Accidental FallsDanSENCT02603523
Effects of Senior Dance on Risk Factors for Falls
A study testing Senior Dance in people with Accidental Falls, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
Trial summary
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%. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls
- What is being tested?
- Senior Dance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2016to Aug 2017
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Community-dwelling aged 60 years or over
- Cognitively intact (defined as a minimum score of 24 points on the Mini Mental Status Examination).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Accidental Falls
- Being tested
- Senior Dance
- Keywords
- accidental falls, older people, dance, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Senior DanceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Senior Dance | Experimental | 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. Receives: Behavioral: Senior Dance |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Single-leg stance with eyes closed
Measured: 12 weeks after randomization
Secondary outcomes (4)
Short Physical Performance Battery
Measured: 12 weeks after randomization
Falls Efficacy Scale - International (FES-I)
Measured: 12 weeks after randomization
Trail Making Test (TMT)
Measured: 12 weeks after randomization
The Montreal Cognitive Assessment (MOCA):
Measured: 12 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startJan 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Accidental FallsStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Minas Gerais, Universidade Cidade de Sao Paulo, University of Sydney, The George Institute
- Responsible party
- Principal investigator, Marcia Rodrigues Costa Franco, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- Marcia R Franco, PhD, Principal investigator, Departamento de Fisioterapia, Faculdade de Ciências e Tecnologia, UNESP - Universidade Estadual Paulista, Presidente Prudente, São Paulo, BrasilCarlos Marcelo Pastre, PhD, Study director, Departamento de Fisioterapia, Faculdade de Ciências e Tecnologia, UNESP - Universidade Estadual Paulista, Presidente Prudente, São Paulo, Brasil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02603523
- Sponsor's protocol ID
- 2015/07704-9
- Other IDs
- 2015
- Acronym
- DanSE
- Status last verified
- Jun 2018
- First submitted
- 10 Nov 2015
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 25456888Franco 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.
PubMed 31899491Franco 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.
PubMed 28039296
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Senior Dance on Risk Factors for Falls in Older Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02603523
- Acronym / sponsor ID
- DanSE / 2015/07704-9
- Conditions
- Accidental Falls
- Keywords
- accidental falls, older people, dance, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Collaborators
- Federal University of Minas Gerais, Universidade Cidade de Sao Paulo, University of Sydney, The George Institute
- Study start
- Jan 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 11 Nov 2015 (estimated)
- 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Senior Dance | Experimental | Behavioral: Senior DanceThe 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Community-dwelling aged 60 years or over
- Cognitively intact (defined as a minimum score of 24 points on the Mini Mental Status Examination).
Key exclusion criteria (6 listed)
- 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).
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 |
|---|---|---|
| Senior DanceThe 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. | Behavioural | Senior Dance |
Primary outcome
Single-leg stance with eyes closed
Time frame: 12 weeks after randomization
4 secondary outcomes
Short Physical Performance Battery
Time frame: 12 weeks after randomization
Falls Efficacy Scale - International (FES-I)
Time frame: 12 weeks after randomization
Trail Making Test (TMT)
Time frame: 12 weeks after randomization
The Montreal Cognitive Assessment (MOCA):
Time frame: 12 weeks after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- Background: PubMed 25456888Fernandez-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.
- Derived from this study: PubMed 31899491Franco 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.
- Derived from this study: PubMed 28039296Franco 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.
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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.
Marcia R Franco, PhD principal investigator
Departamento de Fisioterapia, Faculdade de Ciências e Tecnologia, UNESP - Universidade Estadual Paulista, Presidente Prudente, São Paulo, Brasil
Carlos Marcelo Pastre, PhD study director
Departamento de Fisioterapia, Faculdade de Ciências e Tecnologia, UNESP - Universidade Estadual Paulista, Presidente Prudente, São Paulo, Brasil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Senior Dance in people with Accidental Falls, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single-leg stance with eyes closed (time frame: 12 weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02603523, which also lists 3 linked publications.
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 19 Jun 2018.