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
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
Public
Institute of Sport and Exercise Science
University of Worcester
Henwick Road
St Johns
Worcester
WR2 6AJ
United Kingdom
Study information
| Study design | Feasibility randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Activity orientated rehabilitation following knee arthroplasty (ARENA): feasibility randomised control trial |
| Study objectives | Investigate 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) studied | 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 |
| 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 study start date | 05/10/2011 |
| Completion date | 13/02/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 46 |
| Key inclusion criteria | Patients listed for total knee replacement for osteoarthritis |
| Key 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 |
| Date of first enrolment | 23/07/2012 |
| Date of final enrolment | 13/02/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
United Kingdom
Sponsor information
Hospital/treatment centre
Level 3
Learning and Research
Southmead Hospital
Southmead Road
Bristol
BS10 5NB
England
United Kingdom
"ROR" |
https://ror.org/036x6gt55 |
|---|
Funders
Funder type
Government
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 share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The 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.
