Clinical trial NCT03235453: Dance for People With Parkinson's Disease
Official title: Influence of Binary and Quaternary Rhythm in Motor Symptoms, Sleep, Failure and Quality of Living in People With Parkinson Disease: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Quality of Life
Sleep Disorder
Gait Disorders, Neurologic
Mobility Limitation
Keywords: Parkinson
Quality of Life
Sleep Disorder
Gait Disorders
Mobility
Lead sponsor: Laboratório de Pesquisa em Lazer e Atividade Física
Sponsor class: OTHER
First posted: 2017-08-01
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Randomized clinical trial, two arm study (group 1 - Binary Rhythm; group 2 - Quaternary Rhythm
Primary purpose: TREATMENT

Brief summary: The randomized clinical trial will aim to analyze the influence of binary and quaternary rhythm through a protocol on motor symptoms, sleep, fatigue and quality of life in individuals with Parkinson's disease. The study design with a randomized clinical trial, including individuals diagnosed with Parkinson's Disease, will be divided into two groups: 1) Control group 2) Experimental group. Cognition, balance, gait freezing, functional mobility, quality of life, sleep, daytime sleepiness and fatigue will be evaluated. Through the application of binary and quaternary rhythm protocol for a period of 12 weeks. First, the descriptive statistics (mean, standard deviation and percentage) will be used to know the data, then the normality calculation using the Kolmogorov Smirnov test will be used to choose the statistical tests. All information will be collected before and after the intervention period. For statistical analysis, use the SPSS statistical package, version 20.0. (Kolmogorov-Smirnov or Shapiro-Wilk test) for the selection of statistical tests.

Detailed description: The project includes two protocols: (1) Dance binary rhythm and (2) Dance quaternary rhythm. Each session will last 45 minutes for each modality, twice a week, over a period of 12 weeks. Blood pressure (BP) and heart rate will be seen at the beginning and end of each class. In addition to the Effort Perception Scale - Borg Scale used to assess the intensity and / or discomfort during physical activity practice in both protocols. In both modalities of intervention, the evolution of the movements will always respect the limit of each patient. The binary rhythm protocol will be performed through forró, meringue and bolero rhythms, this type of methodology was selected, because it is a stimulating rhythm that brings harmony of the movements, being able to be associated to improvements in the mobility, balance and quality of life of the individuals who Practice it, benefiting patients directly.

The binary protocol classes will be divided into: heating (10 minutes) focused on dance styles that contemplate the binary rhythm, with walks in the marking of the musical rhythm, muscular release, breathing, movements for upper and lower limbs, always working musicality . The main part (30 minutes) will be divided into two moments, first individually so that the teacher can show and teach in a clear way the steps that will be performed then the participants will form pairs and perform the steps that were taught them. Every 5 minutes the participants will change their pair, so that everyone can have the experience of dancing with their colleagues. And to finish it will be carried out a calm return (5 minutes) to provide muscular relaxation with stretches and massages.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of PD following the criteria of the brain bank of London.
* Individuals of both sexes, aged 25 years or older.
* With stable doses of the medication, in the "On" phase of the medication.

Exclusion Criteria:

* Individuals who do not complete all study steps.
* That they are not stable in doses of medication.

Primary outcomes:
measure: Balance
timeFrame: 10 minutes
measure: Gait
timeFrame: 10 minutes
measure: Mobility
timeFrame: 5 minutes
Secondary outcomes:
measure: Quality of life
timeFrame: 5 minutes
measure: Sleep
timeFrame: 5 minutes
measure: Daytime sleepiness
timeFrame: 5 minutes
measure: Fatigue
timeFrame: 5 minutes
Other outcomes:
Locations:
Study officials:
affiliation: University of the State of Santa Catarina
name: Jéssica Moratelli
role: PRINCIPAL_INVESTIGATOR
affiliation: University of the State of Santa Catarina
name: Adriana CA Guimarães, PhD
role: STUDY_DIRECTOR
affiliation: University of the State of Santa Catarina
name: Kettlyn Hames
role: PRINCIPAL_INVESTIGATOR
References: