Clinical trial NCT06967493: Effects of Amazonian Dance on Motor and Non-motor Symptoms of People With Parkinson's: Study Protocol
Official title: "Amazonian Dance for Parkinson": a Protocol Study for a Randomized Clinical Trial on Motor and Non-motor Symptoms of People With Parkinson's.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Dance
Cognition
Non-motor symptoms
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Universidade Federal do Para
First posted: 2025-05-13
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of PD according to the London Brain Bank Criteria;
* Able to understand the verbal instructions for the tests;
* Hoehn and Yahr (H\&Y) stages I-III
* ≥ 1 year undergoing medical treatment for PD with regular use of anti-parkinsonian drugs
* Capability to participate will be based on the Unified Parkinson's Disease Rating Scale -motor examination

Exclusion Criteria:

* Recent surgeries,
* Deep brain stimulation (DBS);
* Other associated neurological diseases or chronic diseases
* Fitted with a pacemaker;
* Prostheses in the lower limbs;

Primary outcomes:
measure: Cognition
timeFrame: Change from baseline at 3 months
measure: 1.1 - Cognition - Dot-couting
timeFrame: Change from baseline at 3 months
measure: 1.2 - Cognition - Set-shifting
timeFrame: Change from baseline at 3 months
measure: 1.3 - Cognition - Flanker
timeFrame: Change from baseline at 3 months
measure: 1.4 - Cognition - Animal Fluency
timeFrame: Change from baseline at 3 months
measure: 1.5 - Cognition - MoCA
timeFrame: Change from baseline at 3 months
measure: Language
timeFrame: Change from baseline at 3 months
Secondary outcomes:
measure: Anxiety symptoms
timeFrame: Change from baseline at 3 months
measure: Depressive symptoms
timeFrame: Change from baseline at 3 months
measure: Quality of life symptoms
timeFrame: Change from baseline at 3 months
measure: Levels of Hope
timeFrame: Change from baseline at 3 months
measure: Functional Mobility
timeFrame: Change from baseline at 3 months
measure: Fall symptoms
timeFrame: Change from baseline at 3 months
measure: Gait freezing
timeFrame: Change from baseline at 3 months
Other outcomes:
measure: PD motor symptoms
timeFrame: Change from baseline at 3 months
measure: Experience with Dance
timeFrame: baseline
Locations:
city: Castanhal
country: Brazil
facility: Universidade Federal do Pará
state: Pennsylvania
city: Porto Alegre
country: Brazil
facility: Universidade Federal do Rio Grande do Sul
state: RS
Study officials:
References: