Optimising patient function following elective Total Hip Replacement (THR) surgery

ISRCTN	ISRCTN13019951
DOI	https://doi.org/10.1186/ISRCTN13019951
Protocol serial number	09/WNo01/52
Sponsor	Bangor University (UK)
Funder	North Wales Research Committee (UK)

Submission date: 21/02/2011
Registration date: 13/05/2011
Last edited: 04/05/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Tosan Okoro
Scientific

School of Medical Sciences
Brigantia Building
Bangor University
Bangor
LL57 2AS
United Kingdom

Study information

Primary study design	Interventional
Study design	Prospective single-blind randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The effect of resisted muscle strengthening exercises on patient function following elective Total Hip Replacement (THR) surgery: a prospective, single blind, randomised, controlled trial
Study acronym	THR Exercise Study
Study objectives	A home based, largely unsupervised resistance training programme after total hip replacement surgery improves patient function relative to standard physiotherapy
Ethics approval(s)	North West Wales Research Ethics committee, 14/01/2010
Health condition(s) or problem(s) studied	Rehabilitation after total hip replacement
Intervention	1. Patients will be randomised to either be in the control group (standard rehabilitation regime) or the intervention group 2. All patients in either group will have assessments pre-operatively and post operatively at 6 weeks, 3 months, 6 months and 1 year 3. The control group will receive routine inpatient and outpatient physiotherapy with the appropriate standard information leaflets provided 4. The intervention group will be shown the training exercises in the pre-assessment clinic and given information sheets 5. On post-operative day 2 (allowing for complications), these exercises will again be shown to them by an experienced physiotherapist 6. On discharge home, they will be seen by a qualified physiotherapist and the program will be adapted to their home environment 7. They will then be reviewed on a weekly basis for 6 weeks where the exercises shall be reviewed and resistance increased
Intervention type	Behavioural
Primary outcome measure(s)	1. Objective measures of physical function (related to activities of daily living): 1.1. Timed up and go test 1.2. Six minute walk test 1.3. Gait speed, stair climbing performance, and sit to stand score 1.4. Maximal voluntary contraction of quadriceps muscle and hip abductors The outcomes will be measured pre-operatively and post-operatively at 6 weeks, 6 months and 1 year
Key secondary outcome measure(s)	1. Subjective measures of physical function (Oxford Hip Score (OHS) and Western Ontario and McMasters University Osteoarthitis Personal Function (WOMAC PF) subscale 2. Short questionnaire to assess health enhancing physical activity (SQUASH) 3. EuroQoL Quality of life index 4. Objective assessment of physical activity (pedometers for 3 days to assess activity pre-operatively and during the intervention) as well as clinical assessment 5. Recovery locus of control questionnaire, theory of planned behaviour questionnaire, modified zung depression index and modified somatic perception questionnaire will be used to assess motivation to exercise, mood, and perceptions in the recruited population The outcomes will be measured pre-operatively and post-operatively at 6 weeks, 6 months and 1 year
Completion date	31/03/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	50
Key inclusion criteria	1. Patients undergoing primary total hip arthroplasty via a posterior approach which can either be cemented or uncemented 2. The joint affected should be the only severely arthritic joint, with no evidence of inflammatory arthropathy 3. Patient agreement to inclusion is also necessary
Key exclusion criteria	1. Dementia, or neurological impairment 2. Presence of cancer or muscle wasting illness, severe musculoskeletal impairment, unstable chronic or terminal illness, major depression, and co-morbid disease that contraindicates resistance training
Date of first enrolment	01/03/2010
Date of final enrolment	31/03/2012

Locations

Countries of recruitment

United Kingdom
Wales

Study participating centre

Bangor University

Bangor
LL57 2AS
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	21/04/2016		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

04/05/2016: Publication reference added.