Effects of Land and Water Physiotherapy on Motor Function in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
Parkinson's disease patients have characteristic postural changes in upper limbs, lower limbs and trunk. The presence of kyphosis is observed as the most common postural deformity. The aim of this study is to verify the effect of dry soil therapy and shallow water therapy on muscle function in individuals with Parkinson's disease? Regarding the benefits, is there a difference between the therapies?

Detailed Description
-----------------
Parkinson's disease (PD) is a chronic progressive neurological disorder that involves motor and non-motor symptoms that commonly include bradykinesia, rigidity, tremor and postural instability and culminates in functional decline and disability. Postural instability is due to postural changes that are commonly found in these individuals. Muscular disorders characterized by the inability to generate adequate synergy patterns may be responsible for postural instability, leading to postural changes in the sagittal plane, usually with the installation of hyperkyphosis. Exercise is increasingly being recognized as an effective and highly promising non-pharmacological intervention for improving muscle strength in PD. Typical physiotherapy treatment on the ground includes strength training, gait and balance training and has numerous benefits in reducing the motor symptoms of PD. Interventions such as aquatic physical therapy have a growing body of evidence to support the effectiveness of exercise in the PD population. Aquatic exercise has the intrinsic advantage of helping individuals shed their body weight, leading to greater effectiveness of the exercise itself. Knowing that muscle strength is associated with functional capacity and disease severity, physiotherapy becomes an important treatment resource with exercises to improve muscle strength and consequently reduce subsequent functional difficulties. However, due to the scattered evidence of physiotherapy in PD, there is not enough evidence to prescribe a defined rehabilitation program for strengthening trunk extensor musculature, although there is increasing evidence of the effectiveness of therapies on land or aquatic therapy, the evidence is insufficient to support or refute the effectiveness of one physiotherapeutic intervention over another. Therefore, the objective of this study is to investigate the effect of physiotherapy on land and physiotherapy in shallow water in relation to the composition and strength of the trunk extensor and flexor musculature of individuals with Parkinson's disease. A Randomized Clinical Trial will be conducted, in which individuals with a diagnosis of Parkinson's Disease, of the akinetic rigid type, with postural instability, classified from 1 to 3 by the Hoehn and Yahr Scale, aged between 60 and 75 years, and who sign the Free and Informed Consent Form. Individuals will be randomized into three treatment groups: physical therapy on land, aquatic physical therapy and power training. Evaluation will be carried out in two stages: pre-intervention and post-intervention. The evaluation will consist of an analysis of: Cognitive function of individuals with Parkinson's disease by the Mini Mental State Examination; Muscle strength of trunk flexors and extensors and knee extensors and flexors in individuals with Parkinson's disease using an isokinetic dynamometer (Cybex); Echogenicity and thickness of the quadriceps muscles in individuals with Parkinson's disease through ultrasonography; Body composition by DEXA; Balance and functional capacity of individuals with Parkinson's Disease through the Timed Up and Go Test - TUG; Motor function by the Unified PD Scale (UPDRS III); Assessment of strength and balance through the sit and stand test; Static and dynamic balance through the Berg Scale and Test of Romberg; Quality of life of individuals with Parkinson's Disease through the Parkinson Disease Questionnaire - PDQ39; Postural and gait analysis, by VICON; Flexibility of the posterior musculature of the lower limbs through the Bank of Wells; Treatment sessions will take place twice a week for 12 weeks and will last 60 minutes each, totaling 24 sessions. Functional capacity through the Vertical Jump - Jump with counter movement (CMJ).

Official Title
-----------------
Effects of Physical Therapy on Land and Aquatic Physical Therapy on the Motor Function of Individuals With Parkinson's Disease

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Other: Physiotherapy on the ground
* Other: Aquatic physiotherapy
* Other: Power training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with Parkinson's Disease and rated from 1 to 3 on the Hoehn and Yahr Scale; With akinetic rigid type PD; Aged between 50 and 85 years old; Who sign the Free and Informed Consent Term (TCLE). Exclusion Criteria: Parkinson's disease of the dominant tremor type; Previous associated neurological diseases; Severe heart diseases; Uncontrolled high blood pressure; Previous spine surgeries; Tumors or infection of the spine; Inflammatory diseases of the spine; Chlorine allergy; Aquaphobia; Achieve a minimum score of 24 points on the Mini Mental State Exam

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Individuals with Parkinson's Disease to perform physiotherapy on the ground.<br>The protocols will last for 12 weeks, with a frequency of 2 times a week. | Other: Aquatic physiotherapy<br>* Aquatic physiotherapy will be performed in 12 weeks, twice a week, in shallow water. The exercises will be based on a protocol developed by the researchers. This protocol has 15 exercises, aimed at muscle function and extensor musculature. All exercises can be adapted according to the severity of the individual, as well as the progression of these exercises will be made according to the adaptation and ease of individuals throughout the intervention.<br>Other: Power training<br>* The individuals will be submitted to the same exercises as the therapy protocol on the ground, but with a focus on power training, with fewer repetitions of the exercises and greater speed of movement in the concentric phase of the movement. As with other therapies, participants will be accompanied by therapists in small activity groups.<br>|
| Active Comparator: Individuals with Parkinson's Disease to undergo aquatic physiotherapy<br>The protocols will last for 12 weeks, with a frequency of 2 times a week. | Other: Physiotherapy on the ground<br>* Physical therapy will be performed on the ground, in 12 weeks, twice a week. The exercises will be based on a protocol developed by the researchers. This protocol has 15 exercises, aimed at muscle function and extensor musculature. All exercises can be adapted according to the severity of the individual, as well as the progression of these exercises will be made according to the adaptation and ease of individuals throughout the intervention.<br>Other: Power training<br>* The individuals will be submitted to the same exercises as the therapy protocol on the ground, but with a focus on power training, with fewer repetitions of the exercises and greater speed of movement in the concentric phase of the movement. As with other therapies, participants will be accompanied by therapists in small activity groups.<br>|
| Active Comparator: Individuals with Parkinson's Disease to perform physiotherapy on the ground with power training.<br>The protocols will last for 12 weeks, with a frequency of 2 times a week. | Other: Physiotherapy on the ground<br>* Physical therapy will be performed on the ground, in 12 weeks, twice a week. The exercises will be based on a protocol developed by the researchers. This protocol has 15 exercises, aimed at muscle function and extensor musculature. All exercises can be adapted according to the severity of the individual, as well as the progression of these exercises will be made according to the adaptation and ease of individuals throughout the intervention.<br>Other: Aquatic physiotherapy<br>* Aquatic physiotherapy will be performed in 12 weeks, twice a week, in shallow water. The exercises will be based on a protocol developed by the researchers. This protocol has 15 exercises, aimed at muscle function and extensor musculature. All exercises can be adapted according to the severity of the individual, as well as the progression of these exercises will be made according to the adaptation and ease of individuals throughout the intervention.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MDS UPDRS Motor Assessment | The third part of the revised version of the Unified Parkinson's Disease Scale (UPDRS) by the Movement Disorders Society (MDS) (Appendix 2) assesses signs, symptoms, and specific activities through self-report and observer observation. The MDS UPDRS III assesses motor function including speech, facial expression, stiffness, finger tapping (pinch), hand movements, hand pronation-supination movements, toe tapping, leg agility, standing chair, gait, freezing, postural stability, posture, overall spontaneity of movement (body bradykinesia), postural hand tremor, kinetic hand tremor, resting tremor amplitude, and resting tremor persistence. The cutoff points for classifying motor impairment as mild, moderate and severe are as follows: Mild/Moderate - 32/33, Moderate/Severe - 58/59 | 3 months | 
| Berg Scale and Romberg Test | The Berg Balance Scale (BBS), translated and validated into Brazilian Portuguese in 2004, was used to assess postural balance. The BBS, developed in 1992, consists of 14 common tasks involving static and dynamic balance. The tasks are evaluated through observation, presenting an ordinal scale of five alternatives, ranging from zero to four, totaling a maximum score of 56 points. The score decreases if the time to perform the task is not reached, or the individual needs supervision or external support to perform it. The Romberg test, on the other hand, consists of a clinical evaluation that reveals alterations in the patient's static balance, allowing the analysis of 3 neurophysiological bases that make balance possible: vestibular, visual and proprioceptive systems. This test exists to investigate disturbances that interfere with this task. A positive Romberg can be seen with loss of balance during the procedure. | 3 months | 
| Timed Up and Go (TUG) | The Timed Up and Go (TUG) test will also be used, which was developed to assess balance, risk of falls and functional capacity of elderly individuals, timing the time it takes the individual to leave the sitting position with the back supported on a chair, stand up, walk 3 meters to a marked point on the ground as fast as possible, turn around, return to the chair and sit down again, leaning against it. Performance is evaluated according to the time taken to perform the task. It takes approximately 1 to 2 minutes and only requires a chair approximately 46cm high and 65cm high armrest, a stopwatch and a 3 meter runner. The patient will perform the test a first time to understand the task and a second time for registration and evaluation. A time greater than 30 seconds to perform the task is indicative of the individual's functional dependence. | 3 months | 
| Dexa | Whole-body dual-energy X-ray absorptiometry (DEXA) is a sensitive and accurate method for quantifying body composition, including fat mass and lean body mass as a surrogate measure of skeletal muscle. Body composition will be estimated by dual-energy X-ray absorptiometry. Prior to scanning, participants will be asked to remove all removable objects containing metal (i.e. jewelry, glasses, clothing with buttons and/or zippers). Scans will be performed with participants lying supine along the longitudinal axis of the centerline of the scanning table. The feet will be tied together to immobilize the legs, while the hands will be kept in a prone position within the scanning region. All exams will be performed by the same evaluator. DEXA results will include body composition parameters including fat free mass, body fat percentage, fat mass and bone mineral density (whole body, whole left femur and lumbar spine vertebrae). | 3 months | 
| Ultrasonography | Ultrasonography is a non-invasive method for assessing the thickness and echogenicity of skeletal muscle. The research subjects will be approved to evaluate the quadriceps femoris musculature through Ultrasonography Nemio XG (Toshiba, Japan) in B mode and a 3.75 MHz convex transducer. The transducer will be coated with a water-soluble transmission gel to provide acoustic contact without depressing the dermal surface. | 3 months | 
| Isokinetic dynamometer | The isokinetic dynamometer is considered the gold standard instrument for assessing muscle performance, whether to analyze the effectiveness of training, treatment or even to verify a person's muscle condition. The individuals will be submitted to an isokinetic muscular evaluation of the trunk extensor and flexor muscles and knee extensors performed in a Cybex Norm isokinetic dynamometer (Cybex Inc., Ronkonkoma, NY, USA). | 3 months | 
| Parkinson's Disease Questionnaire (PDQ-39) | The PDQ-39 will be applied to assess the patient's perception of quality of life, participation and restrictions resulting from the disease. The PDQ-39 is the most used disease-specific quality of life assessment tool in PD. The questionnaire consists of 39 questions covering the themes: mobility, activities of daily living, emotional well-being, social support, bodily discomfort, stigma, cognition and communication. The individual identifies how often in the last month he found himself in the situations mentioned. The options are never (0 points), rarely (1 point), sometimes (2 points), often (3 points), and always (4 points). Between 0 and 100, the lowest score corresponds to the highest quality of life. | 3 months | 
| Bank of Wells | Also known as sit and reach, this instrument allows you to assess the flexibility and range of stretching of the back of the trunk and legs. The evaluated person must flex the trunk over the hip, pushing the wooden stick on the box that has a millimeter measuring tape. The total distance achieved represents the final score, and 3 attempts will be made. | 3 months | 
| Vertical Jump - Counter Motion Jump (CMJ) | The CMJ jump will be performed on a force platform. The signal capture will be performed at a frequency of 1000 Hz and the force platform will be calibrated before all tests according to the manufacturer's instructions. The jumps will start from the static standing position, then they must perform a counter movement (down phase) followed by a quick and vigorous extension of the lower limb (up phase). Participants will be instructed to keep the torso as vertical as possible, with hands on hips, and with the knee angle at approximately 90° at the end of the descent phase of the movement. The jump technique will be analyzed by the evaluator, and 3-4 valid CMJ jumps (according to the adopted validation criteria) will be recorded for later analysis. For the analysis procedures, Matlab software will be used, the data obtained from the jumps will be the jump height in cm, average power in W and peak power in W. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson Disease, Physical Therapy Modalities, Muscle Strength, Aquatic Therapy