Condition category
Musculoskeletal Diseases
Date applied
21/02/2011
Date assigned
13/05/2011
Last edited
04/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Tosan Okoro

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

09/WNo01/52

Study information

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

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

North West Wales Research Ethics committee, 14/01/2010

Study design

Prospective single-blind randomised 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

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/03/2010

Overall trial end date

31/03/2012

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

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

Trial participating centre

Bangor University
Bangor
LL57 2AS
United Kingdom

Sponsor information

Organisation

Bangor University (UK)

Sponsor details

c/o Professor Michael Rees
School of Medical Sciences
Brigantia Building
Penrallt Road
Bangor
Bangor
LL57 2AS
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

North Wales Research Committee (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27097833

Publication citations

Additional files

Editorial Notes

04/05/2016: Publication reference added.