Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000069954
Ethics application status
Approved
Date submitted
16/12/2010
Date registered
19/01/2011
Date last updated
19/01/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of a Pilates program on balance, functional performance and quality of life in elderly people
Scientific title
Effect of a Pilates program on balance, functional performance and quality of life in elderly people aged between sixty and seventy-five years old
Secondary ID [1] 252944 0
Nil
Universal Trial Number (UTN)
U1111-1117-5748
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Balance, functional performance and quality of life in elderly people 258475 0
Condition category
Condition code
Physical Medicine / Rehabilitation 258640 258640 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
It was two weekly sessions with duration of a hour each session. The session was divided in ten minutes of stretching exercises, fourty minutes of Pilates method exercises and finally, ten minutes of respiratory exercises for back to calm and relaxation (Intervention group). The intervention had a overall duration of 8 weeks (16 sessions in total). The intervention is administered to small groups of 3 participants.
Intervention code [1] 257470 0
Rehabilitation
Intervention code [2] 257776 0
Lifestyle
Comparator / control treatment
The Control group, received a thirty minutes session with respiratory and relaxation exercises (active control). The intervention had a overall duration of 8 weeks (16 sessions in total) and twice a week.
Control group
Active

Outcomes
Primary outcome [1] 259483 0
The balance was evaluated through of Timed Up and Go and Tandem position tests.
Timepoint [1] 259483 0
The instruments and tests were applied before (baseline) and after treatment (8 weeks after baseline) to evaluate the balance.
Primary outcome [2] 259851 0
The functional performance was evaluated through Sit-to-stand,functional scope and six meters walk distance tests.
Timepoint [2] 259851 0
The instruments and tests were applied before (baseline) and after treatment (8 weeks after baseline) to evaluate functional performance.
Primary outcome [3] 259852 0
The people's quality of life was evaluated by medical outcomes Study 36-Item Short-Form Health Survey questionnaire (SF-36).
Timepoint [3] 259852 0
The instruments and tests were applied before (baseline) and after treatment (8 weeks after baseline) to evaluate quality of life.
Secondary outcome [1] 266072 0
Before the aplication of intervention in both groups, we applied a questionnaire with inclusion criterias of the study and personal informations such age, gender, ocupation, schooling, fall history, bone fractures and activies of daily living.
Timepoint [1] 266072 0
The initial questionnaire was applied before the intervention in both groups (control and intervention groups).

Eligibility
Key inclusion criteria
The inclusion criteria of our study were people aged between sixty and seventy five years old, living in Barao de Cocais, Minas Gerais.
Minimum age
60 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria of our study were: people can not use gait aid devices, they can not submit stroke, Parkinson's disease, Dementia and cognitive impairments.

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)
The participants were allocated in two groups: Intervention and Control groups through numbers conteiners. there are twelve participants in each group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The method used for allocate the participants was the simple randomization using procedures like dilce-rolling method.
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
4/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 2988 0
Brazil
State/province [1] 2988 0

Funding & Sponsors
Funding source category [1] 257923 0
Other
Name [1] 257923 0
Centro Integrado de Saude
Country [1] 257923 0
Brazil
Primary sponsor type
Individual
Name
Paula Maria Machado Arantes
Address
Rua Muzambinho, 159 - Bairro Cruzeiro, Belo Horizonte - Minas Gerais - Cep: 30.310-310
Country
Brazil
Secondary sponsor category [1] 257113 0
Individual
Name [1] 257113 0
Priscilla Pamela Santos Ferreira
Address [1] 257113 0
Rua Raimundo Apolinario, 20 - Bairro Vista Alegre - Catas Altas - Minas Gerais - Cep: 35.969-000.
Country [1] 257113 0
Brazil
Secondary sponsor category [2] 257114 0
Individual
Name [2] 257114 0
Rafaela Rodrigues Souza
Address [2] 257114 0
Rua Joao Raimundo da Silva, 96 - Capim Cheiroso, Barao de Cocais, Minas Gerais - Cep: 35.970-000
Country [2] 257114 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259936 0
Comite de Etica da Santa Casa de Misericordia de Belo Horizonte
Ethics committee address [1] 259936 0
Ethics committee country [1] 259936 0
Brazil
Date submitted for ethics approval [1] 259936 0
20/06/2010
Approval date [1] 259936 0
01/10/2010
Ethics approval number [1] 259936 0
053/2010

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

Contacts
Principal investigator
Name 31825 0
Address 31825 0
Country 31825 0
Phone 31825 0
Fax 31825 0
Email 31825 0
Contact person for public queries
Name 15072 0
Paula Maria Machado Arantes
Address 15072 0
Rua Muzambinho, 159 - Bairro Cruzeiro - Belo Horizonte - Minas Gerais - Cep: 30.310-310
Country 15072 0
Brazil
Phone 15072 0
+55 31 8492-1334
Fax 15072 0
Email 15072 0
[email protected]
Contact person for scientific queries
Name 6000 0
Rafaela Rodrigues Souza
Address 6000 0
Rua Joao Raimundo da Silva, 96 - Capim Cheiroso, Barao de Cocais, Minas Gerais - Cep: 35.970-000
Country 6000 0
Brazil
Phone 6000 0
+55 31 8708-9038
Fax 6000 0
Email 6000 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.