Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000902291
Ethics application status
Approved
Date submitted
7/10/2009
Date registered
19/10/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of an aerobic training program on pain, physical and functional performance as well as inflammatory response in elders with knee osteoarthritis- Preliminaries results.
Scientific title
Effect of an aerobic training program of 12 weeks, on pain, physical performance as well as inflammatory response in elders with knee osteoarthritis- Preliminaries results.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoarthritis of Knee. 243881 0
Condition category
Condition code
Physical Medicine / Rehabilitation 252054 252054 0 0
Physiotherapy
Musculoskeletal 252055 252055 0 0
Osteoarthritis
Inflammatory and Immune System 252056 252056 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consisted of an aerobic workout, in which the volunteers had their heart rate monitored for heart rate monitors, this training was supervised by two previously trained professionals, they recorded the volunteers' heart rate during training sessions and gave verbal feedback to them to keep the frequency target rate in the range previously established. The training had a frequency of three times weekly, the training sessions had a gradual increase in the first 30 minutes duration and the final 55 minutes long, also the training protocol was 12 weeks.
Intervention code [1] 241313 0
Rehabilitation
Comparator / control treatment
In this study, there was really a control group itself, or did not receive the treatment.Our study had one group that initially received no treatment during which we obtained our baseline, after a period of 6 weeks all volunteers received treatment.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 252984 0
The study had as main variables: pain.
The instruments used to assess pain were questionario WOMAC and visual analog scale.
Timepoint [1] 252984 0
on admission, after 6 weeks, and after 12 weeks of training.
Primary outcome [2] 253084 0
Physical performance: exercise total time this evaluated by a graded exercise test on a treadmill
Timepoint [2] 253084 0
on admission, after 6 weeks, and after 12 weeks of training.
Primary outcome [3] 253085 0
Functional performance - the test of steps which the patient had to go up and down a flight of stairs as quickly as possible safely.
Timepoint [3] 253085 0
on admission, after 6 weeks, and after 12 weeks of training.
Primary outcome [4] 253086 0
Cell activation-analysis of blood samples by flow cytometry.
Timepoint [4] 253086 0
on admission, after 6 weeks, and after 12 weeks of training.
Secondary outcome [1] 257941 0
Our study had control variables, which were the following: body mass index. The body mass index was measured the weight and height measurement, write down the values after using the following calculation: weight / height.height.Measurements were collected using a mechanical scale with a platform equipped with a stadiometer.
Timepoint [1] 257941 0
on admission, after 6 weeks, and after 12 weeks of training.
Secondary outcome [2] 257942 0
Waist-hip ratio was used in the tape which was measured at the waist with legs abducted 30 cm was collected to measure two fingers above the navel and hip cincuference legs reasons, being used, the most prominent point of the buttocks
Timepoint [2] 257942 0
on admission, after 6 weeks, and after 12 weeks of training.
Secondary outcome [3] 257943 0
Waist circumference: measure the waist of the volunteer with the legs abducted to 30 cm and the measure two fingers above the navel.
Timepoint [3] 257943 0
on admission, after 6 weeks, and after 12 weeks of training.

Eligibility
Key inclusion criteria
Diagnosis of osteoarthritis(OA) in at least one knee, based on clinical and radiographic criteria of the American College of Rheumathology.

OA with a score equal to or more than two in the visual analog scale.

Not having received a any surgical procedure in the lower limbs.

Did not undergo physical therapy or any other procedure for rehabilitation in the last three month.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Orthopedic diseases, neurological, respiratory or heart diseases that would prevent the implementation of the prposed exercises, urinary or fecal incontinence, vestibular disorders, immunosuppressed, who practiced physical exercise three times a week lasting less than 30 minutes.

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)
Telephone interview, then interview and if approved these steps according to the criteria for inclusion / exclusion, performed the tests in our 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
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/11/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
4
Accrual to date
Final
Recruitment outside Australia
Country [1] 2131 0
Brazil
State/province [1] 2131 0
Minas Gerais

Funding & Sponsors
Funding source category [1] 243836 0
Government body
Name [1] 243836 0
Fapemig (Fundacao de Amparo Pesquisa do Estado de Minas Gerais).
Country [1] 243836 0
Brazil
Funding source category [2] 243837 0
Government body
Name [2] 243837 0
CNPq ( National Counsel of Technological and Scientific Development.
Country [2] 243837 0
Brazil
Primary sponsor type
Government body
Name
Fapemig
Address
Rua Raul Pompeia, nº 101- Sao Pedro- Belo Horizonte- Minas Gerais- 30.330-080- Brasil.
Country
Brazil
Secondary sponsor category [1] 237182 0
Government body
Name [1] 237182 0
CNPq
Address [1] 237182 0
SEPN, Quadra 507, Bloco B- Asa Norte- Brasilia- Distrito Federal- 70740-901
Country [1] 237182 0
Brazil
Other collaborator category [1] 887 0
Hospital
Name [1] 887 0
Santa Casa de Caridade de Diamantina.
Address [1] 887 0
Rua da Gloria, n 105- Diamantina- Minas Gerais- 39100-000
Country [1] 887 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243967 0
Ethics Committee and Research University of the Jequitinhonha and Mucuri.
Ethics committee address [1] 243967 0
Rua da Gloria, number 187, cep 39100-000, Downtown, Dimantina, Minas Gerais.
Ethics committee country [1] 243967 0
Brazil
Date submitted for ethics approval [1] 243967 0
Approval date [1] 243967 0
17/11/2008
Ethics approval number [1] 243967 0
057/2008

Summary
Brief summary
Our study's main objective is to observe a training walk is able to reduce pain, improve performance, and improve the inflammation resulting from knee osteoarthritis in the elderly. Therefore we expect the training to reduce pain and improve physical performance and inflammatory of our volunteers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30265 0
Address 30265 0
Country 30265 0
Phone 30265 0
Fax 30265 0
Email 30265 0
Contact person for public queries
Name 13512 0
Ana Cristina Rodrigues Lacerda
Address 13512 0
Department of Physical Therapy UFVJM, Rua da Gloria, number 187, Diamantina, Minas Gerais- 39100-000
Country 13512 0
Brazil
Phone 13512 0
+55(38) 35311811
Fax 13512 0
+55(38) 35313808
Email 13512 0
[email protected]
Contact person for scientific queries
Name 4440 0
Ana Cristina Rodrigues Lacerda
Address 4440 0
Department of Physical Therapy UFVJM, Rua da Gloria, number 187, Diamantina, Minas Gerais- 39100-000
Country 4440 0
Brazil
Phone 4440 0
+55(38) 35311811
Fax 4440 0
+55(38)35313808
Email 4440 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
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