Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000759291
Ethics application status
Approved
Date submitted
29/08/2009
Date registered
1/09/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Physiotherapy and its effect on blood pressure
Scientific title
The effect of physiotherapy for knee osteoarthritis on blood pressure in hypertensives and normotensives
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoarthritis 243604 0
arterial hypertension 243605 0
Condition category
Condition code
Physical Medicine / Rehabilitation 239891 239891 0 0
Physiotherapy
Musculoskeletal 239895 239895 0 0
Osteoarthritis
Cardiovascular 239896 239896 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with osteoarthritis of the knee also diagnosed as hypertensives had their blood pressure assessed each 20 minutes while they were exposed to a 60 minutes physiotherapy session and during 60 minutes of resting. The physiotherapy session was conducted on one occasion only for the purposes of this trial. It was divided in three stages of 20 minutes: a) analgesia - provided by cryotherapy and knee passive mobilization. b) Proprioception and strengthening - proprioceptive exercises were appropriated for the initial phase of treatment, followed by isometric exercises to strengthen the muscles of the hip and knee. c) Stretching -passive stretching of ischio-tibial, hip abductors and adductors, triceps suraed and quadriceps was performed.
Intervention code [1] 241192 0
Rehabilitation
Comparator / control treatment
Patients without osteoarthritis and hypertension underwent the same treatment.
Control group
Active

Outcomes
Primary outcome [1] 240678 0
Blood pressure measured by an automatic sphygmomanometer.
Timepoint [1] 240678 0
Blood pressure was measured at 0, 20, 40, 60, 80, 100 and 120 minutes after the beginning of the session.
Secondary outcome [1] 257316 0
Nil
Timepoint [1] 257316 0
Nil

Eligibility
Key inclusion criteria
Esperimental group: patients with osteoarthritis whose Lequesne Index was below 14, with a medical diagnosis of arterial hypertension and under drug treatment. Control group: patients without osteoarthritis and with blood pressure less than 120/80.
Minimum age
45 Years
Maximum age
81 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Diseases (other than knee osteoarthritis) or surgical procedures that could affect lower limbs. Use of nonsteroidal antiinflammatory drugs during the preceding 24 hours.

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)
The primary approach to subjects was via medical records of the institution. Hypertensives with knee osteoarthritis were approached and had their Lequesne Index determined. Those who fulfilled inclusion criteria signed informed consent and were enrolled in the study.
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
2/05/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
49
Accrual to date
Final
Recruitment outside Australia
Country [1] 1964 0
Brazil
State/province [1] 1964 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 237549 0
Self funded/Unfunded
Name [1] 237549 0
Jose Luiz Tatagiba Lamas
Country [1] 237549 0
Brazil
Primary sponsor type
Individual
Name
Jose Luiz Tatagiba Lamas
Address
Departamento de Enfermagem
R. Tessalia Vieira de Camargo, 126
Cidade Universitaria Zeferino Vaz
13083-970 - Campinas - SP
Country
Brazil
Secondary sponsor category [1] 237027 0
None
Name [1] 237027 0
Nil
Address [1] 237027 0
Nil
Country [1] 237027 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243684 0
Committee of Ethics in Research of the Faculty of Medical Sciences of Campinas State University
Ethics committee address [1] 243684 0
Ethics committee country [1] 243684 0
Brazil
Date submitted for ethics approval [1] 243684 0
Approval date [1] 243684 0
Ethics approval number [1] 243684 0

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

Contacts
Principal investigator
Name 30097 0
Address 30097 0
Country 30097 0
Phone 30097 0
Fax 30097 0
Email 30097 0
Contact person for public queries
Name 13344 0
Jose Luiz Tatagiba Lamas
Address 13344 0
Departamento de Enfermagem
R. Tessalia Vieira de Camargo, 126
Cidade Universitaria Zeferino Vaz
13083-970 - Campinas - SP
Country 13344 0
Brazil
Phone 13344 0
+ 55 19 3521-8826
Fax 13344 0
+ 55 19 3521-8822
Email 13344 0
zelamas@fcm.unicamp.br
Contact person for scientific queries
Name 4272 0
Jose Luiz Tatagiba Lamas
Address 4272 0
Departamento de Enfermagem
R. Tessalia Vieira de Camargo, 126
Cidade Universitaria Zeferino Vaz
13083-970 - Campinas - SP
Country 4272 0
Brazil
Phone 4272 0
+ 55 19 3521-8826
Fax 4272 0
+ 55 19 3521-8822
Email 4272 0
zelamas@fcm.unicamp.br

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.