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Pedometer Based Intervention After Total Hip Replacement-A Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01972594
Recruitment Status : Completed
First Posted : October 30, 2013
Last Update Posted : March 13, 2015
Golden Jubilee National Hospital
Information provided by (Responsible Party):
Ben Stansfield, Glasgow Caledonian University

Brief Summary:
Total hip replacement is designed to alleviate pain, reduce disability and improve function and physical activity levels. Whilst pain, disability and function are often measured following surgery, actual physical activity is not. The aim of rehabilitation after total hip replacement would be to obtain optimal strength and range of movement at the hip along with cumulative endurance and balance. It is taken for granted that, once function is restored, the patient returns to physical activity levels associated with good health. In a previous study conducted by the same team it was observed that patients, at the end of 3 months after hip surgery, do not reach the levels of physical activity which are proven to be beneficial for health. Physiotherapy plays an important role in improving function and increasing levels of Physical activity in total hip replacement patients, but there is limited literature to substantiate this claim. There is a need to enhance levels of physical activity in patient after total hip replacement towards levels that are associated with good health. This study aims to demonstrate a method of enhancing physical activity levels after total hip replacement using a pedometer based intervention over a period of 3 months. Patients will follow a customized progressive stepping activity schedule aimed at establishing levels of physical activity that are associated with good health. To fully understand recovery patterns subjective and objective measures of strength of the hip muscles, range of motion at the hip, overall endurance, balance and speed of walking of the patient will be assessed. Questionnaires will be utilized to assess quality of life both before and after total hip surgery. The physical activity levels of the patient will be measured with a physical activity monitor. This study will be completed at the Golden Jubilee National Hospital at Glasgow.

Condition or disease Intervention/treatment Phase
Osteoarthritis of Hip Procedure: Targetted protocol with pedometer Device: Accelerometer(ActivPAL) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A 12 Week Pedometer Based Walking Intervention to Enhance Physical Activity Performance Following Total Hip Replacement-A Pilot Study
Study Start Date : January 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Arm Intervention/treatment
No Intervention: Control group.
Natural progession based on Step count is recorded with a pedometer for 12 weeks.
Experimental: Targeted protocol with Pedometer
A step based targeted protocol is given along with a pedometer for 12 weeks post surgery.
Procedure: Targetted protocol with pedometer
12 week protocol based on targetted steps are given to the patient along with a pedometer.

Device: Accelerometer(ActivPAL)

Primary Outcome Measures :
  1. Change in Physical Activity following Hip Replacement. [ Time Frame: pre-operative,Immediate post -operative,1st week post operative and 3 months post operative. ]
    Free-living physical activity performance will be recorded using an Accelerometer(ActivPAL).A small CE marked physical activity monitor, ActivPAL (PAL Technologies Ltd. Glasgow, UK) will be attached to the anterior thigh (of the non-operated leg) using a water proof surgical dressing material. This monitor, with proven validity is 50mm x 35mm x 7mm and weighs 30g. The fixing with the dressing allows it to be worn continually without affecting any patient activity such as washing / showering etc. This remains in place for the duration of the recording. It can record date for up to 7 days. The time spent upright, time spent stepping and the numbers of steps taken are recorded continuously over multiday periods. The intervention group will be encouraged to increase their physical activity levels. This will be based on a measure of stepping activity and a pedometer will act as a guideline for how many steps are required per day.

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Primary total hip replacement
  • Age group between 60-80 years old.
  • Able to give informed consent
  • Able to return for follow-up
  • Able to read and understand English and follow verbal and visual instructions

Exclusion Criteria:

Bilateral total hip replacements

  • Either hip or knee replacement in the last 12 months
  • Severe locomotor limitation due to cardio-respiratory dysfunction
  • Severe locomotor disorder due to central or peripheral nervous system deficits
  • Severe locomotor limitation due to spinal condition
  • Severe locomotor limitation due to musculoskeletal disabilities
  • Diagnosed terminal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01972594

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United Kingdom
Golden Jubilee National Hospital
Glasgow,Scotland, United Kingdom
Sponsors and Collaborators
Ben Stansfield
Golden Jubilee National Hospital
Additional Information:
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Responsible Party: Ben Stansfield, Academic Supervisor to the Chief Investigator of the Study, Glasgow Caledonian University Identifier: NCT01972594    
Other Study ID Numbers: GCU_ALARG_AJ_002
First Posted: October 30, 2013    Key Record Dates
Last Update Posted: March 13, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Osteoarthritis, Hip
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases