Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000331336
Ethics application status
Approved
Date submitted
1/07/2008
Date registered
15/07/2008
Date last updated
15/07/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of heating by short waves and aerobic activity on stretching of the back thigh muscles - a comparative study
Scientific title
Effects of heating by short waves and aerobic activity on stretching of the back thigh muscles - a comparative study
Secondary ID [1] 627 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stretching 3411 0
Condition category
Condition code
Musculoskeletal 3502 3502 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study involved 30 young people, (15 male/15 female), equally divided into three groups: (G1) control, only-stretching group; (G2) stretching group, preceded by heat using short waves diathermy in the origin
(ischial tuberosity) and insertion (popliteal fossa) of the back thigh muscles (20 minutes); (G3) stretching group, preceded by heat using a cycle ergometer (15 minutes). Every session involved the heat preceding the stretch (except G1, not heated). 10 interventions sessions per subject were made, with the same stretching mode between the groups, to evaluate the influence of the muscle heating by short waves and aerobic activity before the stretching on the back thigh muscles flexibility in the young healthy population. Every stretching was repeated 3 times, with 30 seconds duration and 30 seconds relax between the stretches. The intervention sessions were conducted 5 days per week, with 24 hours interval, during 2 weeks, totaling 10 intervention sessions per subject. The stretches involved static mode, with maximum flexion of the hip joint (limited for the maximum stretching sensation for the subject), knee joit in total extension and the ankle joint in neutral position. The evaluation, heating and stretching procedures (in all subjects) was conducted only in the dominant side of the subject (i.e. if subjects writes with left hand, receive the procedures in the left side; if subjects writes with right hand, receive the procedures in the right side).
Intervention code [1] 3139 0
Rehabilitation
Comparator / control treatment
Only-stretching group. 10 stretching sessions per subject. The sessions were conducted 5 days per week, with 24 hours interval, during 2 weeks, totaling 10 sessions per subject.
Control group
Active

Outcomes
Primary outcome [1] 4430 0
Range of motion (ROM) measures was assessed with goniometer and fleximeter and the results was compared after 10 sessions.
Timepoint [1] 4430 0
After every session (10 sessions per subject).
Secondary outcome [1] 7476 0
Nil
Timepoint [1] 7476 0
Nil

Eligibility
Key inclusion criteria
not to be practicing of physical activity and accept not to participate of a exercise program during the period of study; present popliteal angle lesser or equal 150 degrees and the extended leg elevation test lesser or equal 80 degrees; Thomas' test negative; not to present not definitively treated skeletal muscles injuries; not to present bone blocks in the low extremity articulations; not to present hipermobility in the articulations.
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for G1: not to fill the inclusion criteria; G2: not to fill the inclusion criteria and to present counter indications of the use of the deep heating; G3: not to fill the inclusion criteria; cardiovascular disease, engaged thermal sensation and not cooperative's patients. All these criteria (inclusion and exclusion) had been verified in an initial questionnaire filled previously to the admission of the citizens in the research.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
In a jar with 30 balls inside (10 balls with the signature "G1", 10 balls with the signature "G2" and 10 balls with the signature "G3"; Every subject taked one ball, and the ball define his group.
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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/04/2008
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] 1009 0
Brazil
State/province [1] 1009 0
Brasilia

Funding & Sponsors
Funding source category [1] 3598 0
Hospital
Name [1] 3598 0
Hospital da Universidade Catolica de Brasilia
Country [1] 3598 0
Brazil
Primary sponsor type
University
Name
Universidade Catolica de Brasília
Address
QS 07 Lote 1 Águas Claras - Taguatinga/DF
Country
Brazil
Secondary sponsor category [1] 3234 0
Hospital
Name [1] 3234 0
Hospital da Universidade Catolica de Brasilia
Address [1] 3234 0
QS 05, Lote 22, Av. Areal - Aguas Claras - DF
Country [1] 3234 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5644 0
Comite de etica em pesquisa - UCB
Ethics committee address [1] 5644 0
Ethics committee country [1] 5644 0
Brazil
Date submitted for ethics approval [1] 5644 0
28/02/2008
Approval date [1] 5644 0
21/03/2008
Ethics approval number [1] 5644 0
11

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

Contacts
Principal investigator
Name 28716 0
Address 28716 0
Country 28716 0
Phone 28716 0
Fax 28716 0
Email 28716 0
Contact person for public queries
Name 11873 0
Rogerio Moreira Parente
Address 11873 0
Setor Habitacional Vicente Pires Rua 08 Ch.199 Casa 11
Country 11873 0
Brazil
Phone 11873 0
(61) 35971746
Fax 11873 0
Email 11873 0
[email protected]
Contact person for scientific queries
Name 2801 0
Rogerio Moreira Parente
Address 2801 0
Setor Habitacional Vicente Pires Rua 08 Ch.199 Casa 11
Country 2801 0
Brazil
Phone 2801 0
(61) 35971746
Fax 2801 0
Email 2801 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.