Overview

This trial is active, not recruiting.

Condition aortic aneurysm
Treatment prehabilitation
Sponsor Imperial College London
Start date November 2014
End date July 2015
Trial size 30 participants
Trial identifier NCT02292927, 14/LO/1368

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients treated as standard before intervention
Patients after the institution of a physical, psychological and social training programme
prehabilitation
Introduction of a physical exercise training programme, psychological counselling and smoking cessation advice

Primary Outcomes

Measure
The number of patients who accepted inclusion into a pre-operative prehabilitation programme
time frame: Collected at screening
Change in fitness (assessed by the physical function section of SF-36 and measured with peak flow/6-minute walk testing)
time frame: Collected at baseline and (expected) 6 weeks
The effects on quality of life (SF-36 scores)
time frame: Collected at baseline and (expected) 6 weeks
Axiety and Depression scores (Hospital Anxiety and Depression Scale)
time frame: Collected at baseline and (expected) 6 weeks
Smoking cessation rate (%)
time frame: Collected at baseline and (expected) 6 weeks
Compliance of the rehabilitation programme (assessed by bespoke questionnaire)
time frame: Collected at baseline and (expected) 6 weeks
Acceptability of the prehabilitation programme.(assessed by bespoke questionnaire)
time frame: Collected at baseline and (expected) 6 weeks

Secondary Outcomes

Measure
Morbidity (number of grade 3 or higher complications assessed by the Clavien - Dindo scale)
time frame: Collected at (expected) 6 weeks +hospital stay
Mortality (%)
time frame: Collected at (expected) 6 weeks +hospital stay
HDU/ITU resource use (number of days stay)
time frame: Collected at (expected) 6 weeks +hospital stay
Length of hospital stay after aortic surgery (number of days)
time frame: Collected at (expected) 6 weeks +hospital stay

Eligibility Criteria

Male or female participants from 40 years up to 95 years old.

Inclusion Criteria: - patients undergoing elective repair, willing/able to undertake a period of prehabilitation, and those able to comprehend and retain instructions regarding self-training. Exclusion Criteria: - Symptomatic patients or those undergoing urgent treatment (< 2 weeks)

Additional Information

Official title Maximising Recovery to Health Through Trimodal (Bio Psycho Social) Prehabilitation for Aneurysm Surgery Study
Description 1. INTRODUCTION 1.1 BACKGROUND Prehabilitation is used in sports and the military to avoid injury and there is evidence from the surgical literature that physical prehabilitation can improve the patient fitness before major procedures. It is already used with great effect within orthopaedics; joint replacement patients who participate in strength-based training with aerobic and flexibility exercises for just six weeks pre-operatively reduce their odds of requiring inpatient rehabilitation by 73% [1]. In other surgical specialties, prehabilitation has also been shown to improve pre-operative physical function [2,3]. In a pre-post intervention study, although the postoperative complication rates and the hospital length of stay were similar, there were significant improvements in post-operative walking capacity. At 8 weeks, 81 % of the prehabilitated patients were recovered compared with 40 % of the pre-intervention group [4]. In contrast, a randomised controlled trial [5] has shown no difference between control and intervention groups where prehabilitation was introduced. The authors claim that this may be due to the fact that walking and deep breathing exercises (given to the control group) were effective alone, but may also be that differences were small in this cohort; these patients were fit when compared to a population of patients with aneurysm disease. The literature surrounding the prehabilitation concept is largely biased towards the use of exercise alone. Rather than a purely physical assessment and pre-operative training, thought should be afforded to the wider impact of major surgery on patients undergoing major surgery. For example, there is strong evidence suggesting that undergoing major surgery has significant implications for patients' post-operative psychological wellbeing. Qualitative data suggests that some patients experience a significant loss of confidence and feelings of anxiety in the aftermath of major cardiac surgery due to feeling unable to do tasks and activities they had previously undertaken [6]. Psychological distress could further delay patients' recovery as increased levels of stress have been linked with delayed recovery from surgery [7]. Psycho-educational support for surgical patients has significant benefits on psychological and clinical outcomes [8-10]. Interventions are varied and include elements such as supplying information, cognitive coping strategies, relaxation, reassurance and support, and rehearsal, which prepare patients to tackle the rigorous efforts needed to recover from major surgery. Lastly, there are a number of psycho-social interventions targeting specific health behaviours that would obviously benefit the recovery of patients. The most commonly known and widely studied health behaviour intervention of significant benefit is that of smoking cessation. Giving up smoking 6 weeks before surgery decreases the post-operative complication rates by over 50%. Whilst the effects of giving up smoking are well known, efforts to curtail the need for nicotine are often ignored, perhaps from lack of knowledge within the medical disciplines [11]. 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. 2. 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 3. PARTICIPANT ENTRY: PATIENTS 3.1 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. 3.2 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. 3.3 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. 3.4 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. 4. 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. The unit performs in the region of 100 abdominal aortic repairs annually with a further 100 thoracic aneurysms. Inclusion criteria will be those patients undergoing elective repair, willing/able to undertake a period of prehabilitation, and those able to comprehend and retain instructions regarding self-training. Symptomatic patients or those undergoing urgent treatment (< 2 weeks) will be excluded as will those declining to participate. Deliberately broad inclusion and exclusion criteria have been chosen to fully understand the proportion of patients that may benefit from this intervention. Allowing for a 25% ineligibility to be included and 25% refusing to enter into the study this would allow 50 patients to be recruited providing vital information on the acceptability and potential of this intervention. All patients undergoing aneurysm repair of any type and the reasons for inclusion and exclusion in the study will be recorded to enable a comprehensive evaluation of the number of patients potentially suitable for a prehabilitation programme. We plan to identify potential patients from the vascular outpatient clinics at initial point of referral to the work-up nurse led service. A standardised screening assessment sheet will be used. At this point they will be given a patient information leaflet regarding the study (for both pre and post intervention groups). On the day of their standard pre-assessment those who have been given a patient information leaflet, who agree to be in the study, will be consented. Patients will only be consented after a chance to ask unanswered questions. If the patient agrees to participate, he or she will be asked to sign a consent form, which will be kept securely in a locked office. Those agreeing to participate in the study will receive an additional appointment on the same day with the vascular nurse specialist for baseline measurement and targeted instruction on the Bio Psycho Social Prehabilitation Programme. It is anticipated that this would not take more than two hours in addition to their standard appointments. 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. 5. 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. 6. 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. Appendix 1. THE DUKE ACTIVITY STATUS INDEX Circle Yes or No to the questions Activity Yes or No Weight 1. Are you able to take care of yourself: that is, eating, dressing, bathing, or using the toilet? Y N 2.75 2. Are you able to walk indoors, such as around the house? Y N 1.75 3. Are you able to walk a block or 2 on level ground? Y N 2.75 4. Are you able to climb a flight of stairs or walk up a hill without stopping? Y N 5.50 5. Are you able to run a short distance? Y N 8.00 6. Are you able to do light work around the house like dusting or washing dishes? Y N 2.70 7. Are you able to do moderate work around the house like vacuuming, sweeping floors, or carrying in the groceries ? Y N 3.50 8. Are you able to do heavy work around the house like scrubbing floors, or lifting or moving heavy furniture? Y N 8.00 9. Are you able to do yard work like raking leaves, weeding or pushing a power mower? Y N 4.50 10. Are you having sexual relations? Y N 5.25 11. Are you able to participate in moderate recreational activities like golf, bowling, dancing, doubles tennis, or throwing a baseball or football? Y N 6.00 12. Are you able to participate in strenuous sports like swimming, singles tennis, football, basketball or skiing? Y N 7.50 Total the weight for each YES answer given, this will give you the DASI Score Scoring the Duke Activity Status Index: Functional Capacity in METS = (DASI score) x 0.43 + 9.6 then divide by 3.5
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Imperial College London.