Accepted for/Published in: JMIR Research Protocols
Date Submitted: Aug 16, 2024
Date Accepted: Mar 26, 2025
The UPbeating GReek Application of DancE in Parkinson’s Disease (UPGRADE-PD): study protocol for a patient-centered and culturally tailored crossover trial delivered both in-person and online.
ABSTRACT
Background:
Dance for Parkinson’s Disease (DfPD®) is a dance program for individuals with PD. There is lack of knowledge about the effect of the above program on PD patient’s frailty and sarcopenia. In addition, no randomized controlled trial to date has been conducted to investigate either the possible differential effect of in-person versus online DfPD® or the possible effect of DfPD® on any Greek PD patients’ clinical parameter.
Objective:
We aim to assess the efficacy, safety and feasibility of a culturally tailored and patient-centered DfPD® program offered both in-person and online in early-to-mid-stage Greek PD patients.
Methods:
This is a 3-arm crossover randomized controlled trial (in-person DfPD® vs online DfPD® vs Control), and the experimental period will be of 10 months, including three 2-month interventional periods of two 60min dance classes per week for each group (in-person DfPD® vs online DfPD®) versus control group (non-intervention group), and two 2-month washout periods between each group for 40 early-to-mid-stage PD Greek patients. Assessments will be face-to-face performed at baseline and at the end of each study period and will include quality of life, fatigue, depressive symptoms, stress, anxiety, sarcopenia, frailty, balance, cognitive functions, movement and non-movement PD symptoms, and body mass index. Safety, feasibility, and patient’s satisfaction for each dance intervention (in-person DfPD® vs online DfPD®) will be assessed as well.
Results:
The study protocol was approved by the Medical Ethics Committee of the Eginition’s University Hospital in September 2022, and the Research and Ethics Committee of the University of West Attica in October 2023, and funded in September 2023. The first participant was enrolled in April 2023, while the trial is currently ongoing, and will conclude in September 2024.
Conclusions:
The results of this study are expected to show the possible differential effect of a patient-centered and culturally tailored in-person vs online DfPD® intervention on several movement and non-movement symptoms, as well as on QoL, sarcopenia, and frailty in people living with PD in Greece. Clinical Trial: ClinicalTrials.gov (NCT06220084); https://clinicaltrials.gov/study/NCT06220084
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