Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000285358
Ethics application status
Approved
Date submitted
23/02/2008
Date registered
4/06/2008
Date last updated
4/06/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of stretching and warmup exercises in the elderly
Scientific title
Chronic effects of a regular program of stretching and warm-up exercise on muscular flexibility and isokinetic torque in elderly
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
deficit of muscle flexibility in elderly 2865 0
Condition category
Condition code
Physical Medicine / Rehabilitation 2999 2999 0 0
Physiotherapy
Musculoskeletal 3000 3000 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Stretch sessions (6 x 30s, 30s rest intervals) were conducted 3 days a week for 4 weeks. warm-up exercise was made as follow: The dominant limb performed isotonic knee flexion exercises with a 1 kg weight strapped with velcro above the ankle. The knee flexion exercises were performed continually for the entire range of motion at a rate of 20 repetitions per minute (eccentric and concentric phases) for 3 minutes. The warm-up frequency was the same used for stretching. Only one group was submitted to Warm-up
Intervention code [1] 2595 0
Rehabilitation
Comparator / control treatment
active control, no treatment. subjects serve as their own control (A-B-A system)
Control group
Active

Outcomes
Primary outcome [1] 3881 0
deficit of knee extension. measured with universal goniometer
Timepoint [1] 3881 0
at baseline and after each phases of A-B-A system with 4 weeks intervals.
Primary outcome [2] 3882 0
active and passive peak torque of the knee flexors at 60/s. measured with Biodex System 3
Timepoint [2] 3882 0
at baseline and after each phase of A-B-A system with 4 weeks intervals
Primary outcome [3] 3883 0
passive peak torque of the knee flexors at 2/s. measured with Biodex System 3
Timepoint [3] 3883 0
at baseline and after each phases of A-B-A system with 4 weeks intervals.
Secondary outcome [1] 6525 0
reach in sit and reach test (mm). measured with sit and reach box
Timepoint [1] 6525 0
at baseline and after each phases of A-B-A system with 4 weeks intervals.

Eligibility
Key inclusion criteria
age between 60-80 years and déficit of knee flexibility >20°
Minimum age
60 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
muscleskeletal and cardiovascular diseases

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/06/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 801 0
Brazil
State/province [1] 801 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 3118 0
University
Name [1] 3118 0
Federal University of S?o Carlos
Country [1] 3118 0
Brazil
Primary sponsor type
University
Name
Federal University of São Carlos
Address
Rodovia Washington Luis, km 235. São Carlos - São Paulo
Country
Brazil
Secondary sponsor category [1] 2806 0
None
Name [1] 2806 0
Address [1] 2806 0
Country [1] 2806 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5476 0
Ethics Comittee of Federal University Of S?o Carlos
Ethics committee address [1] 5476 0
Ethics committee country [1] 5476 0
Brazil
Date submitted for ethics approval [1] 5476 0
16/04/2007
Approval date [1] 5476 0
17/05/2007
Ethics approval number [1] 5476 0
126/2007

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

Contacts
Principal investigator
Name 28398 0
Address 28398 0
Country 28398 0
Phone 28398 0
Fax 28398 0
Email 28398 0
Contact person for public queries
Name 11555 0
Tania de Fátima Salvini
Address 11555 0
Rodovia Washington Luis, km 235. Departamento de Fisioterapia, UFSCar, São Carlos - São Paulo
Country 11555 0
Brazil
Phone 11555 0
(16) 3351-8345
Fax 11555 0
(16) 3361-2081
Email 11555 0
[email protected]
Contact person for scientific queries
Name 2483 0
José Jamacy de Almeida Ferreira
Address 2483 0
Rodovia Washington Luis, km 235. Departamento de Fisioterapia, UFSCar, São Carlos - São Paulo
Country 2483 0
Brazil
Phone 2483 0
(16) 3351-8345
Fax 2483 0
(16) 3361-2081
Email 2483 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.