ANZCTR - Registration

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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

Condition category

Condition code

Musculoskeletal

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]

Rehabilitation

Intervention code [2]

Other interventions

Comparator / control treatment

Uncontrolled

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

At baseline - the physiotherapy triage
Completion of 6 week exercise and weightloss program
3 & 12 months after exercise and weightloss program

Secondary outcome [1]

Patient specific functional scale questionairre

Timepoint [1]

At baseline - the physiotherapy triage
Completion of 6 week exercise and weightloss program
3 & 12 months after exercise and weightloss program

Secondary outcome [2]

Quality of Life Questionairre

Timepoint [2]

At baseline - the physiotherapy triage
Completion of 6 week exercise and weightloss program
3 & 12 months after exercise and weightloss program

Secondary outcome [3]

Lower limb strength : 30 second chair stand test

Timepoint [3]

At baseline - the physiotherapy triage
Completion of 6 week exercise and weightloss program
3 & 12 months after exercise and weightloss program

Secondary outcome [4]

Timed up and go which tests functional mobility

Timepoint [4]

At baseline - the physiotherapy triage
Completion of 6 week exercise and weightloss program
3 & 12 months after exercise and weightloss program

Secondary outcome [5]

Body mass assessed by scales

Timepoint [5]

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]

3199

Recruitment postcode(s) [2]

3939

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Australia

Primary sponsor type

Hospital

Name

Peninsula Health

Address

Hastings Road
Frankston
3199
VICTORIA

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Peninsula Health Human Research Ethics Committee

Ethics committee address [1]

Hastings Road
Frankston 3199
VICTORIA

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/06/2009

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Email

Contact person for public queries

Name

Alison Cotton

Address

Frankston Hospital
Hastings Road
Frankston 3199
VICTORIA

Country

Australia

Phone

+61 3 9784 7660

Fax

+61 3 9784 7661

Email

acotton@phcn.vic.gov.au

Contact person for scientific queries

Name

Alison Cotton

Address

Frankston Hospital
Hastings Road
Frankston 3199
VICTORIA

Country

Australia

Phone

+61 3 9784 7660

Fax

+61 3 9784 7661

Email

acotton@phcn.vic.gov.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.