Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000751077
Ethics application status
Approved
Date submitted
3/07/2009
Date registered
9/09/2010
Date last updated
9/09/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Action and coping plans as strategies to improve adherence to exercise programmes for osteoarthritis of the hip and knee.
Scientific title
Action and coping plans as strategies to improve adherence to exercise programmes for osteoarthritis of the hip and knee.
Secondary ID [1] 252662 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 237150 0
Condition category
Condition code
Musculoskeletal 237476 237476 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12 week exercise programme with action and coping plans. The exercise programme consists of general strnegthening and mobility exercises done at the departmental gymnasium, and a brisk walking done at home. The gym sessions are one hour in duration two to three times per week, and the walking is done two to three times per week for about 30 minutes. The action plans involve the patient indicating when, where, and how they will undertake their gym exercise sessions and the whe, where, how and with whom they undertake the walking. The coping plans are based on the participants indicating the barriers/obstacles they predict may hinder their participation in the exercise programme, and how they may overcome them. Participants are given a written record of their action and coping plans to refer to throughout their time on the exercise programme.
Intervention code [1] 236864 0
Rehabilitation
Comparator / control treatment
12 week exercise programme with action and coping plans. The exercise programme consists of general strnegthening and mobility exercises done at the departmental gymnasium, and a brisk walking done at home. The gym sessions are one hour in duration two to three times per week, and the walking is done two to three times per week for about 30 minutes.
Control group
Active

Outcomes
Primary outcome [1] 238277 0
Actual and perceived performance function as measured by timed up and go test, 10-metre walk test, Hill's step test, six minute walk test, and the Lower Limb Task Questionnaire
Timepoint [1] 238277 0
baseline and 12 weeks
Primary outcome [2] 238278 0
Adherence to the exercise programme will be measured by percentage of class atendance, completion rate of the entire exercise programme, and adherence to the gym based exercise programme and the home-based exercise programme.
Timepoint [2] 238278 0
At each gym based exercise session
Primary outcome [3] 238279 0
Self-efficacy will be measured by task, maintencance and recovery self-efficacy and the self-efficacy scale for arthritis. These are self-report questionnaires.
Timepoint [3] 238279 0
baseline and 12 weeks.
Secondary outcome [1] 244653 0
Pain will be measured by the visual analogue scale.
Timepoint [1] 244653 0
baseline and 12 weeks
Secondary outcome [2] 244654 0
Demographic and disease characteristics will be measured by a self-report questionnaire.
Timepoint [2] 244654 0
Baseline

Eligibility
Key inclusion criteria
Osteoarthritis of hip and knee as confirmed by a physician, the diagnosis must meet the American college of Rheumatology and have radiological evidence.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Has a poor command of the English language, currently receiving physiotherapy, unable to perform exercises because of other health disorders.

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)
Participants will be recruited through advertisements, retirement complexes, bowling clubs, AUT University clinic and physiotherapy clinics. Participant number will be allocated by order of enrolment in the study by a blinded research assistant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated randomisation table will be used for group allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 1868 0
New Zealand
State/province [1] 1868 0

Funding & Sponsors
Funding source category [1] 237250 0
Other
Name [1] 237250 0
New Zealand Manipulative Physiotherapists' Association
Country [1] 237250 0
New Zealand
Primary sponsor type
University
Name
AUT University
Address
Private Bag 92006,
Auckland, 1142
Country
New Zealand
Secondary sponsor category [1] 236736 0
None
Name [1] 236736 0
Address [1] 236736 0
Country [1] 236736 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239351 0
Health and Disability Ethics Committees, Committee Y
Ethics committee address [1] 239351 0
Ethics committee country [1] 239351 0
New Zealand
Date submitted for ethics approval [1] 239351 0
28/11/2008
Approval date [1] 239351 0
08/04/2009
Ethics approval number [1] 239351 0
NTY/09/01/001

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

Contacts
Principal investigator
Name 29839 0
Address 29839 0
Country 29839 0
Phone 29839 0
Fax 29839 0
Email 29839 0
Contact person for public queries
Name 13086 0
Daniel O'Brien
Address 13086 0
Physiotherapy Clinic, Faculty of Health and Environmental Sciences, Private Bag 92006, Auckland, 1142.
Country 13086 0
New Zealand
Phone 13086 0
+6499219160
Fax 13086 0
+6499219620
Email 13086 0
[email protected]
Contact person for scientific queries
Name 4014 0
Dr Sandra F. Bassett
Address 4014 0
Department of Physiotherapy, School of Rehabilitation and Occupation Studies, Faculty of Health and Environmental Sciences, Private Bag 92006, Auckland, 1142.
Country 4014 0
New Zealand
Phone 4014 0
+6499219999 ext 7123
Fax 4014 0
+6499219620
Email 4014 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.