Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT06967493
Brief Summary:
This randomized controlled trial aims to evaluate the effects of a 12-week Amazonian dance program on cognitive and motor symptoms in people with Parkinson's disease (PD), comparing outcomes between participants in the intervention and those in an alternative control intervention.
Detailed Description:
Experimental Design: Randomized controlled single-blind trial with four parallel groups. Study sites include the Federal University of Rio Grande do Sul (South Region, Brazil) and the Federal University of Pará (North Region, Brazil).
Participants: 80 adults aged 50 to 80 years with a clinical diagnosis of idiopathic Parkinson's disease, in stages I-III of the Hoehn \& Yahr Scale, under stable pharmacological treatment for at least one year. Participants will be recruited from community health services, Parkinson's associations, and university-affiliated health units in Northern and Southern Brazil.
Interventions:
Amazonian Dance Groups (North and South): Participants will engage in twice-weekly dance sessions for 12 weeks (24 sessions total), including movement practices inspired by Lundum and Carimbó dances, choreographic improvisation, and activities involving memory, storytelling, balance, and mobility.
Control Groups (North and South): Participants will receive a structured non-dance intervention over the same 12-week period. This control activity will consist sessions related to general well-being, physical activity, and quality of life, without dance training.
Outcomes:
Primary Outcome: Cognition (assessed by MoCA, Stroop, and Tab-CAT tools). Secondary Outcomes: Language (TELL), depressive and anxiety symptoms (GDS-15, PAS), quality of life (PDQ-39), functional mobility (TUG), fear of falling (FES-I), and freezing of gait (FOGQ). Experience with Dance, Sociodemographic and clinical data will also be collected.
Data Analysis: Descriptive statistics will report means and standard deviations. Group comparisons over time will be analyzed using Generalized Estimating Equations (GEE) with Bonferroni post-hoc tests. Statistical significance is set at p\<0.05. Effect sizes will be interpreted using Cohen's d (small = 0.2, medium = 0.5, large = 0.8), with 95% confidence intervals reported. Analyses will include intention-to-treat, considering participants with at least 80% adherence.
Study:
NCT06967493
Study Brief:
Protocol Section:
NCT06967493