Pedometer Based Intervention After Total Hip Replacement-A Pilot Study

This study is not yet open for participant recruitment.
Verified October 2013 by Glasgow Caledonian University
Sponsor:
Collaborator:
Golden Jubilee National Hospital
Information provided by (Responsible Party):
Ben Stansfield, Glasgow Caledonian University
ClinicalTrials.gov Identifier:
NCT01972594
First received: October 16, 2013
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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 Intervention
Osteoarthritis of Hip
Procedure: Targetted protocol with pedometer
Device: Accelerometer(ActivPAL)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Glasgow Caledonian University:

Primary Outcome Measures:
  • Change in Physical Activity following Hip Replacement. [ Time Frame: pre-operative,Immediate post -operative,1st week post operative and 3 months post operative. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: January 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01972594

Contacts
Contact: Artaban Johnson Jeldi, MSc 00441413313466 artaban.johnson@gcu.ac.uk
Contact: Angela H Deakin, PhD 00441419515000 Angela.Deakin@gjnh.scot.nhs.uk

Locations
United Kingdom
Golden Jubilee National Hospital Not yet recruiting
Glasgow,Scotland, United Kingdom
Contact: Catherine Sinclair, Phd    00441419515000    catherine.sinclair@gjnh.scot.nhs.uk   
Principal Investigator: David Allen         
Sponsors and Collaborators
Ben Stansfield
Golden Jubilee National Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Ben Stansfield, Academic Supervisor to the Chief Investigator of the Study, Glasgow Caledonian University
ClinicalTrials.gov Identifier: NCT01972594     History of Changes
Other Study ID Numbers: GCU_ALARG_AJ_002
Study First Received: October 16, 2013
Last Updated: October 24, 2013
Health Authority: R & D, Golden Jubilee National Hospital. NHS Scotland,United Kingdom:

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 16, 2014