Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000780257
Ethics application status
Approved
Date submitted
5/09/2009
Date registered
9/09/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness Of The Endurance Training To The Fatigue Of The Muscles Of The Inferior Limbs Inside And Out Of Water On The Static And Dynamic Balance Of The Elderly
Scientific title
Effectiveness Of The Endurance Training To The Fatigue Of The Muscles Of The Inferior Limbs Inside And Out Of Water On The Static And Dynamic Balance Of The Elderly
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
compare the impact of a muscular endurance structured exercises program of the inferior limbs inside and out of water in the static and dynamic balance in the elderly 243670 0
Condition category
Condition code
Musculoskeletal 239940 239940 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Effectiveness Of The Endurance Training To The Fatigue Of The Muscles Of The Inferior Limbs Inside And Out Of Water On The Static And Dynamic Balance Of The Elderly

The training was applied by physiotherapists. The groups of exercises were submitted the a program of muscular endurance of the inferior limbs applied for 6 weeks, two weekly sessions with 40 minutes of duration each session. The volunteers were re-evaluted after 6 weeks.
Intervention code [1] 241220 0
Prevention
Comparator / control treatment
Effectiveness Of The Endurance Training To The Fatigue Of The Muscles Of The Inferior Limbs Inside And Out Of Water On The Static And Dynamic Balance Of The Elderly

Control Group didn't receive any type of physioterapy intervention during the six weeks of the research. To assure still more the maintenance of the condition of this group, weekly phone calls (6 connections) were done for each member seeking attendance of their routine activities.
Control group
Active

Outcomes
Primary outcome [1] 240746 0
Dynamic corporal balance in the Elderly (tests: Dynamic Gait Index, Scale of Berg's Balance, Tandem Gait, Speed Gait)
Timepoint [1] 240746 0
6 weeks after intervention
Secondary outcome [1] 257396 0
Static corporal balance in the Elderly (test: Scale of Berg's Balance)
Timepoint [1] 257396 0
6 week after intervention

Eligibility
Key inclusion criteria
Same and superior age to 60 years and being capable to accomplish Get Up and Go Test
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
treatment physical therapy; they presented diseases breathing, heart and metabolic; they presented cognitive deficit in agreement with the Mini-exam of the mental state; they presented alterations contagious; they made use of prosthesis of inferior limbs; they made use of drugs or medicines that can interfere in the balance (nicotine, caffeine, alcohol, sedatives and tranquilizers)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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
1/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment outside Australia
Country [1] 2037 0
Brazil
State/province [1] 2037 0

Funding & Sponsors
Funding source category [1] 243603 0
University
Name [1] 243603 0
Universidade Federal dos Vales dos Jequitinhonha e Mucuri
Country [1] 243603 0
Brazil
Primary sponsor type
Individual
Name
Nubia Carelli Pereira de Avelar
Address
Beco da Paciencia, 119, Centro, Diamantina/MG, Province Code: 39100-000
Country
Brazil
Secondary sponsor category [1] 237053 0
None
Name [1] 237053 0
Address [1] 237053 0
Country [1] 237053 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 30149 0
Address 30149 0
Country 30149 0
Phone 30149 0
Fax 30149 0
Email 30149 0
Contact person for public queries
Name 13396 0
Nubia Carelli Pereira de Avelar
Address 13396 0
Beco da Paciencia, 119, Centro, Diamantina/MG, Province code: 39100-000
Country 13396 0
Brazil
Phone 13396 0
+553891972020/+553888044349
Fax 13396 0
Email 13396 0
[email protected]
Contact person for scientific queries
Name 4324 0
Nubia Carelli Pereira de Avelar
Address 4324 0
Beco da Paciencia, 119, Centro, Diamantina/MG- Province code: 39100-000
Country 4324 0
Brazil
Phone 4324 0
+553891972020/+553888044349
Fax 4324 0
Email 4324 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.