Effects of Different Physical Therapies and Dance in People With Parkinson's Disease

Study Overview
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Brief Summary
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The aim of study is to analyze the effects of different physical therapies (Aquatic Jogging, Neurofunctional Physiotherapy, Pilates Training and Nordic Walking) and Dance and compare with unsupervised home exercises in the clinical-functional parameters, postural balance, muscular echographic quality, pendulum gait mechanism, and serum levels of BDNF in people with Parkinson's disease with camptocormia or Pisa Syndrome.

Detailed Description
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Objective: Analyze the effects of different physical therapies (Aquatic Jogging, Neurofunctional Physiotherapy, Pilates Training and Nordic Walking) and Dance and compare with unsupervised home exercises in the clinical-functional parameters, postural balance, muscular echographic quality, pendulum gait mechanism, and serum levels of brain-derived neurotrophic factor (BDNF) in people with Parkinson's disease with camptocormia or Pisa Syndrome. Experimental Design: Randomized controlled clinical trial with translational study characteristics. Search Location: Exercise Research Laboratory at the School of Physical Education, Physiotherapy and Dance, Federal University of Rio Grande do Sul, and in the Movement Disorders Outpatient Clinic of the Hospital of Clinicals of Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil. Participants: 100 patients from the Unified Health System (UHS) of both sexes, from 50 to 80 years old, diagnosed with idiopathic PD, sedentary. Interventions: In this research, four groups of patients with PD will receive intervention during 4 months of different physical therapy programs (Nordic walking, aquatic jogging and supervised neurofunctional physiotherapy) and dance; and a control group, who will receive telephone guidance for performing home-based exercises. The training programs will have a duration of 4 months and will be periodized so that the duration of the sessions is matched between them. The intensity of the interval training will be manipulated by the subjective effort scale (Borg) and by the heart rate, with predetermined series durations. All training programs will have a frequency of two sessions per week and a duration of 60 minutes. In order to evaluate the effects of the training, evaluations will be performed before and after the training period: 1) Basal (month 0): initial pre-training evaluation; 2) month 4: Evaluation 48h after the last training session. Outcomes: clinical-functional parameters, postural balance, muscular echographic quality, pendulum gait mechanism, and biochemistry. Data Analysis: Data will be described by average values and standard deviation values. The comparisons between and within groups will be performed using a Generalized Estimating Equations (GEE) analysis, adopting a level of significance (α) of 0.05. Expected Results: The intervention groups of the different physical therapies and dance are expected to be more effective in all outcomes analyzed, especially improving functional mobility when compared to the control group of unsupervised home exercises. In addition, it is expected that the results of the research will be expandable and the possibility of future developments in the scientific, technological, economic, social and environmental fields and that they will be implemented in the Unified Health System (UHS).

Official Title
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Effects of Different Physical Therapies and Dance on Clinical and Functional Parameters, Muscle Quality, Pendular Mechanism of the Gait and Brain-derived Neurotrophic Factor in People With Parkinson's Disease

Conditions
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Parkinson Disease, Parkinson Disease 10

Intervention / Treatment
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* Other: Nordic Walking
* Other: Jogging
* Other: Dance
* Other: Pilates Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Volunteers aged over 40 years both sexes clinical diagnosis of idiopathic PD PD staging between 1 and 4 in Hoehn and Yahr Scale (H&Y). Exclusion Criteria: performing recent surgeries, deep brain stimulation (DBS - Deep Brain Stimulations); severe heart diseases, uncontrolled hypertension, myocardial infarction within a period of less than one year, being a pacemaker; stroke or other associated neurological diseases; insanity; prostheses in the lower limbs; without ambulation conditions.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nordic Walking<br>The patient walk program consists of 3 moments: warm up, walk and stretch. They will do a brief free walking warm-up for 3 minutes in the Self-selected walking speed - SSWS (3 'SSWS), then walk according to the training cycle, the intensity will be between 60 to 80% of the Heart of Ratio reserve. In addition, the intensity of the classes will be measured in each phase by the Borg Scale of Perceived Exertion. | Other: Nordic Walking<br>* 24 sessions will be held twice a week, with each session taking an average of 60 minutes.<br>|
| Experimental: Jogging<br>This group will undergo 24 Dance sessions. Aquatic therapy patients will receive deep water running intervention with the use of flotation vests. The exercises will consist of: immersion, balance, strength, agility, and movement within the water. The intensity of the classes will be measured in each moment and by the Borg Scale of Perceived Exertion. | Other: Jogging<br>* 24 sessions will be held twice a week, with each session taking an average of 60 minutes.<br>|
| Experimental: Dance<br>This group will undergo 24 Dance sessions inspired by Forró dance rhythm and Samba dance rhythm. Classes will be divided into four stages: Joint warm up and stretching on the chairs; strengthening, balance and rhythm exercises with the support of the barre; exercises inspired by the Samba and Forró dance (Brazilian ballroom dance) basic steps; and Final cool down. The intensity of the classes will be measured according to the beats per minute (BPMs) of the songs used in each moment and by the Borg Scale of Perceived Exertion. | Other: Dance<br>* 24 sessions will be held twice a week, with each session taking an average of 60 minutes.<br>|
| Experimental: Pilates Training<br>Classes composed of three phases: Warming up, main part and back to calm. Warming up will begin with pre-Pilates training exercises for 5 minutes (eg. breathing exercises, hip joint mobilization, shoulder girdle, etc.), the main part of the lesson will be the Pilates training drill sequence for the beginner level that will be conducted for 50 minutes in which all exercises will be performed on the floor. The sequence of the eighteen exercises of the main part of the lesson is described in the table below. Back to Calm: will be carried out for 5 final minutes with standing exercises with the subject reclining on the wall to reconnect the subject with orthostatic posture. In the each of the phases of the lesson will be shown to the subject the table of BORG with the objective of measuring the intensity of perceived exertion, using the Borg Scale of Perceived Exertion. | Other: Pilates Training<br>* 24 sessions will be held twice a week, with each session taking an average of 60 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test Timed Up and Go | Test Timed Up and Go This teste evaluate the mobility functional in three meters of self-selected speed (TUGSS) or at forced speed (TUGFS). | Change from baseline at 12 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Locomotor Rehabilitation Index | The Locomotor Rehabilitation Index (LRI) is a method of determining how close is the self-selected walking speed compared to the Optimum Speed. The results is given in %, and when LRI value is closer to 100 %, it indicates that the participants are closer to their theoretical optimal walking speed. | Change from baseline at 12 weeks. | 
| Self-selected walking speed | SSWS This outcome will be measure in test of walking treadmill. | Change from baseline at 12 weeks. | 
| Optimal Walking Speed (OPT) | This outcome will be measure through of the registered image movement analysis using the three-dimensional motion analysis system (VICON) of the walking test on treadmill. | Change from baseline at 12 weeks. | 
| Quality of life (QoL): PDQ-39 | The quality of life will be measured by the Parkinson's Disease Questionnaire, with 39 questions (PDQ-39). PDQ-39 is a PD specific health status questionnaire comprising 39 items. Respondents are requested to affirm one of five ordered response categories according to how often, due to their PD, they have experienced the problem defined by each item. The total scores are ranging between 0 and 100 points, that a lower score represents a greater perception of quality of life. | Change from baseline at 12 weeks. | 
| Cognitive function - Montreal Cognitive Assessment | Montreal Cognitive Assessment (MoCA) is a brief screening tool for mild cognitive impairment. This evaluation accesses different cognitive domains and investigates the individual's abilities in the following areas: attention and concentration, executive functions, memory, language, visuoconstructive skills, conceptualization, calculation and orientation. The total score of the MoCA is 30 points, with a score of 26, or more, considered normal and less than 26 is considered cognitive impairment. | Change from baseline at 12 weeks. | 
| Cognitive function - Mini Mental State Examination | Mini-Mental State Examination (MMSE) is a screening tool, used to identify dementia, which provides information on different cognitive parameters, containing questions grouped into seven categories that assess specific cognitive functions: temporal orientation, spatial orientation, three word registration, attention and calculation, recall of three words, language and visual constructive ability. The MMSE score can range from zero to 30 points, in which a lower score indicates a higher degree of cognitive impairment. | Change from baseline at 12 weeks. | 
| Depressive symptoms | This outcome will be measure for the Geriatric Depression Scale - 15 item. The scale consists of 15 dichotomous questions in which participants are asked to answer yes or no in reference to how they felt over the past week (for instance, Do the pacient feel that their life is empty?, Do the patient feel that their situation is hopeless?). Scores range from 0 to 15 with higher scores indicating more depressive symptoms. | Change from baseline at 12 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mobility, Functionality, Movement disorders, Rehabilitation, Locomotion