Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000311459
Ethics application status
Approved
Date submitted
6/06/2007
Date registered
13/06/2007
Date last updated
31/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A lifestyle intervention to improve function and health outcomes in older adults with knee osteoarthritis: A pilot study
Scientific title
A randomized control trial in older adults with osteoarthritis to determine the effectiveness of a group-based lifestyle intervention to promote modest weight loss compared with no intervention on improving health outcomes as determined by improvements in pain, function, quality of life and body composition.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 1853 0
Overweight/Obesity 1854 0
Condition category
Condition code
Musculoskeletal 1947 1947 0 0
Osteoarthritis
Diet and Nutrition 1948 1948 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention – 12-week lifestyle program which will (i) combine dietary modification and activity to achieve weight loss of at least 5% initial weight; (ii) use home-based training to comply with recommendations for exercise prescription in OA;(iii) include self efficacy, management and monitoring strategies and aspects of cognitive behaviour therapy to build capacity and confidence to make required lifestyle changes.
Intervention code [1] 1806 0
Lifestyle
Comparator / control treatment
Controls – Be placed on a waiting list for hospital-based group lifestyle intervention to commence post final assessment
Control group
Active

Outcomes
Primary outcome [1] 2766 0
Pain and Function (WOMAC)
Timepoint [1] 2766 0
Pre- and post-test, measured at baseline and week 12
Secondary outcome [1] 4661 0
% Body Fat; Weight; Quality of life; Pain and general self-efficacy; Timed Up and Go; Six minute walk; pre- and post-test.
Timepoint [1] 4661 0
Measured at baseline and week 12

Eligibility
Key inclusion criteria
BMI > 27 kg/m2; Meets American College Rheumatology criteria for knee OA; patients whose X-ray joint space >2 mm at the narrowest point of the medial compartment and/or < 2mm of lateral compartment of the signal joint; ambulatory, no use of a walker, braces or crutches.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Knee OA secondary to other bone or joint disease (permit secondary to knee trauma); the following procedures on the signal joint (i) < 3 months arthroscopy or intra-articular injections, (ii) < 2 years intra-articular surgery including trimming, (iii) <3 years for osteotomy; total menisectomy; chronic inflammatory joint disease including crystal arthropathies and OA of hip; planned knee replacement; any condition which will inhibit/contraindicate adherence to the diet and exercise program; participation in alternate formal exercise program; Mini-Mental score<24; Significant psychological distress or other barriers (eg frailty/illness) to effective participation, unable to understand study materials or complete questionnaires.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will occur post baseline measurement using sequentially numbered opaque sealed envelopes hled in a central location (holder of the envelopes independant of the research team).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer-generated randomisation schedule prepared by the ihbi Research Development and Support Group
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2091 0
Other
Name [1] 2091 0
Institute of Health and Biomedical Innovation
Country [1] 2091 0
Australia
Primary sponsor type
Individual
Name
Prof Lynne Daniels
Address
Country
Secondary sponsor category [1] 1895 0
Individual
Name [1] 1895 0
Assoc Prof Susan Ash
Address [1] 1895 0
Country [1] 1895 0
Secondary sponsor category [2] 1896 0
Individual
Name [2] 1896 0
Assoc Prof Kevin Tetsworth
Address [2] 1896 0
Country [2] 1896 0
Secondary sponsor category [3] 1897 0
Individual
Name [3] 1897 0
Ms Merrilyn Banks
Address [3] 1897 0
Country [3] 1897 0
Secondary sponsor category [4] 1898 0
Individual
Name [4] 1898 0
Ms Elaine Unkles
Address [4] 1898 0
Country [4] 1898 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3880 0
Royal Brisbane and Women's Hospital
Ethics committee address [1] 3880 0
Ethics committee country [1] 3880 0
Australia
Date submitted for ethics approval [1] 3880 0
Approval date [1] 3880 0
29/05/2007
Ethics approval number [1] 3880 0
2007/034
Ethics committee name [2] 3881 0
Queensland University of Technology
Ethics committee address [2] 3881 0
Ethics committee country [2] 3881 0
Australia
Date submitted for ethics approval [2] 3881 0
Approval date [2] 3881 0
05/06/2007
Ethics approval number [2] 3881 0
0700000220

Summary
Brief summary
This is a pilot project which aims to test the feasibility of a larger trial in this area. This project is designed as a pilot randomised trial (RCT) to evaluate a group-based nutrition and exercise weight loss program supported by standardized self-management education. It is hypothesised that promoting modest, realistic weight loss in overweight older adults with osteoarthritis (OA) of the knee will improve function and slow disease progression.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27909 0
Address 27909 0
Country 27909 0
Phone 27909 0
Fax 27909 0
Email 27909 0
Contact person for public queries
Name 10995 0
Professor Lynne Daniels
Address 10995 0
Institute of Health and Biomedical Innovation
Queensland University of Technology
60 Musk Ave
Kelvin Grove QLD 4059
Country 10995 0
Australia
Phone 10995 0
+61 7 31386139
Fax 10995 0
+61 7 31386030
Email 10995 0
[email protected]
Contact person for scientific queries
Name 1923 0
Professor Lynne Daniels
Address 1923 0
Institute of Health and Biomedical Innovation
Queensland University of Technology
60 Musk Ave
Kelvin Grove QLD 4059
Country 1923 0
Australia
Phone 1923 0
+61 7 31386139
Fax 1923 0
+61 7 31386030
Email 1923 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.