Plain English Summary
Background and study aims
Total knee replacement (TKR) is a common operation in the UK for osteoarthritis of the knee. It involves replacing a damaged, worn or diseased knee with an artificial joint. Despite good pain relief after surgery, many patients continue to have ongoing functional difficulties that could be helped by exercise. The aim of this study is to determine whether a study comparing a physiotherapy exercise class with usual care could be carried at the Avon Orthopaedic Centre.
Who can participate?
Patients awaiting total knee replacement for osteoarthritis of the knee.
What does the study involve?
Participants are randomly allocated to receive either usual care or to attend a 6-week physiotherapy exercise class. Both groups complete questionnaires before surgery and at 2 weeks, 3 and 6 months after surgery. The rate of participant uptake, reasons for non-attendance at classes, patient satisfaction with the classes, patient-reported outcomes, timing and suitability of the exercises are recorded. The study also tests the methods to collect data for the cost analysis to assist in the development of a larger study.
What are the possible benefits and risks of participating?
Potential benefits of the group exercise class are increased knee function and activity participation and reduced pain. Potential risks of participating in the group exercise class include increased knee pain, although this was minimised by close supervision of exercise by two chartered physiotherapists.
Where is the study run from?
Southmead Hospital (UK)
When is the study starting and how long is it expected to run for?
October 2011 to February 2013
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Neil Artz
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Activity orientated rehabilitation following knee arthroplasty (ARENA): feasibility randomised control trial
Acronym
Study hypothesis
Investigate the feasibility of conducting a randomised controlled trial comparing group-based outpatient physiotherapy with usual care after total knee replacement
Ethics approval
South West – Cornwall and Plymouth Research Ethical Committee, 21/12/2011, ref: 11/SW/0341
Study design
Feasibility randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Total knee replacement for osteoarthritis
Intervention
Intervention group participate in a 6 week group-based functional and tailored exercise class starting at 6 weeks after surgery. Group-based physiotherapy exercise intervention will include six one-hour group exercise sessions for a duration of six weeks. Within this group, patients will also be provided with individual exercises targeted at individual functional goals.
Control group receive the usual care provided by the hospital after total knee replacement. Usual care given will be a knee replacement booklet given out at a pre-education class and contains information about discharge planning, the pre-operative period, the operation day, early and later stage post-operative exercises, performing everyday functional activities, returning to work and hobbies, discharge goals, precautions, expectations and potential problems.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
As this is a feasibility RCT there were no primary outcome measures as such.
1. Rate of participant uptake
2. Reasons for non-attendance at classes
3. Patient satisfaction with the classes
4. Timing and suitability of the exercises
Secondary outcome measures
Patient-reported outcomes including:
1. KOOS = Knee Injury and Osteoarthritis Outcome Score – pre-op, 2 weeks, 3 months and 6 months post-op
2. LEFS = lower extremity functional scale - 2 weeks, 3 months and 6 months post-op
3. ABC scale = activities-specific balance confidence scale - pre-op, 2 weeks, 3 months and 6 months post-op
4. Pain VAS = pain visual analogue scale - pre-op, 2 weeks, 3 months and 6 months post-op
5. UCLA = UCLA activity score - pre-op, 2 weeks, 3 months and 6 months post-op
6. SER = self-efficacy for rehabilitation - pre-op, 2 weeks, 3 months and 6 months post-op
7. Ab-IAP = Aberdeen Measures of Impairment, Activity Limitation and Participation Restriction - pre-op, 2 weeks, 3 months and 6 months post-op
8. MYMOP = Measure Yourself Medical Outcome Profile – 6 weeks, 3 months and 6 months post-op
Overall trial start date
05/10/2011
Overall trial end date
13/02/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients listed for total knee replacement for osteoarthritis
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
46
Participant exclusion criteria
1. Knee replacement for conditions other than osteoarthritis
2. Revision knee surgery
3. Inability to participate in exercise for any medical reason such as unstable cardiovascular or cardio-respiratory disease
4. Diagnosis of severe neurological disorders
5. Inability to provide informed consent
6. Inability to complete study questionnaires in the English language, as the study was using measures that had not all been validated in other languages
Recruitment start date
23/07/2012
Recruitment end date
13/02/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Southmead Hospital
BS10 5NB
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The results of the feasibility study have been submitted for publication and the manuscript is under review.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list
2016 results in: http://cre.sagepub.com/content/early/2016/04/08/0269215516642503.full