An In-Person and Online Intervention for Parkinson Disease (UPGRADE-PD): Protocol for a Patient-Centered and Culturally Tailored 3-Arm Crossover Trial
Bibliographic record
Abstract
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.013 | 0.010 |
| Meta-epidemiology (narrow) | 0.005 | 0.003 |
| Meta-epidemiology (broad) | 0.009 | 0.004 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.003 | 0.002 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.006 | 0.006 |
| Insufficient payload (model declined to judge) | 0.036 | 0.007 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".