Mentored Prehabilitation for Patients Having Aortic Aneurysm Surgery: a Pilot Randomised Control Trial
POWER: PrehabilitatiOn Workshop and Mentored Exercise Programme in Patients Having Elective Aortic Aneurysm Repair
Sponsors
Source
Guy's and St Thomas' NHS Foundation Trust
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
Brief Summary
Protocol Short Title:
POWER Study — PrehabilitatiOn Workshop and mentored Exercise programme in patients having
elective aortic aneurysm Repair
Population:
Patients scheduled for elective repair of aortic aneurysm at St. Thomas' Hospital
Screening and recruitment:
Eligible participants will be identified by the vascular team; during the weekly
multi-disciplinary team meeting, or via the clinical nurse specialist from tertiary
referrals.
Participant information leaflets will then be sent out to eligible patients 2 weeks before
the outpatient appointment.
Recruitment will be carried out during surgical outpatient appointments. Written informed
consent will be obtained and participants will be randomised into three groups.
This pilot study will help us to:
1. To assess feasibility of screening, recruitment and retention
2. To assess adherence to intervention and blinding.
3. To generate outcome data that may be used to power definitive clinical trials
Primary objective To determine the feasibility of delivery of a randomised control trial.
Secondary objective (s) To determine baseline outcome data that may be used to power a
randomised control trial.
Number of Subjects/Patients A convenience sample of 15 patients per group is planned, with a
total of 45 patients recruited. At GSTT 200-250 aortic aneurysm operations are performed
annually. We aim to recruit 40% of those eligible and screened. This would equate to 4-6
recruited per month.
Trial Design Single-blinded, randomised, controlled pilot study.
Patients will be allocated into the following groups:
Control group:
- Current standard practice, no prehabilitation workshop.
Non-mentored group:
- Prehabilitation workshop with no further patient contact.
- Participants to be given a prehab 'pack' which includes advice and a diary card.
Mentored group:
- Prehabilitation workshop with addition of regular 'mentoring' for up to 8 weeks after
the workshop.
- Participants to be given a prehab 'pack' which includes advice and a diary card.
Primary Endpoints:
1. Screening and recruitment
2. Retention, blinding and follow up procedures.
3. Adherence
Secondary Endpoints:
To determine baseline outcome data that may be used to power a randomised control trial by
examining the following:
1. Composite of post-operative cardiac, respiratory and renal complications at 30 days
2. Mortality at 30 days following surgery.
3. Length of postoperative hospital stay
4. Quality of life (EQ-5DL)- post surgery.
5. Tests of activity and function
Main Inclusion Criteria
Inclusion:
Elective all aortic aneurysm repair Willingness to return after 8 weeks for re-assessment of
secondary measures Participants must have an e mail address.
Exclusions:
Urgent or emergency repair Contraindications to exercise (doesn't apply for short term
illness) Severe musculoskeletal disorders preventing exercise
Detailed Description
Introduction
Optimising fitness prior to surgery, known as prehabilitation, has the potential to reduce
risk and improve post-operative outcomes by increasing functional capacity and physiological
reserve. Prehabilitation strategies include educating patients with lifestyle modifications
such as smoking cessation, nutrition, exercise and anxiety reduction. Deconditioning and
sarcopenia has been shown to predict a higher cost amongst patients undergoing major
abdominal surgery [1] and has been recently identified as an independent predictor of
hospital length of stay [2], hence optimising functionality may prevent morbidity.
There is a growing need to improve outcomes in vascular surgery, yet few examples of vascular
prehabilitation exist. The 2018 Get It Right First Time (GIRFT) report [3] states one of the
key recommendations is to improve the use of prehabilitation and to make it more consistent
via NHS England commissioning.
Multiple studies with varying prehabilitation strategies have been published in the last
decade [4]. Prehabilitation has been associated with encouraging results in major colorectal
and upper gastrointestinal cancer surgery [5],[6]. Data such as these have also led to the
development of prehabilitation services within NHS Trusts [7].
Supervised training programmes have shown to improve patient's anaerobic threshold and
fitness in patients having aortic aneurysm repairs [8],[9],[10]. A recent randomised
controlled trial has provided evidence to support supervised exercise training, by suggesting
improvements in postoperative outcome, length of stay, postoperative pain and
complications[11]. Historically there were concerns about exercising in this cohort of
patients, however recent studies has shown that aneurysm expansion does not occur with
exercise and exercise is safe [11],[12].
St. Thomas' Hospital is a tertiary referral centre performing between 200-250 aortic aneurysm
repair operations annually. We serve a large demographic from South East England and receive
referrals from across the whole of the UK, making the provision and appeal of a supervised
prehabilitation exercise programme difficult.
Prehabilitation education provided is especially effective if delivered at the right time,
for example, the need for high risk surgery; the so called 'teachable moment' [13]. Despite
the recent surge in evidence surrounding the benefits of prehabilitation, it is not yet part
of established pathways. There has been some guidance as to how to practically achieve
prehabilitation into our clinical practice but there is still work to be done in terms of
integrating it into perioperative pathways [14].
A mentored prehabilitation programme that does not require supervised exercise is
generalisable and feasible, but yet to show improvements in patient outcomes.
Over the last 12 months we have been delivering a group based prehabilitation and exercise
workshop named 'Road to Recovery'. This is a physiotherapist and anaesthetist led
prehabilitation workshop, targeted to provide valuable education and advice to patients and
their families about their surgery, hospital stay and expectations for discharge, diet,
lifestyle and exercise before their aneurysm surgery. The advice emphasises the importance of
empowering patients to take control of their own health. The workshop is designed to educate
patients and allay their fears and anxieties around hospital admission and surgery.
The physiotherapist then provides a detailed lecture on exercise and the relevance of
strength in the recovery period. An interactive, group-based demonstration of various safe
and approved practical exercises is then undertaken. Feedback from the patients has been
positive.
As part of the study, in addition to the prehabilitation workshop, we also aim to examine the
potential benefits of a mentored approach, by use of technology and communication.
Our patients often live long distances from the hospital, so frequent hospital visits and
supervised exercise sessions are not plausible. Therefore, a mentored prehabilitation
programme could be considered more practical and generalisable.
We hypothesize that a prehabilitation workshop, and continued patient engagement, has the
potential benefit to improve both the physical and psychological wellbeing of patients
awaiting aortic aneurysm repair.
An initial pilot study examining the study design and deliverability of a mentored approach
prehabilitation programme, is warranted.
References
1. F. Gani et al., "Sarcopenia predicts costs among patients undergoing major abdominal
operations," Surg. (United States), vol. 160, no. 5, pp. 1162-1171, 2016.
2. N. Shah et al., "The association of abdominal muscle with outcomes after scheduled
abdominal aortic aneurysm repair," Anaesthesia, vol. 72, no. 9, pp. 1107-1111, 2017.
3. B. J. Orandi and J. H. Black, "Vascular Surgery," Curr. Surg. Ther., no. March, pp.
777-980, 2013.
4. K. Valkenet, I. G. van de Port, J. J. Dronkers, W. R. de Vries, E. Lindeman, and F. J.
Backx, "The effects of preoperative exercise therapy on postoperative outcome: a
systematic review," Clin. Rehabil., vol. 25, no. 2, pp. 99-111, 2011.
5. C. Li et al., "Impact of a trimodal prehabilitation program on functional recovery after
colorectal cancer surgery: a pilot study and Other Interventional Techniques," Surg
Endosc, vol. 27, pp. 1072-1082, 2013.
6. B. P. Chen et al., "Four-week prehabilitation program is sufficient to modify exercise
behaviors and improve preoperative functional walking capacity in patients with
colorectal cancer," Support. Care Cancer.
7. "Imperial College Healthcare | PREPARE programme." [Online]. Available:
https://www.imperial.nhs.uk/our-services/cancer-services/oesophago-gastric-cancer/prepar
e-programme. [Accessed: 06-Sep-2018].
8. E. Kothmann et al., "Effect of short-term exercise training on aerobic fitness in
patients with abdominal aortic aneurysms: A pilot study," Br. J. Anaesth., vol. 103, no.
4, pp. 505-510, 2009.
9. S. Pouwels, E. M. Willigendael, M. R. van Sambeek, S. W. Nienhuijs, P. W. Cuypers, and
J. A. Teijink, "Beneficial Effects of Pre-operative Exercise Therapy in Patients with an
Abdominal Aortic Aneurysm: A Systematic Review," Eur J Vasc Endovasc Surg, vol. 49, no.
1, pp. 66-76, 2015.
10. G. A. Tew et al., "Randomized feasibility trial of high-intensity interval training
before elective abdominal aortic aneurysm repair," Br. J. Surg., vol. 104, no. 13, pp.
1791-1801, 2017.
11. H. M. Barakat, Y. Shahin, J. A. Khan, P. T. Mccollum, and I. C. Chetter, "Preoperative
supervised exercise improves outcomes after elective abdominal aortic aneurysm repair,"
Ann. Surg., vol. 264, no. 1, pp. 47-53, 2016.
12. J. Myers et al., "A randomized trial of exercise training in abdominal aortic aneurysm
disease," Med. Sci. Sports Exerc., vol. 46, no. 1, pp. 2-9, 2014.
13. P. Banugo and D. Amoako, "Prehabilitation," BJA Educ., vol. 17, no. 12, pp. 401-405,
2017.
14. G. A. Tew, R. Ayyash, J. Durrand, and G. R. Danjoux, "Clinical guideline and
recommendations on pre-operative exercise training in patients awaiting major
non-cardiac surgery," Anaesthesia, vol. 73, no. 6, pp. 750-768, 2018.
Our hypothesis is that a mentored prehabilitation programme will benefit patients having
elective aortic aneurysm surgery. This approach should be tested in a pilot study to ensure
appropriate study design, processes and uptake of the programme by patients.
Primary objectives
To determine the feasibility of delivery of a randomised controlled trial by examining the
following:
1. Feasibility of screening and recruitment. Definition: screening: recruitment ratio of
3:1
2. Subject retention and adherence to 8-week follow up and blinding
Definition:
- Subject wearing activity tracker for greater than 80% of the time.
- 80% or more attendance to 8-week follow up
- 80% or more maintenance of blinding
3. Adherence to trial protocol by comparing weekly physical activity between the three
trial groups.
- Definition: increase in activity in intervention groups of 30% or more compared to the
control group
Secondary objectives
To determine baseline outcome data that may be used to power a full randomised control trial
by examining the following:
1. Composite of post-operative cardiac, respiratory and renal complications at 30 days
Defined as:
Cardiac: MI, new onset arrhythmia, prolonged inotropic support ( > 12 hours post op)
Renal: renal insufficiency needing haemofiltration, >20% increase in creatinine from
baseline.
Respiratory: prolonged intubation > 12 hours, patient needing re- intubation,
post-operative pneumonia
2. Mortality at 30 days
3. Length of hospital stay
4. Quality of life (QoL) EQ-5D—baseline, pre-operative, 6 weeks post-operative
5. Tests of activity and function using the following assessment tools at baseline and
pre-operatively:
- Duke Activity Status Index (DASI) score.
- Time up and Go (TUAG)
- Gait speed
- Leg muscle strength
Study Design This will be a single centre, single blinded, randomised, controlled pilot
study.
Inclusion criteria
• Scheduled for aortic aneurysm surgery
- Ability to walk
- Willingness to wear the activity tracker for 8 weeks.
- Willingness to return at 8 weeks for assessment of secondary outcomes
Exclusion criteria
- Urgent or emergency aneurysm repair
- Patients who undergo emergency admission during the 8-week time frame, will be
removed from the ongoing trial, but their data will be used up to that point.
- Contraindications to exercise
- Severe musculoskeletal disorders preventing exercise
Recruitment
Eligible patients will be identified either from tertiary referrals, or during the
weekly aneurysm multidisciplinary meeting by the aortic clinical nurse specialist (CNS).
The CNS will post the participant information leaflets to eligible participants 2-3
weeks before their first surgical consultation.
The research team will then recruit and consent the participants on the day of their
attendance to the surgical clinic.
The workshop will run on two Fridays a month. The participants will then be randomised
to one of three groups on this date. All recruited participants will be given the
activity monitor and instructed on its use for the study.
The participants recruited into the non-mentored (Arm 2) and mentored (Arm 3)
interventions will then attend the workshop on the next available day. Participants in
arm 3 will be given training on the use of the app.
Participants will be reimbursed for all study-related travel costs.
Randomisation
Recruited participants will be randomised into one of three intervention groups in a
1:1:1 allocation ratio. A block randomisation technique with computer-generated sequence
of random numbers will be produced using Sealed Envelope software
(www.sealedenvelope.com).
Study Arm 1 (Control):
- Current usual practice, no prehabilitation workshop.
Study Arm 2 (non-mentored prehabilitation):
- Prehabilitation workshop with no further patient contact.
- Participants to be given a prehab 'pack' which includes lifestyle advice.
Study Arm 3 (mentored prehabilitation):
- Prehabilitation workshop with regular 'mentoring' up to 8 weeks after the workshop,
prior to their surgery.
- Participants to be given a prehab 'pack' which includes lifestyle advice.
- Weekly phone call by a member of the research team to remind and encourage the
participant to increase activity.
- Participants will be given a smartphone with a 'Prehab Activity' app. This app is
designed and delivered by Medopad (London, UK). The app will include motivational push
notifications, embedded documents and video clips summarising the importance of
prehabilitation and demonstration of exercises.
- The participants in this group will receive training in how to use the app by the
research team.
- Participants will have the opportunity to access expert advice from a designated
physiotherapist in normal working hours.
Medopad is a software company which provides health information and a learning platform
for patients. All data is anonymised and the clinicians will be able to view any
comments made by the participants (using their ID only) - this will be cleared once the
participant finishes the trial.
Medopad will receive anonymised feedback from participants via the research team.
Activity Trackers All patients are to have their activity levels tracked by an Actiwatch
Spectrum (PHILIPS Healthcare, Eindhoven, Netherlands) activity tracker. This is a
lightweight, waterproof, wrist-worn device. All data will be stored on the trackers and
downloaded anonymously onto secure research computers for analysis.
Outcome assessors will be blinded to the intervention.
Follow up
Patients will be followed at two time points in the trial, prior to surgery after the
eight-week intervention period (Follow up 1) and six weeks post-operatively (Follow up
2).
Follow up 1: Eight weeks after recruitment, prior to surgery
- The participant will be requested to attend St Thomas' Hospital to complete a QoL
questionnaire and functional assessments.
- The outcome assessor will remain blinded to the group allocation of the
participant.
Follow up 2: Six weeks postoperative Subjects will be contacted to complete a QoL
questionnaire. Electronic patient records and discharge letters will be used to collect
data on post-operative complications, 30-day mortality and length of hospital stay.
Data Recording All data will be recorded onto paper CRFs which will then be transferred
onto CASTOR database.
Data collection
Demographics Co-morbidities Size and type of aneurysm Surgical method
Baseline data: Day 1; Surgical Consultation Co-morbidities Renal function QoL: EQ-5D
Functional assessment:
- Duke Activity Status Index Score
- Gait speed
- 'Timed up and Go'
- Hip flexion strength
8 weeks: After the surgical OPA, before surgery. Repeat of the functional
assessments and QoL assessment.
Postoperative data:
- Composite of post-operative cardiac, respiratory and renal complications at 30 days
- Death at 30 days
- Length of hospital stay
- EQ-5D
Overall Status
Recruiting
Start Date
2019-11-15
Completion Date
2021-06-01
Primary Completion Date
2021-05-01
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
Feasibility of screening and recruitment: recruitment ratio |
18 months |
Subject retention and adherence to 8-week follow up and blinding |
8 weeks |
Adherence to trial protocol by comparing weekly physical activity between the three trial groups. |
18 months |
Secondary Outcome
Measure |
Time Frame |
Composite of post-operative cardiac complications at 30 days |
30 days post surgery. |
Composite of post-operative respiratory complications at 30 days |
30 days post surgery |
Composite of post-operative renal complications at 30 days |
30 days post surgery |
Mortality at 30 days |
30 days post surgery |
Length of hospital stay |
18 months |
Quality of life (QoL) EQ-5D |
18 months |
Tests of activity and function |
8 weeks |
Tests of activity and function |
8 weeks |
Tests of activity and function |
8 weeks |
Tests of activity and function |
8 weeks |
Enrollment
45
Condition
Intervention
Intervention Type
Behavioral
Intervention Name
Description
A combination of on off workshop and mentored prehabilitation
Arm Group Label
Group 2
Group 3- Mentored group
Eligibility
Criteria
Inclusion Criteria:
- • Attending GSTT for aortic aneurysm surgery
- Ability to walk (determined by ability to perform gait speed independently)
- Willingness to wear the activity tracker for 8 weeks.
- Willingness to return at 8 weeks for re-assessment of secondary outcome measures
Exclusion Criteria:
- Urgent or emergency aneurysm repair
- Patients who undergo emergency admission during the 8-week time frame, will be
removed from the ongoing trial, but their data will be used up to that point.
- Contraindications to exercise (doesn't apply for short term illness ( appendix
4).
- Severe musculoskeletal disorders preventing exercise
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
Accepts Healthy Volunteers
Overall Official
Last Name |
Role |
Affiliation |
Heena Bidd |
Study Chair |
Guys & St Thomas' NHS Foundation Trust |
Overall Contact
Location
Facility |
Status |
Contact |
Guy's and St Thomas' NHS Foundation Trust London SE1 7RT United Kingdom |
Recruiting |
Location Countries
Country
United Kingdom
Verification Date
2019-12-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keyword
Has Expanded Access
No
Condition Browse
Number Of Arms
3
Arm Group
Arm Group Label
Control arm
Arm Group Type
No Intervention
Description
This arm will not be in the prehabilitation group- as is current standard practice
Arm Group Label
Group 2
Arm Group Type
Active Comparator
Description
This arm will be subject to a one off prehabilitation workshop and provided with a prehab booklet
Arm Group Label
Group 3- Mentored group
Arm Group Type
Experimental
Description
This arm will be subject to a one off workshop and provided with a prehab booklet- and additional mentoring by means of 1. an educational app, 2. push notifications,3. weekly communication with physiotherapy team member.
Firstreceived Results Date
N/A
Overall Contact Backup
Acronym
POWER
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)
Study First Submitted
September 3, 2019
Study First Submitted Qc
November 18, 2019
Study First Posted
November 19, 2019
Last Update Submitted
December 6, 2019
Last Update Submitted Qc
December 6, 2019
Last Update Posted
December 9, 2019
ClinicalTrials.gov processed this data on December 13, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.