Activity orientated rehabilitation following knee arthroplasty: feasibility study

ISRCTN ISRCTN13579789
DOI https://doi.org/10.1186/ISRCTN13579789
Secondary identifying numbers N/A
Submission date
20/11/2015
Registration date
03/03/2016
Last edited
12/04/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Neil Artz
Public

Institute of Sport and Exercise Science
University of Worcester
Henwick Road
St Johns
Worcester
WR2 6AJ
United Kingdom

Study information

Study designFeasibility randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleActivity orientated rehabilitation following knee arthroplasty (ARENA): feasibility randomised control trial
Study objectivesInvestigate the feasibility of conducting a randomised controlled trial comparing group-based outpatient physiotherapy with usual care after total knee replacement
Ethics approval(s)South West – Cornwall and Plymouth Research Ethical Committee, 21/12/2011, ref: 11/SW/0341
Health condition(s) or problem(s) studiedTotal knee replacement for osteoarthritis
InterventionIntervention 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 typeBehavioural
Primary outcome measureAs 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 measuresPatient-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 study start date05/10/2011
Completion date13/02/2013

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants46
Key inclusion criteriaPatients listed for total knee replacement for osteoarthritis
Key exclusion criteria1. 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
Date of first enrolment23/07/2012
Date of final enrolment13/02/2013

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Southmead Hospital
BS10 5NB
United Kingdom

Sponsor information

North Bristol NHS Trust (UK)
Hospital/treatment centre

Level 3
Learning and Research
Southmead Hospital
Southmead Road
Bristol
BS10 5NB
England
United Kingdom

ROR logo "ROR" https://ror.org/036x6gt55

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planThe results of the feasibility study have been submitted for publication and the manuscript is under review.
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 10/07/2016 Yes No

Editorial Notes

12/04/2016: Publication reference added.