Trimodal Prehabilitation for Aneurysm Surgery Study
Condition: Aortic Aneurysm
MeSH terms: Aneurysm; Aortic Aneurysm
Study type: Interventional

Summary: 
      DESIGN: Single-centre, feasibility study AIMS: The aim of this study is to evaluate the
      acceptability and pre-operative impact on functional capacity of a trimodal prehabilitation
      program in a cohort of patients undergoing aneurysm repair.

      This will enable the design (feasibility and power) of a large scale Randomised Controlled
      Trial.

      Expected outcomes

        -  The potential number of patients who would benefit, the compliance and acceptability of
           a pre-operative prehabilitation programme will be calculated.

        -  Preoperatively, expected at 6-weeks, the change in physical fitness of patients
           (assessed by the physical function section of SF-36 and measured with peak flow/6-minute
           walk testing) during the pre-operative phase will be assessed in both groups.

        -  The effects on quality of life, anxiety and depression on each study participant will be
           assessed immediately pre-op, expected at 6-weeks.

        -  The number of patients who are able to reduce or cease smoking will be reported during
           the pre-op phase (expected at 6 weeks), as will length of hospital stay after aortic
           surgery, expected at 6-8 weeks.

      POPULATION: Patients undergoing planned elective aortic surgery procedures

      ELIGIBILITY: Adult patients (over 18 years) undergoing elective open and endovascular
      aneurysm repair with capacity to consent and physical fitness to undergo an pre-operative
      exercise programme DURATION: 1 year from 1st June 2014
    

Detailed description: 
      Proposed intervention - The introduction of a biopsychosocial intervention before surgery.
      The physical exercise programme will be a prescribed exercise training twice per week which
      will be supported by a physical therapist and vascular nurse specialist. A trained clinical
      psychologist will also deliver a brief psychological intervention based on cognitive
      behavioural therapy (CBT) techniques in two sessions to modify illness, surgical preparation
      and rehabilitation beliefs. Lastly patients will be counselled and referred to smoking
      cessation services as appropriate by the vascular nurse specialist.

      Baseline information will include patient demographics and medical history, quality of life
      assessment using SF-36 forms, hospital anxiety and depression scale (HADS) and exercise
      testing by a standardised 6-minute walk test Information immediately pre-operatively will be
      collected to include a repeat assessment of physical function with a 6-minute walk test,
      SF-36 assessment and HADS scores. Smoking cessation rate will be collected.

      A pre and post-intervention group will be studied over a 1-year period. We will report on the
      eligibility, acceptability and pre-operative effect of this trimodal rehabilitation
      programme.

      AIM AND EXPECTED IMPACT

      This is a non-randomised pre-post intervention pilot study to understand the acceptability
      and pre-operative effects of a combined physical, psychological and social prehabilitation
      package in patients undergoing aneurysm repair. This will enable the design (feasibility and
      power) of a large scale Randomised Controlled Trial.

      Our hypotheses include:

        -  The introduction of a prehabilitation programme will be acceptable to the majority of
           patients undergoing aneurysm surgery

        -  A physical pre-operative exercise programme will increase physical fitness before
           surgery

        -  A psychological intervention based on cognitive behaviour therapy techniques will reduce
           anxiety before surgery and prepare patients better for their post-operative recovery

        -  The introduction of psycho-social counselling for smoking cessation will encourage more
           patients to give up smoking pre-operatively

      PARTICIPANT ENTRY: PATIENTS

      PRE-REGISTRATION EVALUATIONS The research team will identify eligible patients for
      recruitment into the study via clinic lists, multidisciplinary meetings and referral letters
      before the patient attends their clinic appointment. Only adult patients undergoing aortic
      surgery will be selected. Patient information leaflets will be given to selected patients and
      patients will be given the opportunity to read them and ask questions before deciding whether
      or not to participate.

      INCLUSION CRITERIA

        -  Adult patients (>18 years old) undergoing aortic aneurysm repair.

        -  Ability to comprehend and retain instructions regarding self-training

        -  Physical fitness allowing participation in an exercise programme.

      EXCLUSION CRITERIA

        -  Minors (<18 years old)

        -  Adult patients who do not have capacity to consent.

        -  Emergency or urgent procedures who will not have a necessary 6 week lead in time until
           operation.

      WITHDRAWRAL CRITERIA The patient will be made aware that they may withdraw from the study at
      any time without providing a reason; their care and treatment will not be affected

      STUDY DESIGN The acceptability of this programme will be studied and the pre-operative impact
      on functional capacity will be assessed in a comparator (pre-intervention) and
      post-intervention group.

      Patients

      Patients from Imperial College Healthcare NHS Trust Vascular Unit undergoing aortic aneurysm
      repair will be recruited.

      Study Protocol

      Our current vascular pre-operative assessment service is an established nurse led service,
      run by a dedicated aortic clinical nurse specialist. The prehabilitation would run in
      conjunction with the current pre-operative screening measures currently in place - which
      include dobutamine stress echocardiography, renal assessment and pulmonary function tests.

      -Phase 1 - Comparator (pre-intervention) evaluation

      Patients undergoing present standard of care - i.e. standard work-up for aneurysm repair
      without nurse-led prehabilitation strategy, who meet inclusion and exclusion criteria will be
      given a patient information leaflet, informed they are in the pre-intervention group and
      consented for inclusion in the study as detailed above.

      At the baseline appointment, on the same day as work-up tests, information will be collected
      on standardised data collection sheets to include:

        -  Patient demographics and medical history

        -  Baseline Quality of Life assessment using SF-36 forms

        -  Hospital anxiety and depression scale (HADS).

        -  Exercise testing by a standardised 6-minute walk test

        -  Peak Expiratory Flow Rate (PEFR)

      Information immediately pre-operatively will be collected the day before operation (our
      standard admission is the day before) to include a repeat assessment of physical function
      with a 6-minute walk test, Peak Expiratory Flow Rate (PEFR), SF-36 assessment and HADS
      scores. Smoking cessation rate over the pre-operative period will be collected. The aneurysm
      repair will proceed as standard of care, and will be unchanged from standard practice.

      -Phase 2 - Intervention

      Proposed intervention - The introduction of a biopsychosocial intervention before surgery.
      The physical exercise programme will be prescribed exercise training twice per week which
      will be supported by our vascular nurse specialist, previously shown to have a small effect
      on length of stay in cardiac patients [12].

      A trained specialist (a registered psychologist) will also deliver a brief psychological
      intervention based on cognitive behavioral therapy (CBT) techniques in two sessions to modify
      illness, surgical preparation and rehabilitation beliefs. This psychological intervention has
      been shown to be effective in encouraging claudicants to initiate and continue exercise
      training [13].

      Lastly patients will be counselled and referred to smoking cessation services as appropriate.

      Phase 2 protocol - During an initial set-up phase comprehensive information booklets will be
      developed to instruct the patient on these three modes of prehabilitation.

      Patients who are eligible for the study will be approached in the same way as patients
      studied in the comparator group. At the baseline study visit, the same baseline information
      will be collected as for the comparator group i.e.:

      At the baseline appointment, on the same day as work-up tests, information will be collected
      on standardised data collection sheets to include:

        -  Patient demographics and medical history

        -  Baseline Quality of Life assessment using SF-36 forms

        -  Hospital anxiety and depression scale (HADS).

        -  Exercise testing by a standardised 6-minute walk test

        -  Peak Expiratory Flow Rate (PEFR)

      In addition patients will receive:

        -  Information booklets

        -  Physical exercise plan, run-through and explanations.

        -  Psychological therapy on this day or a mutually convenient day for patient and
           therapist.

        -  Counselling by the nurse specialist and referral for smoking cessation

      Patients will receive a telephone follow-up with the nurse specialist at week 2 and week 4 to
      evaluate progress and to encourage compliance with the programme. Between weeks 5-6 the
      patient will have a further session with the clinical psychologist, just prior to admission
      for treatment, to prepare them for their impending hospitalisation.

      Again, information immediately pre-operatively will be collected to include a repeat
      assessment of physical function with a 6-minute walk test, Peak Expiratory Flow Rate (PEFR),
      SF-36 assessment and HADS score. In addition, patients will be asked to fill out a
      questionnaire assessing compliance with and acceptability of the prehabilitation programme.
      Smoking cessation rate will be collected.

      Data Collection

      The following demographic data will be recorded on standardised data collection forms for
      each patient, collected from patient records and the patient interviews:

        -  Inclusion and exclusion criteria

        -  Medical history/risk factors

        -  ASA classification

        -  Planned operative procedure details

        -  Physical status using functional capacity, measured in metabolic equivalents (METs),
           with a Duke Activity Status Index (score of less than 4 indicates poor physical
           function).

      Functional capacity may be usually expressed in metabolic equivalents (METs), where one MET
      is defined as the oxygen consumption of a 70-kg man at rest. Greater than 7 METs of activity
      tolerance is considered excellent, whereas less than 4 METs is considered poor activity
      tolerance.

      The Duke Activity Status Index suggests questions that correlate with MET levels; for
      example, walking on level ground at about 4 miles per hour or carrying a bag of groceries up
      a flight of stairs expends approximately 4 METs of activity. This system is used by the
      Cleveland clinic for pre-operative cardiac evaluation. It allows a pre-operative assessment
      of physical function to assess predicted ability to cope at home after surgery. A brief,
      self-completed questionnaire (Appendix 1) can provide a standardized assessment of functional
      status that correlates well with an objective measure of maximal exercise capacity [14].

      Post-operative data will be collected for patients in order to plan for a further study based
      on reducing length of stay.

        -  Inpatient complications: grade and details using standardised data collection sheets

        -  Length of stay

        -  HDU/ITU use

        -  Mortality

      At base line visit and prior to operation each patient will be assessed using:

        -  Baseline Quality of Life assessment using SF-36 forms

        -  Hospital anxiety and depression scale (HADS).

        -  Exercise testing by a standardised 6-minute walk test

        -  Peak Expiratory Flow Rate (PEFR)

      An event log will be recorded for each patient throughout the study period.

      Patients undergoing intervention will be asked to complete a short questionnaire on
      compliance and acceptability of the prehabilitation programme.

      ANALYSIS Completed data collection sheets will be analysed for omissions and missing data
      completed before being logged onto a central database and analysed by the research team at
      Imperial College, London, St. Mary's Campus.

      The two groups will be compared using simple statistical methods. We intend to analyse and
      report on the following

        -  The number of patients who accepted inclusion into a pre-operative prehabilitation
           programme will be calculated.

        -  The change in physical fitness of patients (assessed by the physical function section of
           SF-36 and measured with peak flow/6-minute walk testing) during the pre-operative phase
           will be assessed pre and post-intervention groups.

        -  The effects on quality of life.

        -  The effect of a programme on anxiety and depression on each study participant will be
           assessed.

        -  The number of patients who are able to reduce or cease smoking will be reported.

        -  Compliance and acceptability of the prehabilitation programme.

        -  Morbidity and Mortality, HDU/ITU resource use as well as Length of hospital stay after
           aortic surgery.
    

Intervention name(s): Post-intervention arm = Prehabilitation
Intervention type(s): Behavioral
Intervention description(s): Introduction of a physical exercise training programme, psychological counselling and smoking cessation advice
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care