Dance for People With Parkinson's Disease

August 2, 2017 updated by: Laboratório de Pesquisa em Lazer e Atividade Física

Influence of Binary and Quaternary Rhythm in Motor Symptoms, Sleep, Failure and Quality of Living in People With Parkinson Disease: a Randomized Clinical Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • Dance

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
10 minutes
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
10 minutes
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
5 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
5 minutes
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)
5 minutes
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
5 minutes
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
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Laboratório de Pesquisa em Lazer e Atividade Física

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jéssica Moratelli, University of the State of Santa Catarina
  • Principal Investigator: Kettlyn Hames, University of the State of Santa Catarina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 71690317700000118

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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