Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000580077
Ethics application status
Approved
Date submitted
22/06/2010
Date registered
20/07/2010
Date last updated
20/07/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of Tai Chi Chuan on Balance in Elderly with Low Bone Mass
Scientific title
The effects of Tai Chi Chuan on balance in the elderly with low bone mass
Secondary ID [1] 252226 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Balance in the elderly with low bone mass 257635 0
Condition category
Condition code
Musculoskeletal 257813 257813 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A) Tai Chi Chuan (TCC) is considered a form of Chinese exercise that has been described as enabling gains in fitness, strength, reducing pain and stress, improved cardiorespiratory function, postural balance and reduce the risk of falls in elderly. Taking into consideration the safety of players, based on the methodology of TCC Yang Style 24 movement, adapted for the elderly, mild, with simple exercises, short choreographies and with little change in direction.
B) The practice of TCC Yang Style was performed 24 movements with a frequency of twice a week, at the same time, lessons lasting 50 minutes for 12 weeks.
C) The TCC Yang Style was practiced by 34 elderly (all the subjects), administered by physical educator
Intervention code [1] 256712 0
Treatment: Other
Comparator / control treatment
There is a control group who undergoes no treatment.
Control group
Active

Outcomes
Primary outcome [1] 258705 0
Primary Outcome 1: improve balance in Elderly with low bone mass. Data collection was performed by three instruments for analysis of body balance, the questionnaire Berg Balance Scale (BBS), Functional Reach Test (FST) and the force platform (PLAT ) AccuSway Plus brand AMTI
Timepoint [1] 258705 0
Timepoint: after 12 sections of Tai Chi Chuan are completed by participants
Secondary outcome [1] 264732 0
secondary outcome: improved agility, in Elderly with low bone mass.Data collection was performed by "Timed Up and Go" (TUG), test
Timepoint [1] 264732 0
Timepoint: after 12 sections of Tai Chi Chuan are completed by participants

Eligibility
Key inclusion criteria
* Elderly upper 60 years old ;
* Not engaged in regular physical activity over the past three months
* Elderly that has certified doctor who informs that he is apt for Tai Chi Chuan practises.
*Elderly that has certified doctor who informs, he has low bone mass
Minimum age
60 Years
Maximum age
85 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* women who used any device to assist walking,
* symptoms such as complaints of dizziness or vertigo or that they could compromise to practical regular of physical activity or the accomplishment of some test.
*were excluded Elderly who practice regular physical activity

Study design
Purpose of the study
Prevention
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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/03/2009
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] 2707 0
Brazil
State/province [1] 2707 0

Funding & Sponsors
Funding source category [1] 257168 0
University
Name [1] 257168 0
Universidade de Brasilia
Country [1] 257168 0
Brazil
Primary sponsor type
University
Name
Universidade de Brasilia
Address
Campus Universitario Darcy Ribeiro, Brasilia - CEP 70910-900
Country
Brazil
Secondary sponsor category [1] 256438 0
None
Name [1] 256438 0
Address [1] 256438 0
Country [1] 256438 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259210 0
Committee of Ethics in Research - College of Sciences of the Health (CEP/FS)
Ethics committee address [1] 259210 0
Ethics committee country [1] 259210 0
Brazil
Date submitted for ethics approval [1] 259210 0
09/03/2009
Approval date [1] 259210 0
14/03/2009
Ethics approval number [1] 259210 0
20/09/2010

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

Contacts
Principal investigator
Name 31321 0
Address 31321 0
Country 31321 0
Phone 31321 0
Fax 31321 0
Email 31321 0
Contact person for public queries
Name 14568 0
Marisete Peralta Safons
Address 14568 0
Campus Universitario Darcy Ribeiro, Brasilia-DF - CEP 70910-900
Country 14568 0
Brazil
Phone 14568 0
+55-61-31072557
Fax 14568 0
Email 14568 0
[email protected]
Contact person for scientific queries
Name 5496 0
Nelida Amorim da Silva
Address 5496 0
/DF 150; Km 4,5; Condominio Jardim Vitoria, modulo A casa 17; Sobradinho-DF – Brasilia- Brazil / CEP- 73090904
Country 5496 0
Brazil
Phone 5496 0
+55-61-81612026
Fax 5496 0
Email 5496 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.