Condition category
Surgery
Date applied
20/10/2014
Date assigned
25/02/2015
Last edited
16/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Pedometers are portable devices, often attached by a belt worn on the waist. That counts every step a person takes by detecting hip movements. There is evidence to suggest that these devices promote physical activity and improve quality of life in the general population. It is also suggested that people generally don’t increase their physical activity levels after undergoing hip replacement surgery. Here, we hope to use the pedometer to increase levels of physical activity in this group of patients and help them to recover from their surgery.

Who can participate?
Adults (at least 18 years old) who have a hip replacement operation scheduled for 2 weeks’ time or later and are able to walk at least 10m without walking aids.

What does the study involve?
The participants are randomly allocated into one of two groups. Those in group 1 receive standard care following their surgery. Those in group 2 receive standard care and a pedometer-driven
walking intervention (treatment). Each person in this group will be given a target number of steps to walk each week using their pedometer.

What are the possible benefits and risks of participating?
The possible benefits of taking part in the study are that it is helping to understand if physical activity aids recovery following hip replacement. The additional risks on taking part in this study is that there is a slight increase in the risk of suffering a ‘sports injury’ as it is likely that participation in this study will result in participants being more physically active than usual.

Where is the study run from?
University of East Anglia (UK)

When is the study starting and how long is it expected to run for?
November 2014 to September 2016

Who is funding the study?
University of East Anglia (UK)

Who is the main contact?
Mr Tom Withers
t.withers@uea.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mr Tom Withers

ORCID ID

http://orcid.org/0000-0002-5286-7189

Contact details

Room 1.23
School of Health Sciences
Queen's Building
University of East Anglia
Norwich
NR4 7TJ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

What is the effect on independent recovery of using pedometers as a tool to prescribe exercise following total hip replacement? A two arm randomised controlled trial

Acronym

HPA

Study hypothesis

1. Prescribed PA will significantly increase the overall amount of PA undertaken.
2. Prescribed PA will significantly improve quality of life.

Ethics approval

Cambridge south ethics committee, 20/10/2014, ref. 14/EE/1178

Study design

Two arm randomised controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

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 hip arthroplasty.

Intervention

Participants are randomly allocated into one of two groups.
Group 1: Receive standard care
Group 2: Receive standard care and walking based pedometer intervention

Intervention type

Phase

Not Applicable

Drug names

Primary outcome measures

Oxford Hip Score

Measured pre-surgery and 4, 12 and 24 weeks post surgery.

Secondary outcome measures

1. Hip dislocation
2. Quality of life measured by self-completed questionnaire
3. Physical activity level through accelerometry.

Measured pre-surgery and 4, 12 and 24 weeks post surgery.

Overall trial start date

01/11/2014

Overall trial end date

30/09/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patient is on the waiting list for primary elective unilateral THR
2. Patient is 18 years of age or older
3. Patient is able to walk at least 10m pre-operation without walking aids, if the patient is unable to walk pre-operation it is believed that the patient will be able to walk post-THR
4. Patients operation is scheduled to be at least 2 weeks away
5. Patients have no other prosthetic implants
6. The surgeon that is performing the operation performs operations in both the independent and NHS hospital

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

160

Participant exclusion criteria

1. Patient is unable to give informed consent
2. Patient is having two different procedures combined together in one operation
3. Patients cannot comprehend English and do not have a friend, relative or care giver who is willing to translate for them
4. Patient is currently undertaking a custodial sentence
5. Patient already has a prosthetic hip in the other femur or patient is undergoing replacement of a previously implanted prosthetic hip
6. If the participants suffer an operative or perioperative complication they will be excluded from the study at this stage
7. Participants who suffer from any absolute or relative contraindication to exercise
8. For this this study partial proximal femur resection (PFR) will not be considered a form of THR
9. Patient lives in a care home
10. A reason for the patients to undergo THR is due to a form of cancer

Recruitment start date

05/12/2014

Recruitment end date

31/03/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of East Anglia
Room 1.23 School of Health Sciences Queen's Building
Norwich
NR4 7TJ
United Kingdom

Sponsor information

Organisation

University of East Anglia

Sponsor details

Research and Enterprise Services West Office
Norwich
NR4 7TJ
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

University of East Anglia

Alternative name(s)

UEA

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

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

Publication citations

Additional files

Editorial Notes

16/05/2016: Recruitment end date changed from 30/09/2016 to 31/03/2016