Parkinson DiseaseNCT03235453
Dance for People With Parkinson's Disease
A study testing Binary rhythm and Quaternary rhythm in people with Parkinson Disease and Quality of Life, run by Laboratório de Pesquisa em Lazer e Atividade Física.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 100 years
- Conditions the study is for
- Parkinson Disease, Quality of Life, Sleep Disorder
- What is being tested?
- Binary rhythm and Quaternary rhythm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2017to 20 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Individuals who do not complete all study steps.
- That they are not stable in doses of medication.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Parkinson Disease, Quality of Life, Sleep Disorder, Gait Disorders, Neurologic, Mobility Limitation
- Being tested
- Binary rhythm, Quaternary rhythm
- Keywords
- Parkinson, Quality of Life, Sleep Disorder, Gait Disorders, Mobility
- Medical subject headings
- Parkinson Disease, Sleep Wake Disorders, Gait Disorders, Neurologic, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Binary rhythmOther
Also called Dance
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.
Quaternary rhythmOther
Also called Dance
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Quaternary rhythm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
- 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
Measured: 5 minutes
Secondary outcomes (4)
Quality of life
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).
Measured: 5 minutes
Sleep
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)
Measured: 5 minutes
Daytime sleepiness
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
Measured: 5 minutes
Fatigue
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
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start30 Aug 2017 (estimated)
- Primary completion30 Dec 2017 (estimated)
- Study completion20 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Randomized clinical trial, two arm study (group 1 - Binary Rhythm; group 2 - Quaternary Rhythm
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratório de Pesquisa em Lazer e Atividade Física
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jéssica Moratelli, Principal investigator, University of the State of Santa CatarinaAdriana CA Guimarães, PhD, Study director, University of the State of Santa CatarinaKettlyn Hames, Principal investigator, University of the State of Santa Catarina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235453
- Sponsor's protocol ID
- 71690317700000118
- Status last verified
- Aug 2017
- First submitted
- 28 Jul 2017
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03235453
- Acronym / sponsor ID
- 71690317700000118
- Conditions
- Parkinson Disease, Quality of Life, Sleep Disorder, Gait Disorders, Neurologic, Mobility Limitation
- Keywords
- Parkinson, Quality of Life, Sleep Disorder, Gait Disorders, Mobility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Laboratório de Pesquisa em Lazer e Atividade FísicaUniversity, hospital or other
- Study start
- 30 Aug 2017 (estimated)
- Primary completion
- 30 Dec 2017 (estimated)
- Study completion
- 20 Dec 2019 (estimated)
- First posted
- 1 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized clinical trial, two arm study (group 1 - Binary Rhythm; group 2 - Quaternary Rhythm
| Arm | Type | Receives |
|---|---|---|
| Binary rhythm | Experimental | Other: Binary rhythmExperimental: 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 | Experimental | Other: Quaternary rhythmThe 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). |
Who may qualify
- Ages
- 25 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Individuals who do not complete all study steps.
- That they are not stable in doses of medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Binary rhythmAlso: DanceThe 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 | Binary rhythm |
| Quaternary rhythmAlso: DanceThe 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 | Quaternary rhythm |
Primary outcome
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.
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
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
4 secondary outcomes
Quality of life
Time frame: 5 minutes
Sleep
Time frame: 5 minutes
Daytime sleepiness
Time frame: 5 minutes
Fatigue
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jéssica Moratelli principal investigator
University of the State of Santa Catarina
Adriana CA Guimarães, PhD study director
University of the State of Santa Catarina
Kettlyn Hames principal investigator
University of the State of Santa Catarina
Questions about this trial
What is this clinical trial studying?
A study testing Binary rhythm and Quaternary rhythm in people with Parkinson Disease and Quality of Life, run by Laboratório de Pesquisa em Lazer e Atividade Física.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jéssica Moratelli (55 48 996153470, jessica.moratelli@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: 10 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2017.