Clinical trial NCT03860649: Effects of Different Physical Therapies and Dance in People With Parkinson's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Parkinson Disease 10
Keywords: Mobility
Functionality
Movement disorders
Rehabilitation
Locomotion
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Aline Nogueira Haas
name: Flávia Gomes Martinez
First posted: 2019-03-04
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Test Timed Up and Go
timeFrame: Change from baseline at 12 weeks.
Secondary outcomes:
measure: Locomotor Rehabilitation Index
timeFrame: Change from baseline at 12 weeks.
measure: Self-selected walking speed
timeFrame: Change from baseline at 12 weeks.
measure: Optimal Walking Speed (OPT)
timeFrame: Change from baseline at 12 weeks.
measure: Quality of life (QoL): PDQ-39
timeFrame: Change from baseline at 12 weeks.
measure: Cognitive function - Montreal Cognitive Assessment
timeFrame: Change from baseline at 12 weeks.
measure: Cognitive function - Mini Mental State Examination
timeFrame: Change from baseline at 12 weeks.
measure: Depressive symptoms
timeFrame: Change from baseline at 12 weeks.
Other outcomes:
measure: Motor symptoms
timeFrame: Change from baseline at 12 weeks.
measure: Freezing of Gait
timeFrame: Change from baseline at 12 weeks.
measure: Balance Static
timeFrame: Change from baseline at 12 weeks.
measure: Spatial Parameter - Stride length
timeFrame: Change from baseline at 12 weeks.
measure: Temporal Parameter - Swing time, contact time, time of balance
timeFrame: Change from baseline at 12 weeks.
measure: Anthropometric data - Body mass
timeFrame: Change from baseline at 12 weeks.
measure: Anthropometric data - Height
timeFrame: Change from baseline at 12 weeks.
measure: Anthropometric data - Circumference
timeFrame: Change from baseline at 12 weeks.
measure: Anthropometric data - Body Mass Index
timeFrame: Change from baseline at 12 weeks.
measure: Electromyographic Parameters
timeFrame: Change from baseline at 12 weeks.
measure: Parameters of Pendular Mechanism - Internal Work
timeFrame: Change from baseline at 12 weeks.
measure: Parameters of Pendular Mechanism: external work
timeFrame: Change from baseline at 12 weeks.
measure: Parameters of Pendular Mechanism: total mechanical work
timeFrame: Change from baseline at 12 weeks.
measure: Parameters of Pendular Mechanism: Recovery
timeFrame: Change from baseline at 12 weeks.
measure: Motor behavior by electromyographic activity
timeFrame: Change from baseline at 12 weeks.
measure: Muscular activation
timeFrame: Change from baseline at 12 weeks.
measure: Scapular and pelvis coordination parameters
timeFrame: Change from baseline at 12 weeks.
measure: Angular variables
timeFrame: Change from baseline at 12 weeks.
measure: Body Composition - Bone mineral density.
timeFrame: Change from baseline at 12 weeks.
measure: Psychological parameters - Profile of Mood State
timeFrame: Change from baseline at 12 weeks.
measure: Quality of sleep - The Pittsburgh Sleep Quality Index
timeFrame: Change from baseline at 12 weeks.
measure: Nominal verbal fluency
timeFrame: Change from baseline at 12 weeks.
Locations:
city: Porto Alegre
country: Brazil
facility: Federal University of Rio Grande do Sul
state: Rio Grande Do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Leonardo Alexandre Peyré-Tartaruga, PhD
role: STUDY_DIRECTOR
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