Optimising patient function following elective Total Hip Replacement (THR) surgery
| ISRCTN | ISRCTN13019951 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13019951 |
| Secondary identifying numbers | 09/WNo01/52 |
- 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
Not provided at time of registration
Contact information
Mr Tosan Okoro
Scientific
Scientific
School of Medical Sciences
Brigantia Building
Bangor University
Bangor
LL57 2AS
United Kingdom
Study information
| Study design | Prospective single-blind randomised 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 | 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 hypothesis | 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 |
| Condition | 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 | 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 |
| Secondary outcome measures | 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 |
| Overall study start date | 01/03/2010 |
| Overall study end date | 31/03/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 50 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/03/2010 |
| Recruitment end date | 31/03/2012 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Bangor University
Bangor
LL57 2AS
United Kingdom
LL57 2AS
United Kingdom
Sponsor information
Bangor University (UK)
University/education
University/education
c/o Professor Michael Rees
School of Medical Sciences
Brigantia Building
Penrallt Road
Bangor
Bangor
LL57 2AS
Wales
United Kingdom
"ROR" |
https://ror.org/006jb1a24 |
|---|
Funders
Funder type
Research organisation
North Wales Research Committee (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
04/05/2016: Publication reference added.
