Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000595819
Ethics application status
Approved
Date submitted
1/06/2012
Date registered
1/06/2012
Date last updated
9/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of physiotherapy booster sessions on home exercise outcomes in people with knee osteoarthritis
Scientific title
Effects of limited physiotherapy booster sessions on pain and function outcomes with home exercise in people with knee osteoarthritis
Secondary ID [1] 280596 0
Nil
Universal Trial Number (UTN)
U1111-1131-3821
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 286600 0
Condition category
Condition code
Musculoskeletal 286875 286875 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 286888 286888 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prior to entering this trial, participants will have visited a physiotherapist on 14 occasions to be taught home exercises - either a neuromuscular exercise program that focused on functional exercise and balance/co-ordination and included six exercises or a quadriceps strengthening program that comprised five exercises. During this trial, participants will be asked to continue with their home exercise program three times per week (approx 30 minutes per session) for 24 weeks. An exercise log book will be provided to participants with encouragement to record exercise sessions to assist with motivation. However, this will be an optional self monitoring tool. Participants will additionally receive two 30-minute booster physiotherapy exercise sessions at weeks 8 and 16 at the physiotherapists' clinic. At these visits, the physiotherapist will review the exercises and discuss progress with the participant. Discussion will also focus on barriers to home exercise performance and strategies to enhance adherence.
Intervention code [1] 284987 0
Rehabilitation
Comparator / control treatment
The control group will be asked to perform the same home exercises three times per week but will not receive the two physiotherapy booster sessions
Control group
Active

Outcomes
Primary outcome [1] 287235 0
Average overall knee pain during the past week using 100 mm visual analogue scale with terminal descriptors of no pain and worst pain possible
Timepoint [1] 287235 0
Baseline and 24 weeks
Primary outcome [2] 287236 0
Self reported physical function using the disease-specific Western Ontario McMaster Universities (WOMAC) Osteoarthritis Index. The physical function subscale comprises 17 questions in a Likert format
Timepoint [2] 287236 0
Baseline and 24 weeks
Secondary outcome [1] 297688 0
Average pain on walking during the past week assessed using 100 mm visual analogue scale with terminal descriptors of no pain and worst pain possible.
Timepoint [1] 297688 0
Baseline and 24 weeks
Secondary outcome [2] 297689 0
Pain subscale of the disease-specific Western Ontario McMaster Universities (WOMAC) Osteoarthritis Index
Timepoint [2] 297689 0
Baseline and 24 weeks
Secondary outcome [3] 297694 0
Perceived a) overall change, as well as change in b) pain and in c) physical function (compared to baseline) on a seven-point ordinal scale (1-much worse to 7-much better)
Timepoint [3] 297694 0
24 weeks
Secondary outcome [4] 297695 0
Health-related quality of life will be measured using the Assessment of Quality of Life instrument version two (AQoL II).
Timepoint [4] 297695 0
Baseline and 24 weeks
Secondary outcome [5] 297696 0
Habitual physical activity will be measured using the Physical Activity Scale for the Elderly (PASE), a self-report questionnaire which records both the level and type of recreational and occupational physical activity undertaken by participants over the previous week.
Timepoint [5] 297696 0
Baseline and 24 weeks
Secondary outcome [6] 297697 0
Adherence: The number of physiotherapy sessions attended will be recorded.
Timepoint [6] 297697 0
24 weeks
Secondary outcome [7] 297698 0
Adherence: to the home exercise program will be measured by asking participants via telephone, how many times they completed the home exercises in the previous week.
Timepoint [7] 297698 0
Weeks 7 and 15
Secondary outcome [8] 297699 0
Adherence to home exercise: participants will self-rate their adherence to the prescribed home exercise program using an 11-point numeric rating scale
Timepoint [8] 297699 0
Baseline and 24 weeks
Secondary outcome [9] 297786 0
Arthritis self efficacy scale
Timepoint [9] 297786 0
Baseline and 24 weeks
Secondary outcome [10] 297787 0
Pain catastrophising scale
Timepoint [10] 297787 0
Baseline and 24 weeks
Secondary outcome [11] 297788 0
Arthritis impact measurement scale
Timepoint [11] 297788 0
Baseline and 24 weeks
Secondary outcome [12] 297789 0
Coping strategies questionnaire
Timepoint [12] 297789 0
Baseline and 24 weeks
Secondary outcome [13] 297790 0
Adverse events such as increased pain from exercise and co-interventions - specially designed questionnaire
Timepoint [13] 297790 0
24 weeks

Eligibility
Key inclusion criteria
All participants who completed a clinical trial comparing the effects of a 12-week physiotherapist-supervised exercise program plus home exercises (either neuromuscular exercise or strengthening exercise) will be recruited (ACTRN12610000660088):
People were eligible for the feeder trial if they reported average knee pain over the past week greater than or equal to 25 on a 100 mm visual analogue scale, had predominant pain/tenderness over the medial knee region, and had radiographic evidence of medial tibiofemoral joint OA with varus knee alignment
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) knee surgery or intra-articular corticosteroid injection within past six months; (ii) current or past (within four weeks) oral corticosteroid use; (iii) systemic arthritic conditions; (iv) history of hip or knee joint replacement or tibial osteotomy surgery; (v) any other condition affecting lower limb function; (vi) participation in a strengthening or neuromuscular exercise program within the past six months or planning to commence exercise or other treatment for knee OA; (vii) other non-pharmacological treatment for their knee pain in the past six months including physiotherapy, acupuncture, massage therapy; or (viii) unable to ambulate without a gait aid.

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)
Consecutively numbered, sealed, opaque envelopes containing group allocation will be prepared by a researcher with no other involvement in the study. Allocation will be revealed by a person not involved in recruitment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A person not involved with the study generated the sequence a priori using the random number function in Excel. It involved
random permuted blocks according to the type of exercise (neuromuscular or strengthening) performed in the feeder trial.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/11/2011
Actual
18/11/2011
Date of last participant enrolment
Anticipated
Actual
21/09/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
78
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285354 0
Government body
Name [1] 285354 0
National Health and Medical Research Council
Country [1] 285354 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Parkville
Vic 3010
Country
Australia
Secondary sponsor category [1] 284203 0
None
Name [1] 284203 0
Address [1] 284203 0
Country [1] 284203 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287368 0
Human Research Ethics Committee University of Melbourne
Ethics committee address [1] 287368 0
Ethics committee country [1] 287368 0
Australia
Date submitted for ethics approval [1] 287368 0
Approval date [1] 287368 0
16/04/2010
Ethics approval number [1] 287368 0
0932813.1

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

Contacts
Principal investigator
Name 34248 0
Prof Kim Bennell
Address 34248 0
Department of Physiotherapy University of Melbourne Parkville Vic 3010
Country 34248 0
Australia
Phone 34248 0
+61 3 83444135
Fax 34248 0
Email 34248 0
[email protected]
Contact person for public queries
Name 17495 0
Professor Kim Bennell
Address 17495 0
Department of Physiotherapy
University of Melbourne
Parkville
Vic 3010
Country 17495 0
Australia
Phone 17495 0
+61 3 83444135
Fax 17495 0
Email 17495 0
[email protected]
Contact person for scientific queries
Name 8423 0
Professor Kim Bennell
Address 8423 0
Department of Physiotherapy
University of Melbourne
Parkville
Vic 3010
Country 8423 0
Australia
Phone 8423 0
+61 3 83444135
Fax 8423 0
Email 8423 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.