About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Recent surgeries,
Deep brain stimulation (DBS);
Other associated neurological diseases or chronic diseases
Fitted with a pacemaker;
Trial design
Parallel
Treatments tested in this trial
Amazonian Dance
BehavioralDance 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
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Secondary outcomes
Anxiety symptoms
Anxiety disorders will be assessed using the Parkinson Anxiety Scale (PAS), an instrument specifically developed to assess anxiety in PwPD (Leentjens et al., 2014). This scale consists of 12 questions, each of which can be scored from zero (0) to four (4), totalling a maximum score of 48 points. It is divided into the persistent anxiety subscale (AF; 1st to 5th questions), which measures generalized anxiety disorders; the episodic anxiety subscale (EA; 6th to 9th questions), which assesses panic disorder; and the avoidance behaviour subscale (AB; 10th to 12th questions), which assesses anxious symptoms of agoraphobia and social phobia.
Depressive symptoms
For the evaluation of depressive symptoms, the Geriatric Depressive Symptoms (GDS-15) will be used, which is a scale widely used and validated as a diagnostic tool for depression in the elderly, classified into mild, moderate and severe levels. It is a scale for assessing depressive symptoms, self-assessed, consisting of 15 questions, in which the result of five or more points is indicative of a probable depressive episode. (Paradela et al., 2005).
Quality of life symptoms
Quality of life will be measured by applying the Parkinson's Disease Questionnaire - 39 (PDQ-39), proposed and validated by Peto et al. (1995). The PDQ-39 comprises eight domains: mobility, daily life activities, emotional well- being, stigma, social support, cognition, communication, and bodily discomfort. Each item can be answered according to five predetermined answers: never; rarely; sometimes; often; always. The score of each item ranges from 0 to 4 points, and the total score varies from 0 to 100 points, where the lowest scores reflect a higher quality of life (Marinus et al., 2002; Lana et al., 2007).
Levels of Hope
To assess the levels of hope, the Herth Hope Scale will be used, which has 12 affirmatively written items where the items are graded on a 4-point Likert-type scale, ranging from completely agree to completely disagree, where 1 indicates completely disagree and 4 indicates completely agree. The total score ranges from 12 to 48 and the higher the score, the higher the level of hope (Sartore \& Grossi, 2008).
Other outcomes
PD motor symptoms
Part III of the MDS-UPDRS (Movement Disorder Society - Unified Parkinson's Disease Rating Scale) will be used in this study to assess participants' motor impairment. This section includes 18 items that evaluate speech, facial expression, resting and postural tremors, rigidity, hand and leg agility, posture, gait, balance, and dyskinesias. Each item is scored from 0 to 4, with a total score ranging from 0 (normal function) to 56 (greater motor impairment) (Goetz et al., 2021; Mello \& Botelho, 2010).
Experience with Dance
The Goldsmith's Dance Sophistication Index (Gold-DSI) is used to assess the participants' level of dance experience. Twenty items assess experience in dance participation along four subscales: body awareness (six items), social dancing (six items), urge to dance (five items), and dance training (three items). The general factor dance participation comprises all 20 items from the four subscales. The mean of range values (i.e., 1 to 7) reflects the result of each subscale or general factor, with higher scores (i.e., those near to 7) indicating higher dance sophistication. A further six items measure experience in watching dance. This questionnaire provides a brief, standardized, and continuous evaluation of doing, watching, and knowing about dance (Rose, Müllensiefen, Lovatt \& Orgs, 2022).
Sponsors and contacts
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Federal University of Rio Grande do Sul
Lead sponsor
Universidade Federal do Para
Collaborator