Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000230651
Ethics application status
Approved
Date submitted
25/08/2005
Date registered
26/08/2005
Date last updated
16/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Muscle Strength vs. Muscle Endurance Training for Osteoarthritis of the Knee in Older Adults; A double-blind, randomized sham exercise-controlled trial
Scientific title
A double-blinded randomised clinical trial to evaluate the effects of muscle strength training, or muscle endurance training compared with sham exercise training in the treatment of osteoarthritic-related pain.
Secondary ID [1] 124 0
GETSET
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritic-related pain 316 0
Condition category
Condition code
Musculoskeletal 360 360 0 0
Osteoarthritis
Alternative and Complementary Medicine 361 361 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients were randomised to one of the following for 8 weeks: 1) Endurance training group, 2) Strength training group
Intervention code [1] 253 0
None
Comparator / control treatment
Unweighted control group (sham exercise).
Control group
Placebo

Outcomes
Primary outcome [1] 420 0
WOMAC Osteoarthritis Index scores
Timepoint [1] 420 0
Measured at baseline and post-test (8 weeks)
Primary outcome [2] 421 0
VAS usual pain scores
Timepoint [2] 421 0
Measured at baseline and post-test (8 weeks)
Secondary outcome [1] 901 0
Isometric and dynamic maximal strength
Timepoint [1] 901 0
Measured at baseline and post-test (8 weeks).
Secondary outcome [2] 902 0
Habitual gait speed
Timepoint [2] 902 0
Measured at baseline and post-test (8 weeks).
Secondary outcome [3] 903 0
6minute walking distance
Timepoint [3] 903 0
Measured at baseline and post-test (8 weeks).
Secondary outcome [4] 904 0
Static balance
Timepoint [4] 904 0
Measured at baseline and post-test (8 weeks).
Secondary outcome [5] 905 0
EWART physical self-efficacy scores
Timepoint [5] 905 0
Measured at baseline and post-test (8 weeks).
Secondary outcome [6] 906 0
SF-36 Health Status scores
Timepoint [6] 906 0
Measured at baseline and post-test (8 weeks).

Eligibility
Key inclusion criteria
Primary (idiopathic) osteoarthritis of hip &/or knee identified using standard criteria of the American College of Rheumatology for classification of clinical osteoarthritis (pain of the knee or hip on most days of the past month, morning stiffness by history; crepitus, bony enlargement of the knee, pain or limitation of motion on internal rotation of the hip on exam, or radiographic evidence of osteophytes or joint space narrowing from medical record review). pain of at least mild intensity (>25 on a 100mm visual analog scale). Community-dwelling (living independently) ambulatory without human assistance. Willingness to be randomised to experimental or control groupsAbility to attend scheduled exercise and testing sessions.
Minimum age
50 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Regular exercise of any kind over the past 6 months (1dpw). Secondary osteoarthritis (traumatic or post-surgical), rheumatic disease, gouty or septic arthritis, Paget's disease, pseudogout, major congenital abnormalities, hemachromatosis, Wilson's disease and other rare forms of arthritis Joint injury, injection or surgery within the past 6 months or joint replacement. Acute or terminal illness. Unstable systemic disease precluding exercise such asAcute myocardial infarction in the past 6 months. Unstable cardiovascular disease (angina, cardiac arrhythmias, hypertension). Uncontrolled diabetes or other metabolic disease.Disorders of the nervous system disrupting voluntary movement (cerebrovascular accident/stroke with residual paresis, Parkinson's disease, demyelination disorders - multiple sclerosis). Severe functional limitation (unable to walk unaided). Musculoskeletal disease/injury severely restricting voluntary movement. (severe arthritis/ankylosis, pain related to osteoporotic vertebral crush fractures, rotator cuff disease/injury). Cognitive impairment Other contra-indication to exercise as assessed during the screening history and physical examination by a study physician.

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)
Yes. Sealed, opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Yes. Permuted blocks by gender. Assignments will be enclosed in sealed, opaque envelopes in bundles of males and females. To improve assignment acceptance, subjects will select and open an envelope from the stack of their gender. (Blue for Males, Pink for females)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 420 0
Government body
Name [1] 420 0
Commonwealth of Australia, Department of Health and Ageing
Country [1] 420 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 339 0
None
Name [1] 339 0
None
Address [1] 339 0
Country [1] 339 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36043 0
Address 36043 0
Country 36043 0
Phone 36043 0
Fax 36043 0
Email 36043 0
Contact person for public queries
Name 9442 0
Maria Fiatarone Singh
Address 9442 0
John Sutton Chair of Exercise and Sport Science
School of Exercise and Sport Science
Professor of Medicine
Faculty of Health Sciences
University of Sydney
Cumberland Campus
East Street
Lidcombe NSW 2141
Country 9442 0
Australia
Phone 9442 0
+61 2 93519755
Fax 9442 0
+61 2 93519204
Email 9442 0
m.singh@fhs.usyd.edu.au
Contact person for scientific queries
Name 370 0
Maria Fiatarone Singh
Address 370 0
John Sutton Chair of Exercise and Sport Science
School of Exercise and Sport Science
Professor of Medicine
Faculty of Health Sciences
University of Sydney
Cumberland Campus
East Street
Lidcombe NSW 2141
Country 370 0
Australia
Phone 370 0
+61 2 93519755
Fax 370 0
+61 2 93519204
Email 370 0
m.singh@fhs.usyd.edu.au

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.