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Dance for People With Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT03235453
Recruitment Status : Not yet recruiting
First Posted : August 1, 2017
Last Update Posted : August 3, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Parkinson Disease Quality of Life Sleep Disorder Gait Disorders, Neurologic Mobility Limitation Other: Binary rhythm Other: Quaternary rhythm

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Randomized clinical trial, two arm study (group 1 - Binary Rhythm; group 2 - Quaternary Rhythm
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Anticipated Study Start Date : August 30, 2017
Estimated Primary Completion Date : December 30, 2017
Estimated Study Completion Date : December 20, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Binary rhythm
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).
Other: Binary rhythm
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.
Other Name: Dance
Experimental: Quaternary rhythm
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).
Other: Quaternary rhythm
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.
Other Name: Dance


Outcome Measures

Primary Outcome Measures :
  1. Balance [ Time Frame: 10 minutes ]
    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.

  2. Gait [ Time Frame: 10 minutes ]
    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

  3. Mobility [ Time Frame: 5 minutes ]

    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



Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 5 minutes ]
    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).

  2. Sleep [ Time Frame: 5 minutes ]
    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)

  3. Daytime sleepiness [ Time Frame: 5 minutes ]
    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

  4. Fatigue [ Time Frame: 5 minutes ]
    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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03235453


Contacts
Contact: Jéssica Moratelli 55 48 996153470 jessica.moratelli@hotmail.com
Contact: Adriana CA Guimarães, PhD 55 48 999811607 nanaguim@terra.com.br

Sponsors and Collaborators
Laboratório de Pesquisa em Lazer e Atividade Física
Investigators
Principal Investigator: Jéssica Moratelli University of the State of Santa Catarina
Study Director: Adriana CA Guimarães, PhD University of the State of Santa Catarina
Principal Investigator: Kettlyn Hames University of the State of Santa Catarina
More Information

Responsible Party: Laboratório de Pesquisa em Lazer e Atividade Física
ClinicalTrials.gov Identifier: NCT03235453     History of Changes
Other Study ID Numbers: 71690317700000118
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Laboratório de Pesquisa em Lazer e Atividade Física:
Parkinson
Quality of Life
Sleep Disorder
Gait Disorders
Mobility

Additional relevant MeSH terms:
Disease
Parkinson Disease
Sleep Wake Disorders
Parasomnias
Mobility Limitation
Nervous System Diseases
Gait Disorders, Neurologic
Pathologic Processes
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders