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

NCT06967493 | Recruiting

• 1 other identifier: CAAE: 75675023.9.0000.5327
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Parkinson Disease

Keywords

Dance; Cognition; Non-motor symptoms

Outcome Measures

Primary Outcomes (7)

• Cognition

  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.

  Change from baseline at 3 months

• 1.1 - Cognition - Dot-couting

  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.

  Change from baseline at 3 months

• 1.2 - Cognition - Set-shifting

  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.

  Change from baseline at 3 months

• 1.3 - Cognition - Flanker

  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.

  Change from baseline at 3 months

• 1.4 - Cognition - Animal Fluency

  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.

  Change from baseline at 3 months

• 1.5 - Cognition - MoCA

  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

  Change from baseline at 3 months

• Language

  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)

  Change from baseline at 3 months

Secondary Outcomes (7)

• Anxiety symptoms

  Change from baseline at 3 months

• Depressive symptoms

  Change from baseline at 3 months

• Quality of life symptoms

  Change from baseline at 3 months

• Levels of Hope

  Change from baseline at 3 months

• Functional Mobility

  Change from baseline at 3 months

Other Outcomes (2)

• PD motor symptoms

  Change from baseline at 3 months

• Experience with Dance

  baseline

Study Arms (2)

Dance

EXPERIMENTAL

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.

Behavioral: Amazonian Dance

Control Group

ACTIVE COMPARATOR

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).

Behavioral: Nordic Walking

Interventions

Amazonian Dance BEHAVIORAL

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.

Dance

Nordic Walking BEHAVIORAL

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.

Control Group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead
• Universidade Federal do Para: collaborator

Study Sites (2)

Universidade Federal do Pará

Castanhal, Pennsylvania, 68746-630, Brazil

RECRUITING

Universidade Federal do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90690-200, Brazil

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Nordic Walking

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Walking; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Central Study Contacts

Aline Nogueira Haas, PhD

CONTACT

+5551999633496; alinehaas02@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: May 13, 2025
• Study Start: August 4, 2025
• Primary Completion: November 26, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)