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

Condition(s) studied

Investigational drug(s) / intervention(s)

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 activities. In the Part 2 (10-15 min.) Weight transfer activities, static and dynamic balance, motor coordination, strengthening of lower and upper limbs will be carried out. The part 3 (25-30 min.) will be based on the Amazonian Lundum and Carimbó dances. In the part 4 (5-10 min.), the final part of the class, the calm down activity will be carried out, with breathing, stretching and relaxation activities.

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. In the final part, return to calm and stretching.

Study 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.

Eligibility

Primary outcome measure(s)

• Cognition — Change from baseline at 3 months
  Cognition will be assessed in two ways using traditional pen-and-paper tests and incorporating innovative instruments and using digital technology. Executive function and attention will be measured using the Tablet-based Cognitive Assessment (Tab-CAT) application, developed for the efficient detection of mild neurocognitive disorders, which assesses cognitive abilities including memory, executive/speed, visuospatial and language (Possin et al., 2018). In this battery, the Dot-counting, Set-shifting, Flanker, and Animal Fluency tests will be used. The Montreal Cognitive Assessment (MoCA) Brazilian version (Hobson, 2015) will be used to screen for mild cognitive impairment, accessing different cognitive domains in the following areas: attention and concentration, executive functions, memory, language, visuoconstructive skills, conceptualization, calculation and guidance. The total MoCA score is 30 points, with a score of 26 or more considered normal.
• 1.1 - Cognition - Dot-couting — Change from baseline at 3 months
  This task assesses sustained attention and working memory. The participant is presented with various screens containing different sets of shapes and is instructed to count a specific type. In addition to counting, the participant must remember the totals across multiple trials, which requires continuous focus and short-term retention. This task is sensitive to impairments in attentional and memory systems, often affected in neurological conditions.
• 1.2 - Cognition - Set-shifting — Change from baseline at 3 months
  This task aims to assess executive shifting, one of the cognitive functions involved in mental flexibility. The stimuli consist of geometric shapes (rectangle or triangle) in different colors (red or blue). During the test, the participant sees a cue word displayed in the center of the screen-either "color" or "shape". Above this cue, a target stimulus (a colored shape) appears. In the lower left and right corners of the screen, two response options are shown, each representing a different combination of shape and color. The participant must select the correct option based on the instruction word shown-i.e., they must match the target either by color or by shape, alternating between these classification rules depending on the cue presented on each trial.
• 1.3 - Cognition - Flanker — Change from baseline at 3 months
  The Flanker Task is used to assess selective attention and inhibitory control. The participant sees a row of five arrows and must quickly indicate the direction of the central arrow (the target), while ignoring the surrounding arrows (flankers). These flankers may be congruent (pointing in the same direction) or incongruent (pointing in the opposite direction). The task measures the individual's ability to suppress irrelevant stimuli and respond accurately to the target, making it a valuable tool for detecting deficits in executive control.
• 1.4 - Cognition - Animal Fluency — Change from baseline at 3 months
  In this task, the participant is asked to name as many animals as possible in one minute. It evaluates semantic verbal fluency and is highly sensitive to early dysfunction in brain regions associated with language, particularly in the frontotemporal areas.
• 1.5 - Cognition - MoCA — Change from baseline at 3 months
  The MoCA (Montreal Cognitive Assessment) was used to assess global cognition. In Brazil, the interpretation of MoCA scores varies according to educational level and group differences (Cesar et al., 2019). The MoCA cutoff score to differentiate cognitively unimpaired (CU) from people with dementia is 15. To distinguish cognitively unimpaired (CU) from people mild cognitive impairment (MCI), the cutoff score is 19. Furthermore, the MoCA cutoff score for identifying MCI varies according to individuals' educational levels, reflecting the importance of tailoring assessments to educational contexts. For individuals with no formal education, the cutoff score is 11.5. Those with 1 to 4 years of education have a cutoff score of 18. Individuals with 5 to 8 years of education have a cutoff score of 19.5, as do those with 9 to 11 years of schooling. Finally, for individuals with 12 or more years of education, the cutoff score is 22. These values underscore the need to consider educational context
• Language — Change from baseline at 3 months
  The Toolkit to Examine Lifelike Language (TELL) will be used in this study to assess elements of language and speech. This application enables the recording, storage, and encryption of participants' oral productions. Speech samples will be recorded in Wave format (.wav) with an optimal sampling rate of 44.1 kHz and bit depth of 24 bits. Transcriptions will be performed automatically via Whisper, integrated within the TELL platform, and manually reviewed according to standard criteria established in previous studies (Steeb et al., 2018). Both audio files and transcriptions will undergo pre-processing using validated pipelines, allowing for the extraction of linguistic and acoustic features. These automated methods will be employed to identify distinct speech patterns, as described by Garcia et al. (2022). In addition, the tools used in the study offer potential to assess and monitor disease progression and treatment effectiveness in relation to verbal communication (Garcia et al, 2016)

Trial sites (2)

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