- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02603523
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
Study Type
Interventional
Enrollment (Actual)
82
Phase
- 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
-
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São Paulo
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Presidente Prudente, São Paulo, Brazil, 19.060-900
- Unesp
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-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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
Outcome Measure |
Time Frame |
|---|---|
|
Single-leg stance with eyes closed
Time Frame: 12 weeks after randomization
|
12 weeks after randomization
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Short Physical Performance Battery
Time Frame: 12 weeks after randomization
|
12 weeks after randomization
|
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Falls Efficacy Scale - International (FES-I)
Time Frame: 12 weeks after randomization
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12 weeks after randomization
|
|
Trail Making Test (TMT)
Time Frame: 12 weeks after randomization
|
12 weeks after randomization
|
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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.
Collaborators
Investigators
- 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
- Fernandez-Arguelles EL, Rodriguez-Mansilla J, Antunez LE, Garrido-Ardila EM, Munoz RP. Effects of dancing on the risk of falling related factors of healthy older adults: a systematic review. Arch Gerontol Geriatr. 2015 Jan-Feb;60(1):1-8. doi: 10.1016/j.archger.2014.10.003. Epub 2014 Nov 6.
- Franco MR, Sherrington C, Tiedemann A, Pereira LS, Perracini MR, Faria CSG, Negrao-Filho RF, Pinto RZ, Pastre CM. Effect of Senior Dance (DanSE) on Fall Risk Factors in Older Adults: A Randomized Controlled Trial. Phys Ther. 2020 Apr 17;100(4):600-608. doi: 10.1093/ptj/pzz187.
- Franco MR, Sherrington C, Tiedemann A, Pereira LS, Perracini MR, Faria CR, Pinto RZ, Pastre CM. Effectiveness of Senior Dance on risk factors for falls in older adults (DanSE): a study protocol for a randomised controlled trial. BMJ Open. 2016 Dec 30;6(12):e013995. doi: 10.1136/bmjopen-2016-013995.
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)
January 1, 2016
Primary Completion (Actual)
August 1, 2017
Study Completion (Actual)
August 1, 2017
Study Registration Dates
First Submitted
November 10, 2015
First Submitted That Met QC Criteria
November 10, 2015
First Posted (Estimate)
November 11, 2015
Study Record Updates
Last Update Posted (Actual)
June 19, 2018
Last Update Submitted That Met QC Criteria
June 16, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Other Study ID 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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