ARENA study: effectiveness and cost-effectiveness of outpatient physiotherapy after knee replacement
| ISRCTN | ISRCTN32087234 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32087234 |
| Secondary identifying numbers | 18286 |
- Submission date
- 11/02/2015
- Registration date
- 11/02/2015
- Last edited
- 01/08/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Knee replacement is a common operation for patients with osteoarthritis. It is a major operation with a long recovery period. Physiotherapy is an important part of the recovery process because it can help improve strength and movement in the replaced knee and allow people to gain the maximum benefit from the operation. However, not all hospitals offer physiotherapy to patients once they have been discharged after their knee replacement operation. In this study, we will find out whether it is helpful to offer exercise classes to patients following knee replacement.
Who can participate?
Adult (aged at least 18) NHS patients about to have a total knee replacement due to osteoarthritis at Southmead Hospital or Emersons Green Treatment Centre (UK).
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 receive usual care after their knee replacement where they are given a leaflet about exercise and referred to outpatient physiotherapy on a needs only basis i.e. if they have poor mobility. Those in group 2 are invited to attend an exercise class, in addition to receiving ‘usual care’. This class is run every week for six weeks, starting at six weeks after knee replacement surgery. In the class, patients practice task related exercises such as walking, stair climbing, and kneeling. Each patient is also given two individualised exercises, designed by the physiotherapist, to help address specific goals. We ask everyone in the study to complete questionnaires during the first year after surgery to see if the exercise classes improve their mobility. We also collect information to compare the cost of providing both treatments. The findings from this study will help us to know if providing outpatient exercises classes can improve patient’s mobility up to one year after knee replacement surgery and is good value for money to invest NHS resources.
What are the possible benefits and risks of participating?
Patients participating in the exercise class may gain some functional benefit from regular specific exercises. However we do not know whether the exercise class will provide any benefit over usual care
Risks include the physical risks of undertaking exercise. Many patients will continue to have some ongoing pain and functional limitations in the first 3 months after their knee replacement. Participation in the exercise class has the potential to cause further pain and tissue injury or exacerbate existing pain. Although these risks are likely to be small, every attempt to minimize these risks will made. Participants in the exercise class will be monitored throughout the duration of the class and all adverse events will be documented. All exercises will be demonstrated and participants will be advised on how to exercise safely. If the physiotherapists are concerned about a participant then they will contact the participant's consultant orthopaedic surgeon following discussion with the participant.
Where is the study run from?
Southmead Hospital and Emersons Green Treatment Centre (UK)
When is the study starting and how long is it expected to run for?
March 2015 to May 2018
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Vikki Wylde
v.wylde@bristol.ac.uk
Contact information
Scientific
Musculoskeletal Research Unit
University of Bristol
Level 1, Learning and Research Building
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
| Phone | +44 (0)117 4147878 |
|---|---|
| v.wylde@bristol.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Not specified |
|---|---|
| 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 contact details to request a patient information sheet |
| Scientific title | Effectiveness and cost-effectiveness of outpatient physiotherapy after knee replacement: a randomised controlled trial |
| Study acronym | ARENA |
| Study hypothesis | The aim of this study is to find out whether it is helpful to offer exercise classes to patients following knee replacement. |
| Ethics approval(s) | NRES Committee South West – Central Bristol, 19/01/2015, ref: 14/SW/1144 |
| Condition | Topic: Surgery; Subtopic: Surgery; Disease: All Surgery |
| Intervention | Outpatient physiotherapy: Six week group-based outpatient physiotherapy course consisting of task-related and individualised exercises, starting 6 weeks after total knee replacement surgery. |
| Intervention type | Other |
| Primary outcome measure | Lower Extremity Functional Scale (LEFs) at 12 months after surgery |
| Secondary outcome measures | 1. EQ-5D-5L at 2 weeks, 3 months, 6 months and 12 months after surgery 2. LEFS at 3 months and 6 months after surgery 3. Knee Injury and Osteoarthritis Outcome Score (KOOS) at 3 months, 6 months and 12 months after surgery 4. Self-Administered Patient Satisfaction Scale for Primary Hip and Knee Arthroplasty at 3 months, 6 months and 12 months after surgery 5. Likert-type scale for satisfaction with physiotherapy treatment received at 3 months, 6 months and 12 months after surgery 6. Hospital Anxiety and Depression Scale at 3 months, 6 months and 12 months after surgery |
| Overall study start date | 01/11/2014 |
| Overall study end date | 09/05/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 256; UK Sample Size: 256 |
| Total final enrolment | 180 |
| Participant inclusion criteria | 1. NHS patients listed for primary total knee replacement due to osteoarthritis at Southmead Hospital or Emersons Green Treatment Centre 2. Male & Female 3. Lower Age Limit 18 years |
| Participant exclusion criteria | 1. Patients listed for total knee replacement for reasons other than osteoarthritis 2. Patients listed for revision total knee replacement 3. Patients unable or unwilling to attend physiotherapy classes if randomised to the intervention group 4. Inability to participate in exercise for medical reasons such as unstable cardiovascular or severe neurological conditions 5. Unable or unwilling to provide informed consent 6. Inability to understand English because not all the questionnaires have been translated and validated into other languages 7. Post-operative complication(s) within the first two weeks of surgery which would preclude participation in the physiotherapy class e.g. prosthetic joint infection, manipulation under anaesthetic |
| Recruitment start date | 01/03/2015 |
| Recruitment end date | 01/03/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Westbury-On-Trym
Bristol
BS10 5NB
United Kingdom
Emersons Green
Bristol
BS16 7FH
United Kingdom
Sponsor information
Hospital/treatment centre
Research & Innovation
Floor 3 Learning & Research Building
Southmead Hospital
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 | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | The trial protocol will be submitted for publication in an open-access journal by Spring 2015. After the trial is complete, manuscripts presenting the clinical and cost-effectiveness results will be submitted to relevant peer-review journals. Results will also be submitted for presentation at a national or international conference. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publically available repository, the University of Bristol Research Data Repository (https://data.bris.ac.uk/data/). Data will be available 6 months following publication. Access to the data will be restricted to ensure that data is only made available to bona fide researchers for ethically approved research projects, on the understanding that confidentiality will be maintained and after a Data Access Agreement has been signed by an institutional signatory. Consent from participants was obtained for sharing of anonymised data. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 13/06/2016 | Yes | No | |
| Results article | results | 01/06/2020 | 01/08/2019 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
01/08/2019: Publication reference and total final enrolment number added, contact details updated.
12/12/2018: The overall trial end date was changed from 31/12/2017 to 09/05/2018.
20/12/2016: The recruitment end date has been updated from 01/06/2016 to 01/03/2017 and the study contact has been changed from Nabeela Iqbal to Kristina Lewis.
14/06/2016: Publication reference added.
