Trial Title:
Assessment, Monitoring and Optimisation of Prehabilitation Patients Using Wearable Fitness Trackers
NCT ID:
NCT06071650
Condition:
Cancer
Conditions: Keywords:
preoperative exercise
prehabilitation
activity tracker
kinesiotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
A prospective, two-arm randomised parallel group clinical trial. Prehabilitation is
routinely offered as the standard of care to all patients who are scheduled for curative
resectional surgeries for upper gastrointestinal (UGI) cancer at Imperial College
Healthcare Trust and lung cancer at Guy's and St Thomas' NHS Foundation Trust.
Consecutive patients referred for prehabilitation will be approached for enrolment into
the study. If willing to participate, written informed consent will be gained
(e-consent). Following enrolment all participants will be provided with a wearable
fitness tracker and will be randomised to one of two groups (1:1 randomisation) - Group A
or Group B. The only difference between the two groups is the prescription of exercise,
all other activities and data collected are the same.
Randomisation following recruitment and using a computer programme.
Primary purpose:
Other
Masking:
None (Open Label)
Masking description:
Because of the nature of the study and the interventions offered, it will not be possible
to blind participants or research assistants to allocation groups.
Intervention:
Intervention type:
Behavioral
Intervention name:
Exercise to a Heart Rate (HR) Zone
Description:
Participants prescribed moderate intensity aerobic exercise using personalised heartrate
zones with a goal of sustaining an intensity level by maintaining their heartrate above
50 percent of their heartrate reserve level for their prescribed duration
Arm group label:
Group B - Exercise to a Heart Rate (HR) Zone - "Intervention Group"
Summary:
Prehabilitation is the use of exercise prior to surgery to improve peoples' fitness,
which leads to improved outcomes of surgery. This service is now being run remotely,
however, there is little existing evidence to support the best practice for this.
Currently, baseline fitness is assessed remotely using either a sit to stand test or a
step test. Once completed people are prescribed regular exercises and asked to exercise
to a level of intensity using a measure called Rating of Perceived Exertion (RPE).
However, these measurements may not be reliable. We are carrying out a study to assess if
another waking test (modified Rockport test) and asking patients to exercise to a target
heart rate are better measures of assessing baseline fitness and exercise intensity.
All participants will receive weekly telephone calls to check their progress and be
provided with a wrist worn fitness tracker (Fitbit). Participants will be randomised to
one of two groups. The only difference between the groups will be the way the exercise is
prescribed. In one group participants will be asked to complete the exercises to an
exercise level they find "somewhat hard". The other group will be asked to complete the
exercises to maintain a set heart rate.
All participants will be asked to complete an activity log (submitted weekly) as an
online form. A small group of people (maximum 10) will be asked if they would like to
complete an in-person baseline fitness assessment also, this is optional.
This study runs for up to eight weeks with participation ending after eight weeks or at
the time of surgery, whichever is sooner. In the final week of participation,
participants will be asked to complete an online questionnaire about their experience of
using a wearable fitness tracker during the prehabilitation programme.
Detailed description:
Optimising patients pre-operatively or "Prehabilitation" is a relatively new and evolving
concept in patient care. Prehabilitation utilises prescribed exercise in the time prior
to surgery with the aim of improving a patient's functional capacity enabling them to
better withstand the stress of surgery. 1-3 This is required due to the physiological
insult cause by surgery, particularly in those with cancer, which in turn results in a
decline in patients' function.
Post-operative restorative rehabilitation programmes such as Enhanced Recovery After
Surgery (ERAS) are commonplace and used with the aim of returning the patients' function
towards their preoperative baseline. ERAS has been shown to improve postoperative
outcomes, including length of stay, re-admission, and complication rates.4
Prehabilitation has been shown to both improve cardiovascular fitness prior to surgery5,6
and like ERAS reduce post-operative complications.7,8 However, despite this and unlike
ERAS, it's use is still patchy, with no national protocols in existence.
Due to evidence demonstrating its effectiveness, the benefits of commissioning
prehabilitation services have been acknowledged in several surgical fields,9 with
national policy documents from NHS England placing an emphasis on preventative
rehabilitation, delivered before and during cancer treatment.10 As such, the policy
environment could be seen as favourable. However, there is little evidence available, and
significant heterogeneity in that which is available, for how best to approach a
prehabilitation service to achieve the best results.
Physical activity is a core component seen across all reported prehabilitation
programmes. However, heterogeneity is seen across multimodal programmes, meaning the type
of exercise, duration and supervision of physical activity is inconsistently administered
between studies. Additional interventions such as dietary support, psychological
wellbeing and smoking cessation are also variably addressed in some studies.
Accurate, reliable, and reproducible assessment of cardiopulmonary fitness is required to
effectively prescribe and monitor patients as they progress through a prehabilitation
programme. Currently, cardiopulmonary fitness assessment requires patients to attend for
in person assessment to undergo Maximal or Submaximal exercise testing.
WEARABLE ACTIVITY TRACKING AND EHEALTH TECHNOLOGIES IN HEALTHCARE
Wearable "fitness tracking" technologies incorporating sensors which monitor activity and
physiological parameters are now pervasive and are a rapidly expanding commercial
industry worldwide with a market size valuation of USD 37.10 billion in 2020, and a
projected compound annual growth rate of 15.9% from 2020 to 2027.11 With significant
investment in this technology leading to increasing functionality, reliability and
aesthetics it opens up the potential for use in a healthcare setting where to date their
use has already been shown to be both feasible and insightful in the perioperative
setting.12 Intuitively, these devices could provide a beneficial aid in prehabilitation
programmes. However, a literature review found no studies have yet reported the use of
wearable technologies on patients when used within a prehabilitation programme.
eHealth technologies are defined as the cost-effective and secure use of information and
communications technologies in support of health and health-related fields13. They are
already widely used by patients with 72% of internet users saying they looked online for
health information of one kind or another within the past year14 and 69% of adults
regularly tracking a health indicator like weight, diet, exercise routine, or symptom15.
Utilising eHealth technology within prehabilitation may help to improve patient
participation, particularly in home-based programmes. The assessment of exercise
intensity is one possible area in which it could be used to overcome the limitations of
self-assessment. Making it easier for patients to assess intensity and monitor the
frequency that they are achieving their target activity may improve exercise behaviour
and consequently improve the response to prehabilitation.
RATIONALE FOR CURRENT STUDY
Using fitness trackers in prehabilitation opens up the potential for remote programmes
whilst maintaining objective measurement of heart rate and step count. Remote
prehabilitation programmes, as opposed to in person individual or group sessions within a
hospital setting are attractive to patients, health professionals and policy makers
alike. For patients, the distance from home and the physical and financial demands of
travel can negatively impact accessibility of programmes and the time available to
complete exercises. Particularly pertinent for those travelling long distances to
tertiary centres for cancer treatment and more recently with the risks of COVID-19 to
those clinically vulnerable. Therefore, reducing unnecessary hospital visits is
desirable. Remote assessment makes scheduling easier for clinicians and the use of
wearable fitness trackers provides a more detailed understanding of individual parameters
over longer periods, rather than a snapshot. For policy makers, remote assessment means
reduced clinic and or gym space required, therefore reducing costs and reduced footfall
(a key target resulting from the covid-19 pandemic) within the hospital to facilitate
other scheduling commitments. Whilst many perceived benefits exist, it is also necessary
to acknowledge that the use of fitness trackers and remote assessment may not benefit
all, an area which will be addressed in this work. Whilst many remote programmes do now
exist, the use of fitness trackers to support these programmes has not been assessed.
Exercise intensity Many reported programmes use a measure called Rating of Perceived
Exertion (RPE) to measure exercise intensity. RPE is a widely used and validated scale
that has been shown to accurately correspond to intensity measured by maximum heart rate
(HRmax) in many different populations.16-18 However, as a self-reported measure, it is
inherently prone to measurement bias; a preliminary study found that over 60% of RPE
measurements made by patients during prehabilitation were overestimates of the actual
achieved intensity measured by achieved heart rate. It is therefore proposed that using
fitness trackers individuals could exercise to prescribed heart rate zones to improve
achievement of their exercise targets. A heart rate zone is a range of heart rates which
corresponds to a desired training effect for an individual. They can be calculated as a
percentage of the heart rate reserve (HRR) which is the maximum heartrate (HRmax) an
individual can achieve minus their resting heartrate (RHR).
Existing prehabilitation programs prescribe the intensity of aerobic exercises to
patients by asking them to exercise to a rating of perceived exertion (RPE). As a
self-reported measure, there is an inherent propensity towards measurement bias, with
studies reporting over 60% of RPE measurements made by patients during prehabilitation as
overestimates of the actual intensity achieved when measured by their heart rate.
Therefore, I hypothesise that prescribing to a heart rate zone and providing a heart rate
tracker to monitor this will increase the levels of moderate intensity exercise achieved.
Self-reporting and Adherence
Direct links have been reported between the amount of physical activity completed each
week and post operative outcomes (lower risk of post-operative pneumonia with increasing
volumes of activity completed in the pre-operative period). 19 However, current
programmes are reliant on self-reported adherence, making assessment of the true benefits
challenging. A previous study of the PREPARE programme found an average adherence of 64%
to the prescribed exercise.20 Adherence to home-based exercises is often lower than
supervised programmes 21 and exercise participation during chemotherapy is particularly
challenging.22 It is therefore important to explore ways to remotely support and
encourage patients to follow their exercise programmes during prehabilitation. Fitness
trackers provide a potential objective measurement of adherence to prescribed targets.
It is beneficial to provide home (vs. hospital) based exercise programmes. However, their
effectiveness dependent on patients' adherence to the prescribed physical exercises
(currently self-reported via an activity log), where activity is frequently
over-reported. Heart rate trackers provide data on activity level and therefore can be
used remotely to determine compliance.
Patient satisfaction of using fitness trackers
Whilst the theory of using fitness trackers in remote prehabilitation is attractive, it
is only beneficial if the target population are engaged, willing and able to use the
devices for the desired purposes. It is important to acknowledge that the demographics of
those undertaking prehabilitation for OG, HPB and LC resections may not be representative
of the average and could find the use of these technologies challenging.
There is no current evidence to demonstrate that patients find the use of wearable
fitness trackers in prehabilitation acceptable. The benefits of using wearable fitness
trackers in prehabilitation will be reduced if compliance with the device is low (i.e.,
they do not wear them). Therefore, there is a need to assess the acceptability,
usability, and user experience of using heart rate trackers in a prehabilitation setting.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age 18 - 80 years.
- New diagnosis of non-metastatic oesophago-gastric (OG), hepatobiliary (HPB) or Lung
Cancer (LC) being offered surgical resection with curative intent at Imperial
College NHS Healthcare Trust (OG/HPB) or Guy's and St Thomas' Hospital (LC).
- Proficient in English
- Enrolled in a prehabilitation programme.
- Capable of providing informed consent and willing to comply with all parts of the
protocol.
Exclusion Criteria:
- Unable to provide informed consent.
- Non-resectable disease.
- Declined surgery.
- No access to smart phone/tablet or internet
- Involved in other current research or have recently been involved in any research
prior to recruitment
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Guy's and St Thomas' NHS Foundation Trust
Address:
City:
London
Zip:
SE1 7EH
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Nigel JM Noor
Phone:
07905000796
Email:
Nigel.Noor@nhs.net
Contact backup:
Last name:
Leanne Ashrafian
Email:
Leanne.Ashrafian@gstt.nhs.uk
Facility:
Name:
Imperial College Healthcare NHS Trust
Address:
City:
London
Zip:
W2 1NY
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Nigel JM Noor
Phone:
07905000796
Email:
Nigel.Noor@nhs.net
Contact backup:
Last name:
Krishna Moorthy
Phone:
02033126515
Email:
k.moorthy@imperial.ac.uk
Start date:
February 27, 2023
Completion date:
April 2024
Lead sponsor:
Agency:
Imperial College London
Agency class:
Other
Collaborator:
Agency:
Imperial College Healthcare NHS Trust
Agency class:
Other
Collaborator:
Agency:
Guy's and St Thomas' NHS Foundation Trust
Agency class:
Other
Source:
Imperial College London
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06071650
