Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000887279
Ethics application status
Approved
Date submitted
4/10/2009
Date registered
12/10/2009
Date last updated
12/10/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of a dual-task training on dynamic and static balance control of pre-frail elderly: a pilot study.
Scientific title
Immediate and short-term effects of a brief dual-task training on dynamic and static balance control of pre-frail elderly: a pilot study.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
deficit on dynamic and static balance control in pre-frail elderly 251963 0
Condition category
Condition code
Physical Medicine / Rehabilitation 252148 252148 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The research will be conducted twice a week for 45 minutes, for four weeks. The simple task training consists only in the use of a treadmill and the dual task training consists on the use of a treadmill associated with visual stimuli. The treadmill training will last 15 minutes, and the visual stimuli will last 10 minutes with 5 seconds between each image. Only the intervention group will be
submitted to the dual task training.
Intervention code [1] 241377 0
Rehabilitation
Comparator / control treatment
Active control. For the control group was used the simple task training.
Control group
Active

Outcomes
Primary outcome [1] 253021 0
Deficit on balance control and risk of falls, measured with Berg Balance Scale (BBS)
Timepoint [1] 253021 0
at baseline, immediately after intervention period and after 1 month interval.
Secondary outcome [1] 257834 0
Deficit on balance control and risk of falls, measured with a computerized posturography Balance Master
Timepoint [1] 257834 0
at baseline, immediately after intervention period and after 1 month interval.

Eligibility
Key inclusion criteria
To participate in the study it was necessary to meet the criteria defining the fragility and have been classified as pre-frail, not present neurological disorders and do not use drugs that bring harm to the balance, being able to walk independently for at least three minutes, not present cognitive impairment or dementia with a cutoff of at least 17 on the Mini-Mental Examination, have good visual acuity with or without corrective lenses, have normal blood pressure for age.
Minimum age
65 Years
Maximum age
90 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Neurological, muscleskeletal and cardiovascular diseases; use of drugs that bring balance damage

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment outside Australia
Country [1] 2221 0
Brazil
State/province [1] 2221 0
Rio Grande do Norte

Funding & Sponsors
Funding source category [1] 243838 0
University
Name [1] 243838 0
Universidade Federal do Rio Grande do Norte -UFRN
Country [1] 243838 0
Brazil
Primary sponsor type
University
Name
Universidade Federal do Rio Grande do Norte -UFRN
Address
Centro de Ciencias da Saude Departamento de Fisioterapia
Av. Senador Salgado Filho, 3000, Campus Universitario, Natal/RN, CEP: 59078-970.
Country
Brazil
Secondary sponsor category [1] 237183 0
None
Name [1] 237183 0
Address [1] 237183 0
Country [1] 237183 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243963 0
Comite de Etica da Universidade Federal do Rio Grande do Norte
Ethics committee address [1] 243963 0
Praca do Campus, Campus Universitario, CP 1666- Natal/RN.
Ethics committee country [1] 243963 0
Brazil
Date submitted for ethics approval [1] 243963 0
Approval date [1] 243963 0
Ethics approval number [1] 243963 0

Summary
Brief summary
Indeed, this research is justified by the need to determine the effects of an intervention strategy aimed at improving the static and dynamic balance in elderly women, as the falls occur largely during events which, although relatively simple and routine as walking, require frequent postural reactions, mainly due to unexpected disruptions.

Hypothesis:
The dual-task training on a treadmill, compared to simple training on a treadmill, promotes statistically significant difference in postural control of pre-frail elderly?

Objetives:
- Check the effects of training dual-task and simple task on measures of postural control in community elderly with phenotype of frailty;
- Compare the performance between groups in the evaluation tests of balance in the force platform and the Balance Scale Berg;
- Check if there was retention of training effects after one month of the end of it.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30357 0
Address 30357 0
Country 30357 0
Phone 30357 0
Fax 30357 0
Email 30357 0
Contact person for public queries
Name 13604 0
Ricardo Oliveira Guerra
Address 13604 0
Centro de Ciencias da Saude – Departamento de Fisioterapia
Av. Senador Salgado Filho, 3000, Campus Universitario, Natal/RN, CEP: 59078-970.
Country 13604 0
Brazil
Phone 13604 0
+55 84 3215-3135
Fax 13604 0
Email 13604 0
[email protected]
Contact person for scientific queries
Name 4532 0
Viviane Silva Ribeiro
Address 4532 0
Rua Jose Goncalves de Abrantes, 129, Jardim Oceania, Joao Pessoa- PB
CEP: 58037265
Country 4532 0
Brazil
Phone 4532 0
+55 83 32463078
Fax 4532 0
Email 4532 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.