The Assessment of the Feasibility of a Home Based Exercise Programme in the Older Patient Following Major Surgery
The Assessment of the Feasibility of a Home Based Exercise Programme in the Older Patient Following Major Surgery
The primary aim of this study is to establish if it is possible for patients who have
 undergone major body surgery to complete a home based exercise training program and complete
 the assessments required to measure physical and cognitive function. If the investigators can
 establish that it is feasible to complete the training and test's then further research can
 follow using these methods to determine whether it is possible to improve the physical
 function of older patients undergoing major abdominal surgery in the period following surgery
 by using a simple exercise regimen that can be carried out at home. By targeting physical
 function in this way the investigators hope to determine if it is a method for improving
 frailty and well being. In turn it may also have a positive impact on health service
 provision.
Frailty is a geriatric syndrome describing a lack of physiological reserve. It is an
 independent risk factor for morbidity, mortality and increased length of hospital stay. Five
 criteria can be used to describe Frailty: weight loss, exhaustion, diminished hand-grip
 strength, slow walking speed, and low physical activity. Sarcopenia, the loss of skeletal
 muscle mass and strength, is a key component of all of these criteria and of Frailty itself.

 By assessing Frailty, vulnerable patients can be recognised early so that additional measures
 can be implemented. Interventions to ameliorate the severity of an individual's Frailty are
 currently the focus of much attention as these can positively impact on the patients physical
 and cognitive function and well-being. In turn this has a positive impact on health service
 provision reducing hospital length of stay, morbidity and mortality.

 The exercise programme used in this study incorporates the High-Intensity Functional Exercise
 (HIFE) programme for older individuals developed by Umea University Sweden with exercises
 incorporated from the Help the Aged Preventing Falls Programme. The exercises are designed
 such that they can be performed at home with no additional aids. The participants will be
 required to begin the programme on discharge from hospital and undertake exercises three
 times per week. They will receive instruction, help and support prior to discharge and
 throughout the 6 month exercise period. The participants will be required to complete an
 exercise diary to monitor their compliance with the programme and to determine the
 feasibility of a home based exercise programme as an intervention measure.

 The outcome measures of physical function will be assessed by the Handgrip strength and Step
 Box testing plus questionnaires assessing daily activities, Sarcopenia will be assessed using
 the Handgrip test to measure muscle strength and quantification of muscle mass through muscle
 ultrasound (USS) imaging. Cognitive function will be assessed by the use of validated
 questionnaire and online cognitive tests. Frailty by the Reported Edmonton Frail Scale.

 Experimental design and methods:

 Potential participants will be identified from local multidisciplinary team (MDT) meetings.
 These are held weekly and all patients undergoing major cavity intra-abdominal surgery are
 discussed at the relevant MDT for their surgical speciality. Those patients who meet the
 eligibility criteria will be noted by the usual care team and they will make the initial
 approach to the patient regarding the study.

 30 participants will be recruited to the study and allocated randomly to either the exercise
 intervention arm or the control arm of the study. Participants will be involved in the study
 for approximately 8 months depending upon when they are recruited to the study
 pre-operatively. The post-operative exercise programme runs for 6 months.

 All aspects of the screening process are part of the standard NHS pre-operative assessment
 and include National Health Service (NHS) blood tests, ECG, clinical examination and medical
 questionnaire.

 Participants will be asked to attend five testing sessions, one pre-operatively and four
 postoperatively. These sessions will wherever possible be timed with planned clinic
 appointments scheduled as part of the standard NHS care provided by their surgical
 speciality. The first session shall occur at the time of the pre-operative assessment and
 will require the participant to complete all of the assessments (detailed below). The second
 session occurs three days postoperatively whilst the participant is an inpatient, of the
 physical assessments only the handgrip strength test shall be completed. The remaining three
 sessions occur at 6 weeks, 3 months and 6 months post-operatively and all of the assessments
 shall be completed. At each session blood tests for monitoring of Haemoglobin levels and
 inflammatory markers shall be collected, some of which will be a part of the standard NHS
 care.

 Assessment of physical function and Sarcopenia:

 Handgrip test: Three readings (maximal isometric contraction of the hand using the Takei hand
 dynamometer) for each hand will be recorded with the average of the three readings
 calculated.

 Step Box test: Participants will complete three sets of step box steps. The first set
 involves 10 steps at a slow pace, the second set, 20 steps at normal walking pace and the
 final set, 20 steps as fast as they can. The height of the step is dependent upon the height
 of the participant. The time to complete each set and the heart rate during stepping and in
 the recovery period is recorded.

 The recovery period is 5 minutes or the time taken for the heart rate to return within 5 bpm
 of the resting heart rate.

 Ultrasound of vastus lateralis: Ultrasound images will be taken of the vastus lateralis at a
 point 2/3 along the axis from the greater trochanter of the femur and the knee joint-line. At
 this point a sagittal image will be captured to delineate the anterior and posterior borders
 of the muscle. Muscle depth, bulk and muscle pennation angle will be calculated.

 Assessment of Frailty:

 Reported Edmonton Frail Scale: This is a validated frailty scoring system.

 Assessment of Cognition:

 The Montreal Cognitive Assessment (MoCA) questionnaire is a validated cognitive screening
 tool to screen for mild to moderate cognitive impairment.

 Computerised Cognitive test battery: This involves two computerised tests, the Simon test and
 the Symbol Substitution test.

 Questionnaires:

 The following validated questionnaires will be used; The Duke Activity Status Index (DASI)
 assess activities of daily living, the EQ5D evaluates health status, the International
 Physical Activity - Short Form (IPAC-SF) questionnaire assess physical activity. Depression
 shall also be screened for by using the Geriatric Depression Scale (GDS).

 Assessment of Feasibility:

 The feasibility of the intervention will be determined through interviews, exercise diary's
 and feedback questionnaires.

 Removal of participants from the study:

 Patients will be withdrawn from the study if they wish to withdraw consent or loose the
 capacity to consent. Further if they develop post-operative complications of the
 cardio-vascular system, cerebrovascular system or complications of the operative wound site.
 Also if they discontinue with the exercise programme either temporarily or permanently.

 Sample size calculation:

 This is a feasibility study, there is no current data from which to estimate the sample size.
-  Inclusion Criteria:

 -  Patients undergoing major body cavity surgery.

 -  Male and Female patients.

 -  Age greater than 70 years.

 -  Patients undergoing neo-adjuvant chemotherapy will be included.

 -  Exclusion Criteria:

 -  Participation in a formal exercise regime

 -  A BMI > 35 kg·m2

 -  Active cardiovascular disease: uncontrolled hypertension (BP > 180/100), angina,
 heart failure (class III/IV), arrhythmia, right to left cardiac shunt, recent
 cardiac event

 -  Taking beta-adrenergic blocking agents.

 -  Cerebrovascular disease: untreated aneurysm (large vessel or intracranial).

 -  Respiratory disease including: pulmonary hypertension.

 -  Metabolic disease: hyper and hypo parathyroidism, untreated hyper and
 hypothyroidism, Cushing's disease.

 -  Musculoskeletal or neurological disorders

 -  Family history of early (<55y) death from cardiovascular disease

 -  Severe rheumatoid arthritis limiting ability to perform any part of the
 assessment process.

 -  Unable to complete the consent process.