Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000472471
Ethics application status
Approved
Date submitted
14/08/2007
Date registered
19/09/2007
Date last updated
27/04/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Progressive Load Training for the Quadriceps Muscle Associated to Proprioception Exercises for the Prevention of Falls in Postmenopausal Women with Osteoporosis: a randomized controlled trial
Scientific title
Eighteen weeks of Progressive Load Training for the Quadriceps Muscle Associated to Proprioception Exercises for the Prevention of Falls in Postmenopausal Women with Osteoporosis: a randomized controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postmenopausal women with osteoporosis 2252 0
Condition category
Condition code
Physical Medicine / Rehabilitation 2343 2343 0 0
Physiotherapy
Musculoskeletal 2407 2407 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention 2 times a week for 18 weeks, 50 patients per group Group 1: exercises of proprioception, balance (Balance was realized in dynamic and static for a period of 30min, Walking on the tips of the toes and the heel, walking sideways, walking for a while with leg contra-lateral arm, standing on one leg, and standing in the tandem position, with gradually increasing the period of permanence in these last two static position. Elastic Jump), and muscular strength (exercisers to the extension muscles of the knee) and stretching exercisers. group 2: control group
Both groups receive treatment clinical (medication) for osteoporosis.
Intervention code [1] 2028 0
Rehabilitation
Comparator / control treatment
placebo:after 18 weeks - education about devices that prevent falls
Control group
Placebo

Outcomes
Primary outcome [1] 3238 0
Function,
Timed up and go test,
Berg Balance Scale,
1RM (one repetition maximum) quadriceps muscle
Timepoint [1] 3238 0
An initial assessment on first week and a last assessment after 18 weeks and 6 weeks follow-up
Secondary outcome [1] 5406 0
Short Form - 36,
Number of falls
Timepoint [1] 5406 0
An initial assessment on first week and a last assessment after 18 weeks and 6 weeks follow-up

Eligibility
Key inclusion criteria
Inclusion: Females, ages varying from 55-75, bone mineral density with a T-score below – 2.5 of standard deviation in the spine or femur according to the criteria established by WHO (World Health Organization), with no regular physical exercise practice three months before.
Minimum age
55 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion: severe visual deficiency, severe hearing impairment, important vestibular changes, use of assistive gait devices (orthosis and or prosthesis), absolute contraindications for the practice of physical exercises according to the American College of Sports Medicine, other diseases that may affect muscular strength, balance or flexibility and the use of medications prescribed for the reduction of balance.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/02/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 562 0
Brazil
State/province [1] 562 0

Funding & Sponsors
Funding source category [1] 2499 0
Other
Name [1] 2499 0
Federal University of Sao Paulo and
Ambulatory of Specialities of Grajau - University of Santo Amaro
Country [1] 2499 0
Brazil
Primary sponsor type
University
Name
Lucas Emmanuel Pedro de Paiva Teixeira
Address
Rua Pedro de Toledo 598
Country
Brazil
Secondary sponsor category [1] 2272 0
University
Name [1] 2272 0
Virginia Fernandes Moca trevisani
Address [1] 2272 0
Rua Pedro de Toledo 598
Country [1] 2272 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4410 0
Ethics Committee - Federal University of Sao Paulo
Ethics committee address [1] 4410 0
Rua Botucatu 572
Ethics committee country [1] 4410 0
Brazil
Date submitted for ethics approval [1] 4410 0
12/12/2006
Approval date [1] 4410 0
12/01/2007
Ethics approval number [1] 4410 0
ID: CEP 1910/06

Summary
Brief summary
Objective of the study: to verify the efficiency of the balance training, proprioception, and muscle strength exercises concerning the improvement of the functional capacity and quality of life of women with osteoporosis, through validated questionnaires and functional tests.

Hypothesis:
Proprioception, balance and muscle strength trainings are effective in the falls prevention and reduction of its risk factors, improving the quality of life and functional capacity of patients with osteoporosis, through the acceleration of their motor responses, improving therefore the performance of their daily life activities.
Trial website
www.unifesp.br
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27982 0
Address 27982 0
Country 27982 0
Phone 27982 0
Fax 27982 0
Email 27982 0
Contact person for public queries
Name 11139 0
Lucas Emmanuel Pedro de Paiva Teixeira
Address 11139 0
Rua Pedro de Toledo 598
Country 11139 0
Brazil
Phone 11139 0
55-11-76810702
Fax 11139 0
Email 11139 0
[email protected]
Contact person for scientific queries
Name 2067 0
Virgínia Fernandes Moça Trevisani
Address 2067 0
Rua Pedro de Toledo 598
Country 2067 0
Brazil
Phone 2067 0
55-11-55752970
Fax 2067 0
Email 2067 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.