Pedometer Based Intervention After Total Hip Replacement-A Pilot Study
Condition: Osteoarthritis of Hip
MeSH terms: Osteoarthritis, Hip
Study type: Interventional

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.
    

Detailed description: 
      Physical activity can be defined as the time spent engaging in non-sedentary behaviour. This
      would include sit to stand episodes, periods spent upright and periods spent stepping.
      Physical activity can be considered as purposeful free living activity with major health
      benefits. According to the World health organisation, Physical activity is defined as any
      bodily movement produced by skeletal muscles that requires energy expenditure. Physical
      inactivity has been identified as the fourth leading risk factor for global mortality causing
      an estimated 3.2 million deaths globally. Improvement in Physical activity levels has a
      direct and indirect add-on effect in reducing various comorbidities which may or may not
      exist in a patient including cardiac diseases, stroke, diabetes and osteoporosis. These facts
      can also be applied to orthopedically challenged individuals undergoing total hip replacement
      or recovering from it.

      Total hip replacement (THR) or total hip arthroplasty (THA) is one of the most common
      orthopaedic surgeries performed and has been termed as the "operation of the century". It has
      been suggested that impairment and physical limitations persisted in the long-term following
      a THR, even in the absence of pain, with reduced muscle strength, postural stability and
      flexibility. These factors would indirectly affect the physical activity levels of a patient
      which neutralizes one of the purposes of the total hip replacement. Reduction in the ability
      to be physically active is one of the reasons a patient undergoes a total hip replacement,
      others being pain and disability. One of the goals of the orthopaedic surgeon is to bring a
      patient back to an acceptable level of physical function and activity, post-surgery. This
      depends on both compliance with rehabilitation programmes and ability of the patient.
      Previously is has been found that there is only a small increase in patients' actual physical
      activity at post THR surgery, possibly due to the lifestyle changes adopted by the patients
      to manage their condition prior to undergoing surgical intervention.

      Physiotherapy is the mainstay of treatment for post-operative total hip replacements as it
      attempts to address the issues of impairment, disability and function. The use of
      physiotherapy as an intervention either before or after surgery has been investigated, with
      evidence to suggest that there are benefits to outcome. Post-operative physical training
      which includes physiotherapy is beneficial to patients with a THR, even if they have
      co-morbidities. It has been proposed that early and late post-operative protocols should
      include treadmill training, resistance training for the quadriceps muscles, arm interval
      exercise training with weight bearing exercises and eccentric training of the hip abductors.
      These protocols appeared to provide benefits for the participants, increasing strength,
      endurance and balance. However, they may not be applicable clinically in the current socio
      economic scenario. There is a need for effective and simple protocols which can be
      implemented across a range of patient groups in a cost effective manner.

      After undergoing the required rehabilitation programs post major surgery there appears to be
      a gap in the literature available as to the improvement and sustenance of physical activity
      levels. If physical activity is a key component of a healthy life style then its promotion
      and monitoring would enhance and inform the rehabilitation process. The promotion of physical
      activity has been successful in populations using pedometers as motivational tools. Whilst,
      these interventions have been implemented widely there is limited evidence specifically in
      populations following orthopaedic surgery. Perhaps this is because recovery to 'healthy'
      levels of activity has not been seen as an important objective of the rehabilitation process
      and simple functional recovery is all that has been targeted.

      'Participation' as defined within the World Health Organisation's International
      Classification of Functioning, Disability and Health classification tree is concerned with
      the free-living activity of individuals. The measurement of participation is difficult,
      except through a questionnaire based approach. To overcome the subjective nature of
      questionnaires, body worn monitors have been developed that allow the quantification of
      aspects of posture and stepping activity. Whilst the measurement of ability goes some way
      towards understanding the positive benefits of hip replacement as an intervention, knowledge
      of free-living activity would considerably extend the clinician/health professional
      understanding of the patient's recovery following the operation. Conventional tools for
      assessing participation include questionnaires such as the SF36, WOMAC, UCLA, Hip dysfunction
      and Osteoarthritis Outcome Score, Harris Hip Score and the Oxford Hip Score. Objective
      measurement of physical activity (e.g. using body worn monitors) removes the subjectivity of
      questionnaires. There is clearly a cost and time implication for the use of monitoring
      devices, so it is important that they provide additional, valuable information on free-living
      physical activity in comparison to quick to implement and readily accessible questionnaires.

      Modern pedometers are small, user friendly and relatively inexpensive (approximately £20),
      providing a suitable tool for wide spread use. Pedometers can be used both as a means of
      providing motivation for enhanced physical activity and as a monitoring device to quantify
      this activity. The use of such devices within interventions to enhance physical activity must
      be based on evidence of effectiveness. It has been established that the number of steps
      achieved in a day can be used to categorise physical activity levels. The 'step defined
      lifestyle index' categorises individuals taking less than 5000 steps/day as sedentary,
      5000-7499 steps/ day as low active lifestyle and more than 7500 steps/day as physically
      active. Those individuals meeting the 7500+ threshold appear to meet the moderate to vigorous
      physical activity recommendations for health. It is also suggested that achieving 7000- 8000
      steps per day Is associated with achieving 30 minutes per day of moderate to vigorous
      physical activity. To gain an understanding of the significance of the stepping guidelines,
      it has been established that 3000 accumulated purposeful steps per day equate to 30 minutes
      of moderate physical activity, which is the recommended daily physical activity quotient for
      good health. These recommendations can be used as targets, not only for healthy individuals
      but also for others including orthopedically challenged patients recovering from surgery.

      In a previous, observational study ( the research team have followed total hip replacement
      patients from before surgery to 3 months after surgery. Over this period the relationship
      between physical activity performance and aspects of ability and activity limitation was
      measured under laboratory/clinical conditions and free-living activity was recorded using a
      body worn activity monitor. This observational study revealed a number of facts about the
      recovery process post-surgery:

        1. At 3 month post-surgery, pain was generally absent and there was an improvement in hip
           strength and aerobic endurance. However, patients' hip strength and aerobic endurance,
           at 3 months after surgery, were observed to be far below the reference values of age and
           sex matched healthy individuals.

        2. Patients who were relatively active before undergoing total hip replacement, remained
           relatively active at the 3 month follow-up.

        3. The average number of steps taken by the patients before surgery was around 5200 steps
           per day and after surgery at the 3 month follow-up was approximately 5800 steps per day.

        4. However, 46 % of patients achieving less than 5000 steps per day at 3 months
           post-surgery.

        5. There was a direct relationship between the endurance of a patient and the physical
           activity levels achieved by the patient at 3 month follow up.

        6. It was also noted that the average time spent by the subjects in a sedentary position,
           i.e. sitting or lying, had minimally reduced per day from pre-surgery to the 3 month
           follow-up.

      Whilst some of the patients recovered to physical activity levels that are associated with
      good health, a large proportion did not. The need for a strategy to increase physical
      activity within this patient group is clear. Previous examples of successful pedometer based
      interventions motivate the current study which will aim to improve physical activity
      performance towards levels that are recognised to be health sustaining. The outcome measures
      used within the observational study will be repeated to allow direct comparison between study
      groups.

      The purpose of the proposed study is to investigate outcomes of a pedometer based
      intervention to improve physical activity levels and to examine if there could be a crossover
      effect of changes in stepping activity to hip strength and endurance following hip
      replacement surgery.

      The Chief investigator has undergone training in Good clinical practice and governance and
      has the experience of doing hospital based research.
    

Intervention name(s): Targetted protocol with pedometer; Accelerometer(ActivPAL)
Intervention type(s): Procedure; Device
Intervention description(s): 12 week protocol based on targetted steps are given to the patient along with a pedometer.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research