Functional Prehabilitation and Major Elective Surgery
Condition: Surgical Complication; Physical Therapy; Timed Up and Go
Study type: Interventional

Summary: 
      Purpose: To compare post-operative functional outcomes in patients undergoing preoperative
      functional prehabilitation versus standard of care preoperative management in older adults
      undergoing major elective operations.

      Hypothesis: Older adults undergoing preoperative functional prehabilitation (nine sessions of
      home physical therapy over three weeks) will have improved physical function and reduced
      delirium in comparison to usual preoperative care following major abdominal and thoracic
      operations.

      Specific Aims:

      (#1) To compare the difference in the timed up-and-go, Mini Mental Status Exam (MMSE), the de
      Morton Mobility Index, Modified Physical Performance Test (MPPT), and short physical
      performance battery scores in the control and intervention groups at the preoperative and
      initial assessment timepoints.

      (#2) To compare the difference in the timed up-and-go, Mini Mental Status Exam (MMSE), the de
      Morton Mobility Index, Modified Physical Performance Test (MPPT), and short physical
      performance battery scores in the control and intervention groups at the 60-days
      postoperative and the initial assessment timepoints.

      (#3)To compare the rates of ICU delirium and need for post-discharge institutionalization in
      patients in the control and interventions groups.

      (#4) To compare post-operative complications
    

Detailed description: 
      BACKGROUND Prehabilitation has been studied in relation outcomes after surgery. One common
      area studied is how it affects post-operative outcome for knee replacement patients.
      Prehabilitation was found to increase strength and function in older adults. {Swank, 2011.
      #1} Prehabilitation increased leg strength and the ability to perform functional tasks in
      these patients.

      Prehabilitation has also been studied in patients undergoing coronary artery bypass graft
      surgery (CABG). Primary outcome measures were: anxiety and length of hospital stay; secondary
      outcome measures were: depression, physical functioning, cardiac misconceptions and cost
      utility. Prehabilitation was found to decrease depression and improve physical functioning.
      {Furze, 2009. #2}

      Prehabilitation was also found in one study to reduce postoperative complications, length of
      stay, and declines in functional disability compared to the control group, while improving
      quality of life, in patients having cardiac and abdominal surgery. {Carli, 2005. #3}

      No research has been done linking prehabilitation to the incidence of delirium. The research
      team has extensive experience studying delirium. Decreased cognition and functional ability
      has been linked to delirium and poorer outcomes post-operatively. {Robinson, 2009. #4}.
      Theoretically, by improving functional ability pre-operatively, post-operative outcomes will
      improve and delirium will decrease. This study will examine if this is true.

      The current standard of care for abdominal and non-cardiac thoracic operations does not
      involve prehabilitation. (Cardiac operations were excluded due to the increased risk for
      heart-related complications during prehabilitation, such as Myocardial Infarction (MI).) The
      control group will receive standard of care pre-operative care, with the exception of
      baseline functional assessments.

      OUTCOME MEASURES:

      Primary Outcome Variable: A timed up-and-go, Mini Mental Status Exam, the de Morton Mobility
      Index, Modified Physical Performance Test (MPPT), and a short physical performance battery
      will be performed 60 days following the operation. The difference in the timed up-and-go and
      the short physical performance battery between 60 days postoperatively and at the initial
      assessment will be compared in the control and intervention groups.

      Secondary Outcomes: The secondary outcome variables will be the rate of need for discharge to
      an institutional care facility and ICU delirium. These two variables will be compared in the
      control and intervention groups.

      Other Outcomes: Evaluate post-operative complications. These two variables will be compared
      in the control and intervention groups.

      STUDY DESIGN AND RESEARCH METHODS Baseline Assessment: On study entry, each participant will
      have a timed up-and-go, Mini Mental Status Exam, de Morton, Modified Physical Performance
      Test (MPPT), and a short physical performance battery performed. Routine demographics will be
      performed. Traditional and geriatric preoperative variables will be recorded.

      Study Groups: Participants will be randomized to receive standard of care (control) or the
      intervention of prehabilitation.

        1. Control Group: The control group will undergo routine pre-operative management.

        2. Intervention Group: The intervention will consist of nine 45 minute long physical
           therapy sessions. Sessions will occur three times weekly at the patient's home.

      Assessment of Intervention Effectiveness: Immediately prior to the operation, all
      participants will undergo repeat timed up-and-go, Mini Mental Status Exam, the de Morton
      Mobility Index, Modified Physical Performance Test (MPPT), and short physical performance
      battery. The difference in scores between the preoperative assessment and the initial
      assessment at enrollment will be compared in the control and intervention groups.

      Operations: The scheduled operation will be performed.

      Postoperative Adverse Outcomes: Postoperative adverse outcomes will be recorded using
      standardized definitions.

      DATA ANALYSIS PLAN A sample size of 100 people, because we anticipate many will complete the
      Up and Go in 10 seconds and faster and will be screen fails. A total of 40 subjects will be
      randomized, 20 per group. The outcomes of timed up and go, Short Physical Battery, Modified
      Physical Performance Test (MPPT), and de Morton will be compared from baseline to immediately
      pre-operatively and immediately post-operatively.

      The data will be compared as continuous variables using a non-parametric T-test. Baseline
      demographic clinical data will be compared in the study and control groups using
      non-parametric chi square or T-test where appropriate.
    

Intervention name(s): Functional Assessment; Prehabilitation
Intervention type(s): Procedure; Procedure
Intervention description(s): Both arms of the study will undergo functional assessments at three points during the study progress.
BASELINE ASSESSMENT: On study entry, each participant will have a timed up-and-go, Mini Mental Status Exam, de Morton, Modified Physical Performance Test (MPPT), and a short physical performance battery performed.
ASSESSMENT OF INTERVENTION EFFECTIVENESS:
Immediately prior to the operation, all participants will undergo repeat testing. The difference in scores between the preoperative assessment and the initial assessment at enrollment will be compared in the control and intervention groups.
POST-OPERATIVE ASSESSMENT: Repeat testing will be performed 60 days following the operation.; The intervention will consist of nine 45 minute long physical therapy sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: delirium; surgery; operation; geriatric; complication