<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03235453</url>
  </required_header>
  <id_info>
    <org_study_id>71690317700000118</org_study_id>
    <nct_id>NCT03235453</nct_id>
  </id_info>
  <brief_title>Dance for People With Parkinson's Disease</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laboratório de Pesquisa em Lazer e Atividade Física</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Laboratório de Pesquisa em Lazer e Atividade Física</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The randomized clinical trial will aim to analyze the influence of binary and quaternary&#xD;
      rhythm through a protocol on motor symptoms, sleep, fatigue and quality of life in&#xD;
      individuals with Parkinson's disease. The study design with a randomized clinical trial,&#xD;
      including individuals diagnosed with Parkinson's Disease, will be divided into two groups: 1)&#xD;
      Control group 2) Experimental group. Cognition, balance, gait freezing, functional mobility,&#xD;
      quality of life, sleep, daytime sleepiness and fatigue will be evaluated. Through the&#xD;
      application of binary and quaternary rhythm protocol for a period of 12 weeks. First, the&#xD;
      descriptive statistics (mean, standard deviation and percentage) will be used to know the&#xD;
      data, then the normality calculation using the Kolmogorov Smirnov test will be used to choose&#xD;
      the statistical tests. All information will be collected before and after the intervention&#xD;
      period. For statistical analysis, use the SPSS statistical package, version 20.0.&#xD;
      (Kolmogorov-Smirnov or Shapiro-Wilk test) for the selection of statistical tests.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The project includes two protocols: (1) Dance binary rhythm and (2) Dance quaternary rhythm.&#xD;
      Each session will last 45 minutes for each modality, twice a week, over a period of 12 weeks.&#xD;
      Blood pressure (BP) and heart rate will be seen at the beginning and end of each class. In&#xD;
      addition to the Effort Perception Scale - Borg Scale used to assess the intensity and / or&#xD;
      discomfort during physical activity practice in both protocols. In both modalities of&#xD;
      intervention, the evolution of the movements will always respect the limit of each patient.&#xD;
      The binary rhythm protocol will be performed through forró, meringue and bolero rhythms, this&#xD;
      type of methodology was selected, because it is a stimulating rhythm that brings harmony of&#xD;
      the movements, being able to be associated to improvements in the mobility, balance and&#xD;
      quality of life of the individuals who Practice it, benefiting patients directly.&#xD;
&#xD;
      The binary protocol classes will be divided into: heating (10 minutes) focused on dance&#xD;
      styles that contemplate the binary rhythm, with walks in the marking of the musical rhythm,&#xD;
      muscular release, breathing, movements for upper and lower limbs, always working musicality .&#xD;
      The main part (30 minutes) will be divided into two moments, first individually so that the&#xD;
      teacher can show and teach in a clear way the steps that will be performed then the&#xD;
      participants will form pairs and perform the steps that were taught them. Every 5 minutes the&#xD;
      participants will change their pair, so that everyone can have the experience of dancing with&#xD;
      their colleagues. And to finish it will be carried out a calm return (5 minutes) to provide&#xD;
      muscular relaxation with stretches and massages.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 30, 2017</start_date>
  <completion_date type="Anticipated">December 20, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <intervention_model_description>Randomized clinical trial, two arm study (group 1 - Binary Rhythm; group 2 - Quaternary Rhythm</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Balance</measure>
    <time_frame>10 minutes</time_frame>
    <description>The Mini-BESTest test is a 14-item test that focuses on dynamic balance, specifically anticipated transitions, postural responses, sensory orientation, and dynamic gait. Each item is scored from (0-2); A score of 0 indicates that a person is unable to perform the task while a score of 2 is normal.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gait</measure>
    <time_frame>10 minutes</time_frame>
    <description>Freezing of Gait - FOG-Q - The score for each item ranges from zero to four, with higher scores indicating more severe freezing episodes. It presents a total score of 24, and the highest score represents a severe gait impairment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mobility</measure>
    <time_frame>5 minutes</time_frame>
    <description>Timed Up &amp; Go (TUG), The TUG measures the time it takes an individual to perform some functional maneuvers, such as getting up, walking, taking a walk, and sitting down.&#xD;
A) less than 20 seconds to perform, corresponds to low risk for falls. B) from 20 to 29 seconds, at medium risk for falls. C) 30 seconds or more at high risk for falls</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>5 minutes</time_frame>
    <description>The Parkinson's Disease Questionnaire - PDQ-39 Is a specific scale of evaluation of quality of life in PD, comprises 39 items that can be answered with five different response options: &quot;never&quot;; &quot;On occasion&quot;; &quot;sometimes&quot;; &quot;often&quot;; &quot;Always&quot; or &quot;impossible for me&quot;. The scores on each item range from 0 (never) to 4 (always or impossible for me).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep</measure>
    <time_frame>5 minutes</time_frame>
    <description>Parkinson's Sleep Scale (PDSS)- Addresses 15 symptoms associated with sleep disorders.The maximum score for PDSS is 150 (patient is free of all symptoms)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daytime sleepiness</measure>
    <time_frame>5 minutes</time_frame>
    <description>The Epworth Sleepiness Scale It is a self-administered questionnaire that evaluates the probability of falling asleep in eight situations involving daily activities, The overall score ranges from 0 to 24, with scores above 10 suggesting the diagnosis of excessive daytime sleepiness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>5 minutes</time_frame>
    <description>Fatigue Severity Scale: an instrument for evaluating the physical aspects of fatigue and its impact on the daily function of the patient. The FSS total score represents the average score of the nine articles ranging from 1 to 7, in which the higher scores indicate more severe fatigue</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Parkinson Disease</condition>
  <condition>Quality of Life</condition>
  <condition>Sleep Disorder</condition>
  <condition>Gait Disorders, Neurologic</condition>
  <condition>Mobility Limitation</condition>
  <arm_group>
    <arm_group_label>Binary rhythm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental: binary rhythm The randomized group for binary-rhythm intervention will receive a 12-week intervention with dance lessons. Classes will be divided into: Heating and stretching (5 minutes), main part (binary) (35 minutes) and relaxation (5 minutes).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Quaternary rhythm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The randomized group for the quaternary rhythm intervention will receive a 12-week intervention with dance classes. Classes will be divided into: Heating and stretching (5 minutes), main part (quaternary rhythm) (35 minutes) and relaxation (5 minutes).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Binary rhythm</intervention_name>
    <description>The binary rhythm intervention will be performed using the dance modalities, Forró, Merengue and Bolero. It will occur twice a week for 12 weeks with 45 minutes of sitting.</description>
    <arm_group_label>Binary rhythm</arm_group_label>
    <other_name>Dance</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quaternary rhythm</intervention_name>
    <description>The quaternary rhythm intervention will be performed using the modalities of dance, Tango, Salsa, Zouk. It will occur twice a week for 12 weeks with 45 minutes of sitting.</description>
    <arm_group_label>Quaternary rhythm</arm_group_label>
    <other_name>Dance</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of PD following the criteria of the brain bank of London.&#xD;
&#xD;
          -  Individuals of both sexes, aged 25 years or older.&#xD;
&#xD;
          -  With stable doses of the medication, in the &quot;On&quot; phase of the medication.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who do not complete all study steps.&#xD;
&#xD;
          -  That they are not stable in doses of medication.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jéssica Moratelli</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of the State of Santa Catarina</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Adriana CA Guimarães, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of the State of Santa Catarina</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kettlyn Hames</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of the State of Santa Catarina</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jéssica Moratelli</last_name>
    <phone>55 48 996153470</phone>
    <email>jessica.moratelli@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Adriana CA Guimarães, PhD</last_name>
    <phone>55 48 999811607</phone>
    <email>nanaguim@terra.com.br</email>
  </overall_contact_backup>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>August 2, 2017</last_update_submitted>
  <last_update_submitted_qc>August 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parkinson</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Sleep Disorder</keyword>
  <keyword>Gait Disorders</keyword>
  <keyword>Mobility</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Sleep Wake Disorders</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
    <mesh_term>Nervous System Diseases</mesh_term>
    <mesh_term>Gait Disorders, Neurologic</mesh_term>
    <mesh_term>Mobility Limitation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03235453
org study id: 71690317700000118
nct id: NCT03235453
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: Randomized clinical trial, two arm study (group 1 - Binary Rhythm; group 2 - Quaternary Rhythm
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Balance
time frame: 10 minutes
description: The Mini-BESTest test is a 14-item test that focuses on dynamic balance, specifically anticipated transitions, postural responses, sensory orientation, and dynamic gait. Each item is scored from (0-2); A score of 0 indicates that a person is unable to perform the task while a score of 2 is normal.
measure: Gait
time frame: 10 minutes
description: Freezing of Gait - FOG-Q - The score for each item ranges from zero to four, with higher scores indicating more severe freezing episodes. It presents a total score of 24, and the highest score represents a severe gait impairment
measure: Mobility
time frame: 5 minutes
description: Timed Up & Go (TUG), The TUG measures the time it takes an individual to perform some functional maneuvers, such as getting up, walking, taking a walk, and sitting down.
A) less than 20 seconds to perform, corresponds to low risk for falls. B) from 20 to 29 seconds, at medium risk for falls. C) 30 seconds or more at high risk for falls
measure: Quality of life
time frame: 5 minutes
description: The Parkinson's Disease Questionnaire - PDQ-39 Is a specific scale of evaluation of quality of life in PD, comprises 39 items that can be answered with five different response options: "never"; "On occasion"; "sometimes"; "often"; "Always" or "impossible for me". The scores on each item range from 0 (never) to 4 (always or impossible for me).
measure: Sleep
time frame: 5 minutes
description: Parkinson's Sleep Scale (PDSS)- Addresses 15 symptoms associated with sleep disorders.The maximum score for PDSS is 150 (patient is free of all symptoms)
measure: Daytime sleepiness
time frame: 5 minutes
description: The Epworth Sleepiness Scale It is a self-administered questionnaire that evaluates the probability of falling asleep in eight situations involving daily activities, The overall score ranges from 0 to 24, with scores above 10 suggesting the diagnosis of excessive daytime sleepiness
measure: Fatigue
time frame: 5 minutes
description: Fatigue Severity Scale: an instrument for evaluating the physical aspects of fatigue and its impact on the daily function of the patient. The FSS total score represents the average score of the nine articles ranging from 1 to 7, in which the higher scores indicate more severe fatigue
arm group label: Binary rhythm
arm group type: Experimental
description: Experimental: binary rhythm The randomized group for binary-rhythm intervention will receive a 12-week intervention with dance lessons. Classes will be divided into: Heating and stretching (5 minutes), main part (binary) (35 minutes) and relaxation (5 minutes).
arm group label: Quaternary rhythm
arm group type: Experimental
description: The randomized group for the quaternary rhythm intervention will receive a 12-week intervention with dance classes. Classes will be divided into: Heating and stretching (5 minutes), main part (quaternary rhythm) (35 minutes) and relaxation (5 minutes).
intervention type: Other
intervention name: Binary rhythm
description: The binary rhythm intervention will be performed using the dance modalities, Forró, Merengue and Bolero. It will occur twice a week for 12 weeks with 45 minutes of sitting.
arm group label: Binary rhythm
other name: Dance
intervention type: Other
intervention name: Quaternary rhythm
description: The quaternary rhythm intervention will be performed using the modalities of dance, Tango, Salsa, Zouk. It will occur twice a week for 12 weeks with 45 minutes of sitting.
arm group label: Quaternary rhythm
other name: Dance
criteria: 
gender: All
minimum age: 25 Years
maximum age: 100 Years
healthy volunteers: No
last name: Jéssica Moratelli
role: Principal Investigator
affiliation: University of the State of Santa Catarina
last name: Adriana CA Guimarães, PhD
role: Study Director
affiliation: University of the State of Santa Catarina
last name: Kettlyn Hames
role: Principal Investigator
affiliation: University of the State of Santa Catarina
last name: Jéssica Moratelli
phone: 55 48 996153470
email: jessica.moratelli@hotmail.com
last name: Adriana CA Guimarães, PhD
phone: 55 48 999811607
email: nanaguim@terra.com.br
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Sleep Wake Disorders
mesh term: Parasomnias
mesh term: Nervous System Diseases
mesh term: Gait Disorders, Neurologic
mesh term: Mobility Limitation
sharing ipd: No