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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effects of Balance Exercises on Postural Control and Gait in Older Women with risk of Falls
Scientific title
The Effects of Balance Exercises On Postural Sway And Gait In Pre Frail Older Women at Risk of Falls
Secondary ID [1] 252896 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postural Instability 258425 0
Condition category
Condition code
Physical Medicine / Rehabilitation 258592 258592 0 0

Study type
Description of intervention(s) / exposure
Exercise Group trained classes with static and dynamic balance exercises. Balance disks and tables, foams and balls were used for the exercises. The program was composed by exercises that trained postural control during bipodal and unipodal stance, altering surfaces and visual information, avoid obstacles and ankle and hip strategy. Exercises were performed in groups with a physiotherapist, 1 hour twice a week for 12 week.
Intervention code [1] 257425 0
Comparator / control treatment
Control group trained classes with stretching and active range of motion exercises for upper limbs. Subjects performed active exercises like shoulder flexion, abduction and rotation (without resistance), scapular adduction (with theraband) and elbow flexion and extension (without resistance). Subjects also underwent stretching of cervical and lumbar muscles (seating position). Exercises were performed in groups with a physiotherapist, 1 hour once a week for 12 week.
Control group

Primary outcome [1] 259443 0
Linear and nonlinear measures of postural fluctuations assessed during a quiet upright standing on a force plate
Timepoint [1] 259443 0
Baseline and 12 week after intervention commencement
Primary outcome [2] 259444 0
Temporal and spatial parameters of gait, assessed by GAITRite System
Timepoint [2] 259444 0
Baseline and 12 week after intervention commencement
Secondary outcome [1] 265993 0
Falls ocurrence. Subjects were asked weekly about the ocurrence of falls. Falls were recorded in weekly interviews.
Timepoint [1] 265993 0
Baseline, and at 3, 6, 9 and 12 month after intervention commencement
Secondary outcome [2] 265994 0
Falls Efficacy Scale-International (FES-I - Brasil) score
Timepoint [2] 265994 0
Baseline and 12 week after intervention commencement
Secondary outcome [3] 265995 0
Time of Sit to Stand test (5 repetitions)
Timepoint [3] 265995 0
Baseline and 12 week after intervention commencement
Secondary outcome [4] 265996 0
Time of Semi-tandem stance test
Timepoint [4] 265996 0
Baseline and 12 week after intervention commencement
Secondary outcome [5] 265997 0
Time of Alternate Step Test (8 repetitions)
Timepoint [5] 265997 0
Baseline and 12 week after intervention commencement

Key inclusion criteria
Community-dwelling older adults; age 65 yeras or over; history of at least one fall 12 months prior to data collection; pre-frail according Phenotype of Frailty; ability to walk 6 meters without human assistance.
Minimum age
65 Years
Maximum age
100 Years
Can healthy volunteers participate?
Key exclusion criteria
Cognitive impairment; neurologic conditions like Parkinson and stroke; initiate any intervention after randomization.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
the person who determined if a subject was eligible for inclusion in the trial was unaware, when this decision was made, to which group the subject would be allocated, because allocation was done by another investigator, after the subject was included in the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Active, not recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 2977 0
State/province [1] 2977 0
Minas Gerais

Funding & Sponsors
Funding source category [1] 257861 0
Government body
Name [1] 257861 0
Conselho Nacional de Desenvolvimento Cientifico e Tecnologico (CNPq)
Address [1] 257861 0
SEPN 507, Bloco "B", Ed. Sede CNPq
70740-901 Brasilia, DF.
Country [1] 257861 0
Funding source category [2] 257862 0
Government body
Name [2] 257862 0
FAPEMIG - Fundacao de Amparo a Pesquisa do Estado de Minas Gerais
Address [2] 257862 0
Rua Raul Pompeia, 101 - Sao Pedro - Belo Horizonte - Minas Gerais - 30.330-080 - Brasil
Country [2] 257862 0
Primary sponsor type
Universidade Federal de Minas Gerais
Avenida Antonio Carlos, 6627 - Pampulha
31270-901 - Belo Horizonte - MG
Secondary sponsor category [1] 257066 0
Name [1] 257066 0
Paula Maria Machado Arantes
Address [1] 257066 0
Rua Ramalhete, 115/102. Bairro Anchieta. CEP 30310-310. Belohorizonte, Minas Gerais.
Country [1] 257066 0

Ethics approval
Ethics application status
Ethics committee name [1] 259895 0
Comite de Etica em Pesquisa - COEP da UFMG
Ethics committee address [1] 259895 0
Av. Antonio Carlos, 6627
Unidade Administrativa II - 2. andar - Sala 2005
Campus Pampulha
Belo Horizonte, MG - Brasil
Ethics committee country [1] 259895 0
Date submitted for ethics approval [1] 259895 0
Approval date [1] 259895 0
Ethics approval number [1] 259895 0

Brief summary
The purpose of the study was to evaluate the effects of a program with balance exercises on postural control, gait, falls and fear of falling of older women with history of falls. Exercises trained center of gravity control during challenge situations
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 31790 0
Address 31790 0
Country 31790 0
Phone 31790 0
Fax 31790 0
Email 31790 0
Contact person for public queries
Name 15037 0
Paula Maria Machado Arantes
Address 15037 0
Rua Ramalhete, 115 apto 102. Bairro Anchieta. CEP:30.310-310.
Belo Horizonte - Minas Gerais.
Country 15037 0
Phone 15037 0
55 31 32254106
Fax 15037 0
Email 15037 0
Contact person for scientific queries
Name 5965 0
Joao Marcos Domingues Dias
Address 5965 0
Av. Antonio Carlos, 6627
Escola de Educacao Fisica, Fisioterapia e Terapia Ocupacional
Campus Pampulha
Belo Horizonte, MG - Brasil
Country 5965 0
Phone 5965 0
55 31 34094781
Fax 5965 0
Email 5965 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary