Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000970044
Ethics application status
Approved
Date submitted
16/10/2010
Date registered
11/11/2010
Date last updated
11/11/2010
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
NILL
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
Physiotherapy

Intervention/exposure
Study type
Interventional
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
Rehabilitation
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
Active

Outcomes
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

Eligibility
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
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Cognitive impairment; neurologic conditions like Parkinson and stroke; initiate any intervention after randomization.

Study design
Purpose of the study
Treatment
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 2977 0
Brazil
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)
Country [1] 257861 0
Brazil
Funding source category [2] 257862 0
Government body
Name [2] 257862 0
FAPEMIG - Fundacao de Amparo a Pesquisa do Estado de Minas Gerais
Country [2] 257862 0
Brazil
Primary sponsor type
University
Name
Universidade Federal de Minas Gerais
Address
Avenida Antonio Carlos, 6627 - Pampulha
31270-901 - Belo Horizonte - MG
Country
Brazil
Secondary sponsor category [1] 257066 0
Individual
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
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259895 0
Comite de Etica em Pesquisa - COEP da UFMG
Ethics committee address [1] 259895 0
Ethics committee country [1] 259895 0
Brazil
Date submitted for ethics approval [1] 259895 0
11/12/2007
Approval date [1] 259895 0
06/05/2008
Ethics approval number [1] 259895 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
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
Brazil
Phone 15037 0
55 31 32254106
Fax 15037 0
Email 15037 0
[email protected]
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
31270-901
Country 5965 0
Brazil
Phone 5965 0
55 31 34094781
Fax 5965 0
Email 5965 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.