Effects of Amazonian Dance on Motor and Non-motor Symptoms of People With Parkinson's: Study Protocol

Federal University of Rio Grande do Sul

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Behavioral: Nordic Walking; Behavioral: Amazonian Dance

Study type: Interventional

Funder types: Other

Identifiers

NCT06967493

CAAE: 75675023.9.0000.5327

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Dance

Experimental group

Description:

Dance intervention for 3 months, 2 times/week, 2 hours per week. Dance is a safe and effective form of activity, which has been used in PD population. Participants take part in a dance class specifically for people with PD lead by a qualified dance instructor. The dance class typically include a warm-up, dance related activities developed based on folk and popular dances from the Amazon region in the Brazilian North region and a cool-down.

Treatment:

Behavioral: Amazonian Dance

Control Group

Active Comparator group

Description:

Nordic Walking was chosen for the active control group because it is a well accepted, low-cost, safe and effective rehabilitation strategy for PwPD (SALSE-BETÁN et al, 2022).

Treatment:

Behavioral: Nordic Walking