity. Within-group comparisons were analyzed using paired t-tests, and between-group comparisons were analyzed using independent t-tests and a linear mixed-effects model.
Results
After three months, PDAE reduced OFF-time and improved motor symptoms. Compared to WALK, PDAE also reduced OFF-time, improved motor symptoms, and enhanced the experience of daily living.
Conclusion
PDAE is superior to WALK and is an effective adjunctive therapy to help improve OFF-time and QOL in individuals with PD after three months. Further studies are needed to determine the relationship between improving OFF-time and quality of life.
Competing Interest Statement
The authors have declared no competing interest.
Clinical Trial
NCT04122690
Funding Statement
This study was funded by the United States Department of VA Merit Award 1 I01 RX002967. Daniel Huddleston was supported by grant funding from the NIH (NIH-NINDS 1K23NS105944-01A1) and the American Parkinsons Disease Association Center for Advanced Research at Emory University.
Author Declarations
I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
The Institutional Review Board (IRB) of Emory University and the Research and Development Committee of the Atlanta Veterans Affairs Medical Center gave ethical approval for this work.
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
Yes
I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
Yes
Data Availability
All data produced in the present study are available upon reasonable request to the authors
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