RT Journal Article
SR Electronic
T1 Home-based rehabilitation programme compared with traditional physiotherapy for patients at risk of poor outcome after knee arthroplasty: the CORKA randomised controlled trial
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e052598
DO 10.1136/bmjopen-2021-052598
VO 11
IS 8
A1 Karen L Barker
A1 Jonathan Room
A1 Ruth Knight
A1 Susan Dutton
A1 Francine Toye
A1 Jose Leal
A1 Nicola Kenealy
A1 Michael Maia Schlüssel
A1 Gary Collins
A1 David Beard
A1 Andrew James Price
A1 Martin Underwood
A1 Avril Drummond
A1 Sarah Lamb
A1 ,
YR 2021
UL http://bmjopen.bmj.com/content/11/8/e052598.abstract
AB Objectives To evaluate whether a home-based rehabilitation programme for people assessed as being at risk of a poor outcome after knee arthroplasty offers superior outcomes to traditional outpatient physiotherapy.Design A prospective, single-blind, two-arm randomised controlled superiority trial.Setting 14 National Health Service physiotherapy departments in the UK.Participants 621 participants identified at high risk of a poor outcome after knee arthroplasty using a bespoke screening tool.Interventions A multicomponent home-based rehabilitation programme delivered by rehabilitation assistants with supervision from qualified therapists versus usual care outpatient physiotherapy.Main outcome measures The primary outcome was the Late-Life Function and Disability Instrument (LLFDI) at 12 months. Secondary outcomes were the Oxford Knee Score (a disease-specific measure of function), Knee injury and Osteoarthritis Outcome Score Quality of Life subscale, Physical Activity Scale for the Elderly, 5 dimension, 5 level version of Euroqol (EQ-5D-5L) and physical function assessed using the Figure of 8 Walk test, 30 s Chair Stand Test and Single Leg Stance.Results 621 participants were randomised between March 2015 and January 2018. 309 were assigned to CORKA (Community Rehabilitation after Knee Arthroplasty) home-based rehabilitation, receiving a median five treatment sessions (IQR 4–7). 312 were assigned to usual care, receiving a median 4 sessions (IQR 2–6). The primary outcome, LLFDI function total score at 12 months, was collected for 279 participants (89%) in the home-based CORKA group and 287 participants (92%) in the usual care group. No clinically or statistically significant difference was found between the groups (intention-to-treat adjusted difference=0.49 points; 95% CI −0.89 to 1.88; p=0.48). There were no statistically significant differences between the groups on any of the patient-reported or physical secondary outcome measures at 6 or 12 months.There were 18 participants in the intervention group reporting a serious adverse event (5.8%), only one directly related to the intervention, all other adverse events recorded throughout the trial related to underlying chronic medical conditions.Conclusions The CORKA intervention was not superior to usual care. The trial detected no significant differences, clinical or statistical, between the two groups on either primary or secondary outcomes. CORKA offers an evaluation of an intervention utilising a different service delivery model for this patient group.Trial registration number ISRCTN13517704.Data are available upon reasonable request. Deidentified individual participant data will be available on reasonable request to the Chief Investigator. Data will be available beginning 9 months and ending 36 months following article publication to investigators who provide a methodologically sound proposal. Proposals may be submitted up to 36 months following article publication. To gain access data requestors will need to sign a data access agreement and the study in question.