NCT02603523

Brief 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%. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

June 19, 2018

Status Verified

June 1, 2018

Enrollment Period

1.6 years

First QC Date

November 10, 2015

Last Update Submit

June 16, 2018

Conditions

Keywords

accidental fallsolder peopledancerandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Single-leg stance with eyes closed

    12 weeks after randomization

Secondary Outcomes (4)

  • Short Physical Performance Battery

    12 weeks after randomization

  • Falls Efficacy Scale - International (FES-I)

    12 weeks after randomization

  • Trail Making Test (TMT)

    12 weeks after randomization

  • The Montreal Cognitive Assessment (MOCA):

    12 weeks after randomization

Study Arms (2)

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.

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.

Interventions

Senior DanceBEHAVIORAL

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.

Senior Dance

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNESP

Presidente Prudente, São Paulo, 19.060-900, Brazil

Location

Related Publications (3)

  • 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.

    PMID: 25456888BACKGROUND
  • 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 Officials

  • Marcia R Franco, PhD

    Departamento de Fisioterapia, Faculdade de Ciências e Tecnologia, UNESP - Universidade Estadual Paulista, Presidente Prudente, São Paulo, Brasil

    PRINCIPAL INVESTIGATOR
  • Carlos Marcelo Pastre, PhD

    Departamento de Fisioterapia, Faculdade de Ciências e Tecnologia, UNESP - Universidade Estadual Paulista, Presidente Prudente, São Paulo, Brasil

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

November 10, 2015

First Posted

November 11, 2015

Study Start

January 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

June 19, 2018

Record last verified: 2018-06

Locations