NCT03235453

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable parkinson-disease

Status
unknown

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

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2017

Completed
29 days until next milestone

Study Start

First participant enrolled

August 30, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

August 3, 2017

Status Verified

August 1, 2017

Enrollment Period

4 months

First QC Date

July 28, 2017

Last Update Submit

August 2, 2017

Conditions

Keywords

ParkinsonQuality of LifeSleep DisorderGait DisordersMobility

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

EXPERIMENTAL

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

Quaternary rhythm

EXPERIMENTAL

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

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.

Also known as: Dance
Binary 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.

Also known as: Dance
Quaternary rhythm

Eligibility Criteria

Age25 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Parkinson DiseaseSleep Wake DisordersGait Disorders, NeurologicMobility Limitation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Jéssica Moratelli

    University of the State of Santa Catarina

    PRINCIPAL INVESTIGATOR
  • Adriana CA Guimarães, PhD

    University of the State of Santa Catarina

    STUDY DIRECTOR
  • Kettlyn Hames

    University of the State of Santa Catarina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adriana CA Guimarães, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: Randomized clinical trial, two arm study (group 1 - Binary Rhythm; group 2 - Quaternary Rhythm
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