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

Официальное название

"Amazonian Dance for Parkinson": a Protocol Study for a Randomized Clinical Trial on Motor and Non-motor Symptoms of People With Parkinson's.

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Amazonian Dance
  Dance intervention consists of 24 Amazonian Dance, 2 times/week, lasting 1 hour, over a period of 12 weeks. Classes will be taught by qualified dance professionals with experience teaching PwPD and will take place in a specific practice room (air-conditioned, spacious, and leveled), with adequate facilities, floors, chairs, bars, mirrors, and sound system. Classes will be divided into 4 parts. The part 1 (10-15 min.) consists of welcoming students, warm-up exercises, and body awareness activiti
• Поведенческое Nordic Walking
  The Nordic walking protocol consists of 3 moments: warm-up (10min), main part (40min) and final part (10min). At the beginning of the activity, a joint warm-up is performed and free walking, without poles, at a comfortable speed. Then, in the main part of the class, the participants performed an individual and daily training that is inserted in their general training cycle, elaborated from the specific and individual functional capacity, measured from the application of the 6-minute walk test. I

Первичные конечные точки

• Cognition [Срок оценки: Change from baseline at 3 months]
• 1.1 - Cognition - Dot-couting [Срок оценки: Change from baseline at 3 months]
• 1.2 - Cognition - Set-shifting [Срок оценки: Change from baseline at 3 months]
• 1.3 - Cognition - Flanker [Срок оценки: Change from baseline at 3 months]
• 1.4 - Cognition - Animal Fluency [Срок оценки: Change from baseline at 3 months]
• 1.5 - Cognition - MoCA [Срок оценки: Change from baseline at 3 months]
• Language [Срок оценки: Change from baseline at 3 months]

Вторичные конечные точки (7)

• Anxiety symptoms [Срок оценки: Change from baseline at 3 months]
• Depressive symptoms [Срок оценки: Change from baseline at 3 months]
• Quality of life symptoms [Срок оценки: Change from baseline at 3 months]
• Levels of Hope [Срок оценки: Change from baseline at 3 months]
• Functional Mobility [Срок оценки: Change from baseline at 3 months]
• Fall symptoms [Срок оценки: Change from baseline at 3 months]
• Gait freezing [Срок оценки: Change from baseline at 3 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Бразилия · 2 центра

• Universidade Federal do Pará — Castanhal
• Universidade Federal do Rio Grande do Sul — Porto Alegre

Идентификаторы

NCT: NCT06967493 · CAAE: 75675023.9.0000.5327

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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