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Trial registered on ANZCTR


Registration number
ACTRN12609000752268
Ethics application status
Not yet submitted
Date submitted
12/08/2009
Date registered
28/08/2009
Date last updated
28/08/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring the options : An investigation into the effectiveness of exercise and weightloss in modifying the symptoms of hip or knee arthritis and the need for surgery.
Scientific title
The effect of exercise and weight loss on pain, function and priority for surgery for persons with hip or knee arthritis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 243490 0
Condition category
Condition code
Musculoskeletal 239791 239791 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A tailored exercise program to suit your individual fitness level and needs. Your exercise class will be on two days per week with no more than 10 other patients with hip or knee arthritis in the group to physiotherapist. The session will last for 60 minutes held twice a week for 6 weeks and a physiotherapist/physiotherapy assistant will help you with your program.
Partipants will also receive advice and management regarding their weight from a dietician in a group setting. This will occur twice over the 6 week exercise period for a maximum period of 45 minutes.
Intervention code [1] 237110 0
Rehabilitation
Intervention code [2] 241120 0
Other interventions
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 240561 0
Multi Aptitude Priority Tool (MAPT) is an eleven item questionairre encompassing the domains of pain, function and psychosocial wellbeing. Questions are weighted and a mathematical equation gives a score out of a maximum 100 points (likelihood of disease consequences)
Timepoint [1] 240561 0
At baseline - the physiotherapy triage
Completion of 6 week exercise and weightloss program
3 & 12 months after exercise and weightloss program
Secondary outcome [1] 257153 0
Patient specific functional scale questionairre
Timepoint [1] 257153 0
At baseline - the physiotherapy triage
Completion of 6 week exercise and weightloss program
3 & 12 months after exercise and weightloss program
Secondary outcome [2] 257154 0
Quality of Life Questionairre
Timepoint [2] 257154 0
At baseline - the physiotherapy triage
Completion of 6 week exercise and weightloss program
3 & 12 months after exercise and weightloss program
Secondary outcome [3] 257155 0
Lower limb strength : 30 second chair stand test
Timepoint [3] 257155 0
At baseline - the physiotherapy triage
Completion of 6 week exercise and weightloss program
3 & 12 months after exercise and weightloss program
Secondary outcome [4] 257156 0
Timed up and go which tests functional mobility
Timepoint [4] 257156 0
At baseline - the physiotherapy triage
Completion of 6 week exercise and weightloss program
3 & 12 months after exercise and weightloss program
Secondary outcome [5] 257165 0
Body mass assessed by scales
Timepoint [5] 257165 0
Baseline, 3 months and 12 months after exercise and weightloss program

Eligibility
Key inclusion criteria
Likely to benefit from surgical therapy determined by their Multi-attribute Prioritisation Tool (MAPT) score < 75, have no contraindications to exercising, able to attend an exercise class and commit to a weight management program
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants where no benefits from physical therapies can be expected (MAPT score > 90), cognitive dysfunction, placement on waiting list from joint replacement surgery or scheduled joint replacement. Participants where no need for weight loss should occur (e.g. underweight body mass index (BMI) < 18.5)

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients are refered to the orthopaedic clinic for opinion regarding joint replacement surgery. Patients are offered an appointment with the physiotherapy triage for advise and treatment of their OA. Here they are offered to attend the trial
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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2009
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)
Recruitment postcode(s) [1] 2001 0
3199
Recruitment postcode(s) [2] 2002 0
3939

Funding & Sponsors
Funding source category [1] 237484 0
Self funded/Unfunded
Name [1] 237484 0
Country [1] 237484 0
Australia
Primary sponsor type
Hospital
Name
Peninsula Health
Address
Hastings Road
Frankston
3199
VICTORIA
Country
Australia
Secondary sponsor category [1] 236973 0
None
Name [1] 236973 0
Address [1] 236973 0
Country [1] 236973 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 239605 0
Peninsula Health Human Research Ethics Committee
Ethics committee address [1] 239605 0
Hastings Road
Frankston 3199
VICTORIA
Ethics committee country [1] 239605 0
Australia
Date submitted for ethics approval [1] 239605 0
05/06/2009
Approval date [1] 239605 0
Ethics approval number [1] 239605 0
2009-30

Summary
Brief summary
Osteoarthritis (OA) of the hip or knee is a common cause of pain and disability for many people. The symptoms may be progressive and may ultimately require joint replacement surgery. However, we know that some non-surgical treatment options in particular, exercise and weight loss, can alleviate the symptoms and possibly delay the progression of the disease but we don’t know to what extent this can occur. There are no studies that report whether the effect is ever sufficient to influence a patient’s need for surgery.
In this study we will identify patients with non-urgent hip or knee arthritis and invite them to participate in an intensive 6 week exercise and weight loss program at Frankston hospital. We will score their priority for surgery (using the MAPT tool which is validated for use in OA), record their self rated need for surgery and measure their body weight, pain, muscle strength, physical function and quality of life before and after the 6 week program. Data regarding priority for surgery, self rated need for surgery, and body weight will be collected at 3 and 12 months. We will also investigate any association between a number of patient related factors and the outcomes obtained. The aim of this study is to investigate the effect of an intensive program of exercise and weight loss for persons with hip or knee arthritis awaiting consideration of joint replacement surgery, on the pain and disability associated with hip or knee arthritis and priority for surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30033 0
Address 30033 0
Country 30033 0
Phone 30033 0
Fax 30033 0
Email 30033 0
Contact person for public queries
Name 13280 0
Alison Cotton
Address 13280 0
Frankston Hospital
Hastings Road
Frankston 3199
VICTORIA
Country 13280 0
Australia
Phone 13280 0
+61 3 9784 7660
Fax 13280 0
+61 3 9784 7661
Email 13280 0
[email protected]
Contact person for scientific queries
Name 4208 0
Alison Cotton
Address 4208 0
Frankston Hospital
Hastings Road
Frankston 3199
VICTORIA
Country 4208 0
Australia
Phone 4208 0
+61 3 9784 7660
Fax 4208 0
+61 3 9784 7661
Email 4208 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.