Dance for People With Parkinson's Disease
Influence of Binary and Quaternary Rhythm in Motor Symptoms, Sleep, Failure and Quality of Living in People With Parkinson Disease: a Randomized Clinical Trial
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable parkinson-disease
Started Aug 2017
Typical duration for not_applicable parkinson-disease
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2017
CompletedFirst Posted
Study publicly available on registry
August 1, 2017
CompletedStudy Start
First participant enrolled
August 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2019
CompletedAugust 3, 2017
August 1, 2017
4 months
July 28, 2017
August 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Balance
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
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
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 Outcomes (4)
Quality of life
5 minutes
Sleep
5 minutes
Daytime sleepiness
5 minutes
Fatigue
5 minutes
Study Arms (2)
Binary rhythm
EXPERIMENTALExperimental: 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).
Quaternary rhythm
EXPERIMENTALThe 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).
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Individuals who do not complete all study steps.
- That they are not stable in doses of medication.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2017
First Posted
August 1, 2017
Study Start
August 30, 2017
Primary Completion
December 30, 2017
Study Completion
December 20, 2019
Last Updated
August 3, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share