Authors
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Universidade do Estado de Santa Catarina -More
Category
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Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
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2024
INTERVENTION: This is a three‐arm, open, randomized controlled clinical study. The study will consist of two experimental groups (interventions with Free Dance and Hatha Yoga) and a control group (routine activity). An estimated 11 participants in each group, totaling 33 participants, all diagnosed with Parkinson's disease. The free dance and hatha yoga interventions will last 60 minutes, twice a week over 12 weeks. Interventions will occur with patients in the medication ON state (when symptoms of Parkinson's disease are controlled by Levodopa) CONDITION: C10.228 Parkinson's Disease PRIMARY OUTCOME: Using the Parkinson's Disease questionnaire method (PDQ 39), it is expected to evaluate the quality of life of people with Parkinson's after interventions. This instrument provides information on the impact of the disease in eight dimensions (mobility, activities of daily living, emotions, stigma, social, cognition, communication and body pain). There are 39 items ranging from 0 (never) to 4 (always) and a maximum score of 100 points. The higher the value, the worse the quality of life (Jenkinson et al., 1997) SECONDARY OUTCOME: By presenting the outcome using the Rosenberg Self‐Esteem Scale (RSS), it is expected to verify the self‐esteem aspect. One‐dimensional measure consisting of ten statements and related to a set of feelings of self‐esteem and self‐acceptance that determine global self‐esteem. 50% of the items are stated positively and 50% negatively By using the goniometer and presenting this result, we hope to verify whether the range of movement of the shoulders improved after the interventions.To assess shoulder flexion, the person will be in the supine position, placing the fixed arm of the goniometer in the mid‐axillary line of the trunk, pointing towards the greater trochanter of the femur, the movable one on the lateral surface of the body of the humerus facing the lateral epicondyle and the axis close to the acromion. During abduction, the patient will be assessed standing with one of the arms extended, with the goniometer fixed arm on the posterior axillary line of the trunk, the movable arm on the posterior surface of the arm and the axis close to the acromion. During extension, you will also be standing with one of your arms extended, with the fixed arm of the goniometer in the mid‐axillary line pointing towards the greater trochanter of the femur, the mobile placed on the lateral surface of the body of the humerus facing the lateral epicondyle and the lateral axis. lateral side of the glenohumeral joint. According to the Goniometry Manual, Measurement of Joint Angles (2016) Cardiorespiratory fitness: The six‐minute walk test (6MWT) will be used to analyze cardiorespiratory fitness, as it is a safe instrument for submaximal evaluation of the cardiorespiratory system, and there is no need for medical supervision. The materials involved will be a stopwatch, a blood pressure meter and an oximeter, and the distance covered will be calculated in meters, as well as measuring heart rate, blood pressure and oxygen saturation at the pre‐ and post‐test moments. To analyze the distance traveled variable, the delta percentage (?%) will be used to calculate the variations (Crapo, 2002; Holland et al., 2014) Depressive symptoms will be analyzed using the Beck Depression Inventory (BDI). It contains 21 objective multiple‐choice questions related to depressive symptoms such as lack of hope, irritation, cognitions, guilt and feelings of punishment, as well as physical symptoms such as fatigue, weight loss and sexual interest. The highest score is 63, which indicates a high degree of depressive symptoms, and the lowest is zero, which corresponds to the absence of depressive symptoms (Beck et al., 1996) The Quality of Life of Fecal Incontinence (QLFI) method seeks to verify the improvement of these parameters after interventions. Consists of 29 questions that assess this aspect from the perspective of quality of life. The questions are divided into 4 domains: lifestyle, behavior, depression and embarrassment. The score for each item is given as a value from 1 to 4, with the exception of questions 1 (values from 1 to 5) and 4 (values from 1 to 6). To calculate the total score for each domain, it is necessary to calculate the average of its items, with the total score being equivalent to 5 (Rockwood et al., 2000) Through Mini BESTest, results on balance changes after interventions will be provided. 14‐item test covering the topics of dynamic balance (anticipated transitions), postural responses, sensory orientation, and dynamic gait Using the Beck Anxiety Inventory (BAI), the results of the anxiety aspect will be verified. This test consists of 21 self‐reported questions that address the symptoms of anxiety in somatic, affective and cognitive signs. Each question has four answers with scores ranging from 0 to 3 (none; mild; moderate; severe) (Beck et al., 1988) Using the Herth Hope Scale (HHS), improvement in the hope aspect will be verified. The questionnaire has 12 items written in an affirmative manner where the items are graded using a 4‐point Likert scale. The total score varies from 12 to 48, with the higher the score, the higher the level of hope (Sartore; Grossi, 2008) Using the International Consultation on Incontinence Questionnaire ‐ Short Form (ICIQ‐SF), will be analyzed the urinary incontinence. It consists of four questions. The frequency, severity and impact of urinary incontinence. Analysis of eight items related to causes or situations of urinary incontinence experienced by the respondents and the general score is obtained by adding the scores for questions 3, 4 and 5. The score varies from 0 to 100; the higher the score obtained, the worse the quality of life related to that domain (Caetano et al., 2009) Using the Montreal Cognitive Assessment (MoCA) screening tool, eight cognitive domains will be assessed. Executive function; visuospatial ability; memory; attention; concentration and working memory; language, temporal and spatial orientation. Cognitive Standard Screening Instrument for Clinical Trials Related to Parkinson's Disease (Almeida et al., 2019b) Using the Unified Parkinson's Disease Rating Scale (UPDRS), it is expected to analyze general symptoms. The UPDRS evaluates several aspects of Parkinson's disease. Considered the gold standard assessment method and frequently used for clinical and research purposes. Consisting of 42 questions and divided into four parts: 1‐ Mental state, behavior and emotional state; 2‐ Activities of daily living; 3‐ Motor exploration and 4‐ Therapy complications. The score on this scale varies between 0 and 199, with a lower score being an indicator of less severity and a higher score being an indicator of greater symptom severity (“The Unified Parkinson’s Disease Rating Scale (UPDRS): Status and recommendations”, 2003) With the use of the goniometer and presentation of this result, it is expected to verify whether the range of hip movement, assessed in the extension and flexion movement, improved after the interventions.To evaluate the hip flexion movement, the person will lie in the supine position, with the hip flexed and one of the knees flexed, placing the fixed arm of the goniometer on the axillary line of the trunk and the mobile arm parallel to the lateral surface of the thigh, towards the femoral lateral condyle and the axis approximately at the level of the greater trochanter. Subsequently, the hip flexion position will be maintained, with the knee extended to perform the same measurement. Hip extension will also be assessed lying down, but in the prone position, with one of the legs extended, placing the fixed arm of the goniometer on the mid‐axillary line of the trunk, the movable one on the side of the thigh towards the lateral condyle of the femur and the axis approximately at the level of the greater trochanter. According to the Goniometry Manual Measuring Joint Angles (2016) INCLUSION CRITERIA: Clinical diagnosis confirmed by a neurologist following the Movement Disorder Society criteria; both sexes; residents of Florianópolis and São José; on stable doses of medication for the last four weeks; on ON medication; aged 45 years or over; not practicing physical exercise in the month prior to data collection; classified in stages 1 to 4 of PD by the Hoehn & Yahr Disability Scale
Epistemonikos ID: ebac6f89e7014ac68934f8deb2cf4d01479b66be
First added on: Aug 28, 2024