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Trial registered on ANZCTR


Registration number
ACTRN12610000042044
Ethics application status
Approved
Date submitted
13/01/2010
Date registered
15/01/2010
Date last updated
10/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of an exercise training program on balance, muscle strength and quality of life among community-dwelling women from Sao Carlos Health Family Program area
Scientific title
Elderly women that took part in an exercise training program could present some improvement for known risk factors for falls?
Secondary ID [1] 1276 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Risk factor for falls in elderly 256514 0
Condition category
Condition code
Physical Medicine / Rehabilitation 256684 256684 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants will carry out an exercise training program that will be supervised by a physical therapist, two days per week for 12 weeks, 60 minutes each session. They will be divided into four small groups according to their own schedule preferences. Each training session will consist of stretching exercises, 4 ankle and knee muscle strengthening exercises at an intensity of 60-70% of 1 repetition maximum (2 sets of 10 repetitions ) and balance training. Static balance training will be performed through simple and double-tasks at stand on one leg, their heels and their tiptoes and tandem position. Dynamic balance training will be performed through lower support base walking. It will be included ludic activities looking for great adherence. Each session will be accompanied by music.
Intervention code [1] 255794 0
Prevention
Intervention code [2] 255801 0
Lifestyle
Intervention code [3] 255802 0
Other interventions
Comparator / control treatment
Control participants will not receive treatment during study period. They will be ask about their activities during this time. They will be invited to carry out exercise training program after outcome assessments.
Control group
Active

Outcomes
Primary outcome [1] 257574 0
Isometric and isokinetic evaluation for the ankle plantar flexors and dorsiflexors and knee extensors and flexors will be assessed using a BIODEX 2 isokinetic dynamometer.
Timepoint [1] 257574 0
at baseline and 12 weeks after randomization
Primary outcome [2] 257575 0
Posturographic analyzes will be assessed using a stable force platform BERTEC CORPORATION. The variables related to COP (center of pressure) will be area oscillation, antero-posterior (AP) and medio-lateral (ML) displacement amplitude, AP and ML displacement velocity, AP and ML oscillation frequency in bipodal stance, unipodal stance an tandem position.
Timepoint [2] 257575 0
at baseline and 12 weeks after randomization
Secondary outcome [1] 262818 0
Functional balance will be assessed through Timed Up e Go Test and Berg Balance Scale.
Timepoint [1] 262818 0
at baseline,12 weeks after randomization and 12 weeks after the end of intervention
Secondary outcome [2] 262819 0
Quality of life will be measured using the abbreviated Brazilian version of
the World Health Organization Quality of Live (WHOQOL-bref) questionnaire
Timepoint [2] 262819 0
at baseline,12 weeks after randomization and 12 weeks after the end of intervention

Eligibility
Key inclusion criteria
community dwelling women, 60 years old or older,
Minimum age
60 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants that use some walking aid; present low scores at Mini-Mental State Examination (Bertolucci et al, 1994); or present a doctor report with orthopedics, cardiologic and neurologic impairments.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization was carried out through sealed envelope. Each woman chose between two sealed envelopes that designated her for the groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by dice-rolling.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 2401 0
Brazil
State/province [1] 2401 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 256282 0
Charities/Societies/Foundations
Name [1] 256282 0
Fundacao de Amparo a Pesquisa do Estado de Sao Paulo
Country [1] 256282 0
Brazil
Primary sponsor type
Individual
Name
Mariana Chaves Aveiro
Address
Rua Espir Nicolau Bichuetti, 134
Bairro Sao Benedito
Uberaba/MG - Brazil
CEP: 38020-590
Country
Brazil
Secondary sponsor category [1] 251607 0
Individual
Name [1] 251607 0
Jorge Oishi
Address [1] 251607 0
Statistics department
Federal University of Sao Carlos
Via Washington Luis, km 235
Sao Carlos/SP - Brazil
CEP: 13565-905
Country [1] 251607 0
Brazil
Other collaborator category [1] 1022 0
Individual
Name [1] 1022 0
Patricia Driusso
Address [1] 1022 0
Physical Therapy department
Federal University of Sao Carlos
Via Washington Luis, km 235
Sao Carlos/SP - Brazil
CEP: 13565-905
Country [1] 1022 0
Brazil
Other collaborator category [2] 1023 0
Individual
Name [2] 1023 0
Julia Gianjoppe dos Santos
Address [2] 1023 0
Alameda das Gardenias, 185 - Apartment 11
CEP:13566-540
Sao Carlos/SP - Brazil
Country [2] 1023 0
Brazil
Other collaborator category [3] 1024 0
Individual
Name [3] 1024 0
Viviane Dassi Kiyoto
Address [3] 1024 0
Alameda das Gardenias, 185 - Apartment 11
CEP:13566-540
Sao Carlos/SP - Brazil
Country [3] 1024 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258375 0
Comite de Etica em Pesquisa em Seres Humanos
Ethics committee address [1] 258375 0
Ethics committee country [1] 258375 0
Brazil
Date submitted for ethics approval [1] 258375 0
Approval date [1] 258375 0
18/02/2008
Ethics approval number [1] 258375 0
0189.0.135.000-06

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

Contacts
Principal investigator
Name 30687 0
Address 30687 0
Country 30687 0
Phone 30687 0
Fax 30687 0
Email 30687 0
Contact person for public queries
Name 13934 0
Mariana Chaves Aveiro
Address 13934 0
Rua Espir Nicolau Bichuetti, 134
Uberaba/MG - Brazil
CEP: 38020-590
Country 13934 0
Brazil
Phone 13934 0
+55 16 81396722
Fax 13934 0
Email 13934 0
[email protected]
Contact person for scientific queries
Name 4862 0
Mariana Chaves Aveiro
Address 4862 0
Rua Espir Nicolau Bichuetti, 134
Uberaba/MG - Brazil
CEP: 38020-590
Country 4862 0
Brazil
Phone 4862 0
+55 16 81396722
Fax 4862 0
Email 4862 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.