Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001053213
Ethics application status
Approved
Date submitted
2/12/2009
Date registered
9/12/2009
Date last updated
10/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of muscle strength training on the muscular system, posture and balance in postmenopausal women .
Scientific title
In postmenopausal women does the muscle strength training improve the balance, strength and muscular function?
Secondary ID [1] 1175 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aging process in postmenopausal women 252321 0
Condition category
Condition code
Musculoskeletal 252508 252508 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women of exercise group performed muscular strengthening exercises of 60 minutes twice a week for three months. The exercise protocol consisted of warm-up, stretching, muscular strengthening of quadriceps, hamstring, calf muscle, paravertebral, and abdominal muscles as well as relaxing.
Muscular strength training started with 60% of one repetition maximum (1 RM) (2 series of 10-15 repetitions), achieving 85% until the end of the 3-month period (4 series of 6 repetitions each).
The exercise for the pelvic floor muscles consisted of performing 10 maximal contractions of the pelvic floor muscles kept for 6-8 seconds. At the end of a series of 10 contractions were performed three rapid contractions. The interval between a contractions was 6 seconds. The series were held in four positions: lying in the lateral, sitting, all fours and standing.
The exercise protocol was administered in groups up to 10 women by a physiotherapist.
Intervention code [1] 255626 0
Prevention
Comparator / control treatment
Women of Control Group performed no type of physical exercise during 3 months after the initial evaluation
Control group
Active

Outcomes
Primary outcome [1] 253394 0
Balance improvement. Balance was evaluated by Standing Balance Test.
Timepoint [1] 253394 0
at baseline and at 3 months after the initial evaluation
Primary outcome [2] 253395 0
Strength and muscular function improvement.
The strength was evaluated using the 1 Repetition Maximum Test and The Sit-to-Stand Test.
The function of pelvic floor muscles was evaluated using perineometer and electromyography.
Timepoint [2] 253395 0
at baseline and at 3 months after the initial evaluation
Secondary outcome [1] 262478 0
The 6-minute walking test evaluation, in order to analyze the functional exercise capacity.
Timepoint [1] 262478 0
at baseline and at 3 months after the initial evaluation

Eligibility
Key inclusion criteria
Postmenopausal women within 5 years of menopause and sedentary.
Minimum age
43 Years
Maximum age
59 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Smoking habits, hysterectomy, cardiorespiratory, neurologic and rheumatic diseases, orthopaedic problems, cognitive problems, vestibulopathies, diabetes mellitus, and recent history of bone fractures.

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)
Allocation was concealed and it was done by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software.
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
Completed
Date of first participant enrolment
Anticipated
9/04/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 2348 0
Brazil
State/province [1] 2348 0

Funding & Sponsors
Funding source category [1] 256113 0
Charities/Societies/Foundations
Name [1] 256113 0
State of Sao Paulo Foundation for Research (FAPESP)
Country [1] 256113 0
Brazil
Primary sponsor type
Individual
Name
Daniela Cristina Carvalho de Abreu
Address
Avenida Bandeirantes, 3900 - Monte Alegre
CEP 14049-900
Ribeirao Preto, SP
Country
Brazil
Secondary sponsor category [1] 251459 0
Individual
Name [1] 251459 0
Cristine Homsi Jorge Ferreira
Address [1] 251459 0
Avenida Bandeirantes, 3900 - Monte Alegre
CEP 14049-900
Ribeirao Preto, SP
Country [1] 251459 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258201 0
Human Research Ethics Committee of the Ribeirao Preto School of Medicine, University of Sao Paulo
Ethics committee address [1] 258201 0
Avenida Bandeirantes, 3900 - Monte Alegre
CEP 14049-900
Ribeirao Preto, SP
Ethics committee country [1] 258201 0
Brazil
Date submitted for ethics approval [1] 258201 0
Approval date [1] 258201 0
08/04/2008
Ethics approval number [1] 258201 0
259/CEP-CSE / FMRP-USP

Summary
Brief summary
The aging process involves several changes in the body, including progressive reduction in strength and muscular function and postural control. Studies have suggested that the decreased muscular strength in women over 50 years old may be related to a lack of the hormone estrogen resulting from the menopause. However, little is known about the effect of hypoestrogenism in the first years of menopause on the balance and also the effect of a strength exercise program on these women. Therefore the study hypothesis is that the muscular strength training can promote muscle benefits, but also have a positive effect on the balance of these women, acting preventively to reduce the risk of falls.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30565 0
Address 30565 0
Country 30565 0
Phone 30565 0
Fax 30565 0
Email 30565 0
Contact person for public queries
Name 13812 0
Daniela Cristina Carvalho de Abreu
Address 13812 0
Avenida Bandeirantes, 3900 - Monte Alegre
CEP 14049-900
Ribeirao Preto, SP
Country 13812 0
Brazil
Phone 13812 0
+55 16 36024413
Fax 13812 0
+55 16 36024413
Email 13812 0
dabreu@fmrp.usp.br
Contact person for scientific queries
Name 4740 0
Cristine Homsi Jorge Ferreira
Address 4740 0
Avenida Bandeirantes, 3900 - Monte Alegre
CEP 14049-900
Ribeirao Preto, SP
Country 4740 0
Brazil
Phone 4740 0
+55 16 36023058
Fax 4740 0
Email 4740 0
cristine@fmrp.usp.br

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
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