Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000475044
Ethics application status
Approved
Date submitted
5/06/2010
Date registered
10/06/2010
Date last updated
12/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Clinical Efficacy of Vibration Training in the Treatment of the Elderly with Knee Osteoarthritis
Scientific title
The Clinical Efficacy of Vibration Training in the Treatment of the Elderly with Knee Osteoarthritis
Secondary ID [1] 251958 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 257525 0
Condition category
Condition code
Physical Medicine / Rehabilitation 257685 257685 0 0
Physiotherapy
Musculoskeletal 257694 257694 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients performed squatting exercises on a vibrating platform over a 12-week period (vibration group; n=12);
the approximate duration of each vibration session was 15 minutes; the frequency of sessions was 3 times per week; the intensity is increased over the 12 week program; the administered one-on-one by a physiotherapist.
the range frequency of the vibration platform was 35-40 Hz ; the training and rest time during the 15 minute sessions was range squats 20-45 seconds, followed by range of rest 20- 45 seconds; the intensity is increased, weekly.
Intervention code [1] 256621 0
Rehabilitation
Comparator / control treatment
in the second group, patients performed squatting exercises without vibration over the same 12-week time period (exercise group; n=11); the approximate duration of each vibration session was 15 minutes; the frequency of sessions was 3 times per week; the intensity is increased over the 12 week program; the administered one-on-one by a physiotherapist. the training and rest time during the 15 minute sessions was range squats 20-45 seconds, followed by range of rest 20- 45 seconds; the intensity is increased, weekly. This group are also approximately 15 minutes in duration.
Control group
Active

Outcomes
Primary outcome [1] 258589 0
Composite Primary outcome: four functional performance tests including the Berg Balance Scale (BBS), the Timed Get Up and Go Test (TGUG), the Chair Stand Test (CST) and the 6-Minute Walk Test (6MWT)
Timepoint [1] 258589 0
All patients were evaluated at three different moments: three weeks before initiating training, immediately prior to training and immediately after the training program
Secondary outcome [1] 264484 0
self-report from the patients on the status of their disease, assessed using the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)
Timepoint [1] 264484 0
All patients were evaluated at three different moments: three weeks before initiating training, immediately prior to training and immediately after the training program

Eligibility
Key inclusion criteria
age > 60 years; having been diagnosed with osteoarthritis in a least one knee in accordance with the clinical and radiographic criteria of the American College of Rheumatology with a classification of I, II, III or IV according to the grading scale established by Kellgren and Lawrence; not having suffered any recent knee injury; not requiring a walking aid (walking stick, crutch, walking frame); self-report of not having been submitted to physiotherapy or any other rehabilitation procedure in the previous three months and not having used glycocorticoids for at least two months prior to initiation of the study.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients were excluded from the study if they had any orthopedic, neurological, respiratory or acute cardiac diseases that would make it impossible to perform the proposed exercise; and if they had any cognitive deficit, as indicated by a score lower than that compatible with their education level in the Mini-Mental Status Examination. In addition, patients with vestibular disorders, patients who reported being immunosuppressed or immunodeficient and those who had lost sphincter control (anal and bladder) were excluded from the trial.

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)
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
1/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment outside Australia
Country [1] 2686 0
Brazil
State/province [1] 2686 0

Funding & Sponsors
Funding source category [1] 257109 0
Government body
Name [1] 257109 0
Fundacao de Amparo a Pesquisa de Minas Gerais (FAPEMIG)
Country [1] 257109 0
Brazil
Primary sponsor type
Individual
Name
Ana Cristina Rodrigues Lacerda
Address
Departament Physical Therapy, Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Gloria's Street, n 187, downtown, 39100-000, Diamantina, MG, Brasil
Country
Brazil
Secondary sponsor category [1] 256371 0
None
Name [1] 256371 0
Address [1] 256371 0
Country [1] 256371 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 31265 0
Address 31265 0
Country 31265 0
Phone 31265 0
Fax 31265 0
Email 31265 0
Contact person for public queries
Name 14512 0
Ana Cristina Rodrigues Lacerda
Address 14512 0
Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM) - Healthy and Biological Sciences Faculty - Exercise Physiology Laboratory, Glorias's street, nº 187, Centro, 39100-000, Diamantina, MG,
Country 14512 0
Brazil
Phone 14512 0
+55038/35321239
Fax 14512 0
Email 14512 0
[email protected]
Contact person for scientific queries
Name 5440 0
Ana Cristina Rodrigues Lacerda
Address 5440 0
Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM) - Healthy and Biological Sciences Faculty - Exercise Physiology Laboratory, Glorias's street, nº 187, Centro, 39100-000, Diamantina, MG,
Country 5440 0
Brazil
Phone 5440 0
+55038/35321239
Fax 5440 0
Email 5440 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.