Functional Prehabilitation and Major Elective Surgery

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.

Inclusion Criteria:

- Patients 50 years and older undergoing major abdominal and non-cardiac thoracic
operations with an anticipated postoperative ICU stay will be eligible for initial
screening. A timed up-and-go assessment will be performed on all who individuals
interested in participating. Individuals with a timed up-and-go score of greater than
10 seconds are eligible to participate.

- Women and men will both be recruited for the study. Minorities and non-minorities
will be recruited for the study.

Exclusion Criteria:

- Participants under 50 years

- Patients not going to the ICU post-operatively

- Patients having a different kind of operation than major abdominal/non-cardiac
thoracic

- Those who complete the timed up-and-go in 10 seconds or less or

- patients who cannot complete the timed up-and-go

- Patients who cannot undergo informed consent

- Patients with vision impairments who cannot visualize the pictures involved with the
CAM-ICU

- Patients who do not speak English will be excluded so that confusion created by a
language barrier is not confused with post-operative delirium.

- Pregnant women, prisoners, and decisionally challenged subjects.