Effects of Senior Dance on Risk Factors for Falls (DanSE)

June 16, 2018 updated by: Marcia Rodrigues Costa Franco, Universidade Estadual Paulista Júlio de Mesquita Filho

Effects of Senior Dance on Risk Factors for Falls in Older Adults: A Randomized Controlled Trial

The efficacy of exercise programs to prevent falls among older people is well documented in the literature. However, older people's adherence to these exercise programs has been reported to be suboptimal, varying between 21% and 74%. In addition, about 45% of people aged over 60 years do not meet the minimum recommended level of physical activity. In this context, dance is a promising alternative to traditional exercise programs, as it can positively influence important risk factors for falls, such as sedentary lifestyle, balance impairments and muscle weakness. Nevertheless, a recent systematic review conducted in this area show that the lack of randomized clinical trials as well as the low methodological quality of existing studies do not allow to reach definitive conclusions on the real effects of dance on risk factors for falls. A type of dance that is becoming popular among the older population in Brazil is the Senior Dance. Senior Dance classes consist of different choreographies, which include rhythmic and simple movements with rhythmic folk songs. The concentration required to learn the choreographies challenges balance, motor coordination and cognitive function. Thus the present study is a randomized clinical trial aiming to investigate the Senior Dance effect on balance, mobility and cognitive function, compared with a control group, among older people living in the community. A total of 82 subjects will be randomly allocated into two groups. The intervention group will participate in a 12-week, twice-weekly group-based program of Senior Dance, while the control will be encouraged to maintain their current routine activities. Outcomes measures (balance, mobility and cognitive function) will be evaluated before and after the intervention by an assessor blinded to group allocation. The results of this study will assist health practitioners when prescribing intervention for the older population.

Study Overview

Status

Status

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

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.

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 (Actual)

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.
82

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 Locations

  • Brazil
    • São Paulo
      • Presidente Prudente, São Paulo, Brazil, 19.060-900
        • UNESP

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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Community-dwelling aged 60 years or over
  • Cognitively intact (defined as a minimum score of 24 points on the Mini Mental Status Examination).

Exclusion criteria:

  • Previous stroke with severe neurological impairment
  • Progressive neurological disease
  • Severe visual deficiency, dizziness or vertigo for less than 3 months
  • Inability to maintain a standing position, even with the use of a walking aid or other device
  • Any illness that the physician considers as an exercise contra-indication (e.g. uncontrolled angina, acute coronary disease).
  • Participants who are currently participating in regular exercise programs including strength training and balance challenge, such as supervised group exercise, Tai Chi, Yoga, or any dance activity.

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: Parallel Assignment
  • Masking: Single

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: Senior Dance
The intervention group will attend a single educational class on fall risk factors and prevention, and will participate in a 12-week, twice-weekly group-based program of Senior Dance. Each dance class will last for an hour, and the number of participants per class will range from 10 to 15. Senior Dance-certified instructors will lead the classes. The Senior Dance classes consist of different choreographies, which include rhythmic and simple movements with rhythmic folk songs. During the classes, participants can practice the movements sitting or standing, quickly or slowly, in circles, individually, in pairs or in small groups.
Behavioral: Senior Dance
The Senior Dance classes consist of different choreographies, which include rhythmic and simple movements with rhythmic folk songs. During the classes, participants can practice the movements sitting or standing, quickly or slowly, in circles, individually, in pairs or in small groups. The concentration required to learn the choreographies challenges balance, motor coordination and cognitive function.
No Intervention: Control group
Participants in the control group will attend the same educational class on fall risk factors and prevention that intervention group participants will receive, and will be instructed not to take part in any regular exercise programs such as supervised group exercise, Tai Chi, Yoga, or any dance activity during the study period. At the end of the study, they will be offered Senior Dance classes, twice a week, during 12 weeks.

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
Time Frame
Single-leg stance with eyes closed
Time Frame: 12 weeks after randomization
12 weeks after randomization

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
Time Frame
Short Physical Performance Battery
Time Frame: 12 weeks after randomization
12 weeks after randomization
Falls Efficacy Scale - International (FES-I)
Time Frame: 12 weeks after randomization
12 weeks after randomization
Trail Making Test (TMT)
Time Frame: 12 weeks after randomization
12 weeks after randomization
The Montreal Cognitive Assessment (MOCA):
Time Frame: 12 weeks after randomization
12 weeks after randomization

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.
Universidade Estadual Paulista Júlio de Mesquita Filho

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Federal University of Minas Gerais
Universidade Cidade de Sao Paulo
University of Sydney
The George Institute

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: Marcia R Franco, PhD, Departamento de Fisioterapia, Faculdade de Ciências e Tecnologia, UNESP - Universidade Estadual Paulista, Presidente Prudente, São Paulo, Brasil
  • Study Director: Carlos Marcelo Pastre, PhD, Departamento de Fisioterapia, Faculdade de Ciências e Tecnologia, UNESP - Universidade Estadual Paulista, Presidente Prudente, São Paulo, Brasil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

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.
January 1, 2016

Primary Completion (Actual)

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.
August 1, 2017

Study Completion (Actual)

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.
August 1, 2017

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).
November 10, 2015

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.
November 10, 2015

First Posted (Estimate)

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.
November 11, 2015

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.
June 19, 2018

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.
June 16, 2018

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.
June 1, 2018

More Information

Terms related to this study

Keywords

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.
  • 2015/07704-9

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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