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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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24 May 2021 |
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Main ID: |
ISRCTN16250771 |
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Date of registration:
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25/02/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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What is the effect on independent recovery of using pedometers as a tool to prescribe exercise following total hip replacement?
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Scientific title:
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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 |
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Date of first enrolment:
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05/12/2014 |
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Target sample size:
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160 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN16250771 |
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Study type:
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Interventional |
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Study design:
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Two arm randomised controlled trial. (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Tom
Withers |
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Address:
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Room 1.23
School of Health Sciences
Queen's Building
University of East Anglia
NR4 7TJ
Norwich
United Kingdom |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Total hip arthroplasty.
Surgery
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Intervention(s)
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Participants are randomly allocated into one of two groups.
Group 1: Receive standard care
Group 2: Receive standard care and walking based pedometer intervention
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Primary Outcome(s)
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Oxford Hip Score
Measured pre-surgery and 4, 12 and 24 weeks post surgery.
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Secondary Outcome(s)
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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.
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Source(s) of Monetary Support
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University of East Anglia
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Ethics review
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Status:
Approval date:
Contact:
Cambridge south ethics committee, 20/10/2014, ref. 14/EE/1178
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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30/09/2016 |
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URL:
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