An In-Person and Online Intervention for Parkinson Disease (UPGRADE-PD): Protocol for a Patient-Centered and Culturally Tailored 3-Arm Crossover Trial.

BACKGROUND

Dance for Parkinson's Disease (DfPD) is a dance program for individuals with Parkinson disease (PD). There is a lack of knowledge about the effect of this program on frailty and sarcopenia experienced by patients with PD. In addition, no randomized controlled trial to date has investigated either the possible differential effects of in-person versus online DfPD or the possible effects of DfPD on clinical parameters in Greek patients with PD.

OBJECTIVE

We aimed to assess the efficacy, safety, and feasibility of a culturally tailored and patient-centered DfPD program offered both in-person and online to Greek patients with early- to midstage PD.

METHODS

This is a 3-arm crossover randomized controlled trial (in-person DfPD vs online DfPD vs control) of UPGRADE-PD (Upbeating Greek Application of Dance in Parkinson's Disease). The experimental period will be 10 months, including three 2-month interventional periods of two 60-minute dance classes per week for each group (in-person DfPD vs online DfPD) versus a control group (nonintervention group), and two 2-month washout periods between each group for 40 Greek patients with early- to midstage PD. Assessments will be performed face-to-face 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 nonmovement PD symptoms, and BMI. Safety, feasibility, and patient 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 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, and 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 nonmovement symptoms, as well as on quality of life, sarcopenia, and frailty in people living with PD in Greece.

TRIAL REGISTRATION

ClinicalTrials.gov NCT06220084; https://clinicaltrials.gov/study/NCT06220084.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/65490.