Condition category
Surgery
Date applied
20/11/2015
Date assigned
03/03/2016
Last edited
12/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Public

Primary contact

Dr Neil Artz

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

North Bristol NHS Trust (UK)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

2016 results in: http://cre.sagepub.com/content/early/2016/04/08/0269215516642503.full

Publication citations

Additional files

Editorial Notes

12/04/2016: Publication reference added.