Feasibility of a Digital Home-Based Supervised Physical Exercise Training Program Before and After Surgical Hip Replacement

Hip osteoarthritis is a debilitating joint disease characterized by the
degradation of articular cartilage and structural damage to the joint. When
conservative interventions such as medications, physical therapy, injections,
and lifestyle modifications are no longer effective, and the condition severely
impairs daily life, total joint replacement surgery is considered. Total hip
arthroplasty (THA) is widely regarded as one of the most effective medical
interventions, providing significant relief from pain and enhancing physical
function and overall quality of life for individuals suffering from severe hip
osteoarthritis [1,2]. In the Netherlands in 2019, 222 per 100.000 inhabitants
underwent hip replacement surgery due to osteoarthritis [3]. However, despite
the apparent effectiveness, between 7% and 23% of patients undergoing THA
experience an unfavourable outcome [4,5].

To enhance the outcomes of total joint replacement, both post-operative and
pre-operative rehabilitation strategies have been proposed. Traditionally,
physiotherapy is administered as post-surgical rehabilitation to expedite
recovery and improve overall outcomes [6,7]. In the Netherlands, the Royal
Dutch Society for Physical Therapy (KNGF) recommends post-operative exercise
therapy for THA, especially for patients at risk for delayed recovery [8]. In
the last decade, preoperative rehabilitation, often referred to as
prehabilitation, has gained significant interest. This aligns with the idea of
better in, better out (BiBo), meaning the better a patient enters a hospital
(*better in*), the better and faster he leaves the hospital (*better out*). In
the Netherlands, an advisory BiBo guideline for physical therapists has been
developed. KNGF guidelines indicate that pre-operative exercise therapy can be
considered before THA [8]. Systematic reviews, although mainly based on small
randomized controlled trials (RCTs), have demonstrated low to moderate evidence
suggesting that preoperative physiotherapy interventions can reduce pain and
enhance functional performance in patients undergoing THA [9-13]. However,
evidence is heterogenic and high quality studies are missing.

Several determinants of success of pre- and postoperative exercise therapy have
been mentioned in literature. Firstly, it is essential to find the optimal
target population, as for example non-participation is high among fragile
elderly [14] and most active patients will probably experience less benefit.
Screening for risk factors can reduce the amount of complications of the
surgery, e.g. function loss, having a delirium or even death. The BiBo
guideline therefore proposes a risk model (based on age, sex, BMI, time of the
Timed Up & Go (TUG) test and the Charnley score) to determine if THA patients
have an increased risk of delayed recovery and are eligible for prehabilitation
[15]. Secondly, the nature of the intervention is a key determinant of
effectiveness. Thus far, pre- and postoperative exercise therapies have been
diverse and often limited in terms of type of exercises and its dosage. It is
essential to ensure an adequate dosage, while simultaneously maintaining high
adherence rates [16]. In their systematic review, Punnoose et al. propose a
minimum of 4-6 weeks and 2 sessions per week of prehabilitation for patients
undergoing orthopedic surgery [11].

Another substantial barrier for pre- and postoperative exercise therapy is
travel burden for patients, especially since patients are not allowed to drive
their car in the first weeks after surgery. Finally, challenges like shortages
in healthcare staff and the general need for reduced healthcare costs,
requires new ways of delivering care. To overcome these challenges,
tele-rehabilitation or a blended care approach might be preferred over a
completely supervised rehabilitation. Home-based or blended care strategies
might result in a reduction of healthcare expenditures and improved adherence
to home-based exercises by incorporating gamification and remote supervision of
a therapist [17-20]. Home-based exercise therapy pre- and postoperatively has
shown to be feasible [21] and as effective as supervised approaches[22-25].
Adding up to this, telerehabilitation achieves non-inferior physical and
functional outcomes as those receiving equal dosage in-person rehabilitation
programmes [26]. At the moment there are new technological developments to
enhance dose and adherence like TRAK. TRAK is a web-based platform that
facilitates remote information provision, making use of an exercise program
with visual feedback and contact with a physiotherapist. A benefit of the
platform is that it uses artificial intelligence (AI) providing real-time
measurements and feedback during performance of exercises [27]. A feasibility
study among 16 patients with knee problems and 15 physiotherapists showed high
usability of a web-based application like the TRAK system [28]. The main goals
of the TRAK system are to enhance the effectiveness of THA in terms of
functional ability and pain in a cost-effective way, speeding up the
rehabilitation process and reducing the need for pain medication and
face-to-face visits with physiotherapists or other health care providers. In
the current study, we aim to enhance outcomes for THA patients at risk for
delayed recovery by providing home-based pre- and postoperative exercise
therapy through the TRAK platform (TRAK intervention) with remote supervision
from a physiotherapist. More information about the use of the TRAK platform is
needed to gain a better understanding of how the intervention can suit patients
and physiotherapists needs and improve likelihood of successful implementation.
Which is why we will investigate the feasibility of the TRAK intervention
before and after surgical hip replacement for both patients and care providers.

The primary objective is to investigate the feasibility of a digital home-based
supervised physical exercise training program through the TRAK platform (TRAK
intervention) before and after surgical hip replacement for both patients and
physiotherapist.

Secondary Objective(s):
- To explore the effectiveness of the TRAK intervention on patient outcomes
before and after the hip replacement surgery
- To assess feasibility of the TRAK intervention within the different phases
(pre- and post-operative therapy)

The study will investigate the feasibility of the TRAK intervention. We will
use Bowen*s feasibility framework to guide data collection in this study, as we
aim to assess multiple focus types of feasibility [29]. The included areas are
acceptability, demand, implementation, integration, practicality and limited
efficacy. Adaptation and expansion were deemed to be not applicable in the
current context. Two types of participants are involved; patients (n = 30) that
are planned to undergo primary hip arthroplasty and at risk for delayed
recovery, and care providers: physiotherapists and orthopedic surgeons.
Patients and care providers will be recruited at the Sint Maartenskliniek.
Patients will receive 6-8 weeks pre- and 8 weeks post-operative exercise
therapy using the TRAK platform (see Figure 1). Usual care mostly consists of
no exercise therapy before surgery, and a referral for 6-12 weeks of
physiotherapy after surgery.
For the patients receiving within the TRAK intervention group, a first
(face-to-face) meeting with the physiotherapist to explain the program and
exercises will be planned at baseline. During the pre- and post-rehabilitation,
physical rehabilitation exercises will be conducted at the patient's home.
Physiotherapists of the Sint Maartenskliniek will monitor the activities of the
patients (through information available on the platform) and contact patients
when needed, for example when patients do not perform their exercises as
scheduled. Therapists will have regular contact moments with patients at least
once per two weeks. Next to this, patients can also contact the physiotherapist
via the app for support. Measurements will be performed at baseline (at least 6
weeks prior to surgery), pre-surgery (4 days before surgery), 8 weeks and 26
weeks post-surgery. This will be a post-market study with a medical device with
CE marking (MDR article 74.1). No other medical devices apply, TRAK is the only
investigational product considered, with its independent use being sufficient
to conduct the intended study.

The TRAK intervention comprises of physiotherapy exercises using the TRAK
platform. The TRAK platforms* intended use is to deploy it as a tracking and
monitoring tool for the patient, enabling them to perform a physical exercise
routine for therapeutic treatment both before and after hip replacement surgery
in a completely digital manner. Patients will be instructed to perform daily
exercises for 6-8 weeks pre-surgery and 8 weeks post-surgery. The execution of
the exercises will be recorded by the patient, and these recordings will be
available for the physiotherapist to conduct monitoring for where help is
needed. The training is based on the training program for knee and hip
osteoarthritis of the KNGF [33]. This program consists of a minimum of two
times a week strength exercises and five times a week at least 30 minutes
aerobics exercises. The TRAK intervention concists of four times a week roughly
20 minutes strength exercises. Within TRAK only the strength exercises are
possible. To comply to the KNGF program, patients will be asked to perform and
write down their aerobics exercises in a journal. The TRAK training program
includes the same exercises/sessions for all the patients, although these can
be personalized timewise or repetition wise based on the capacities and
complaints of the individual patient. Pre-surgery and post-surgery exercises
will be partly the same, although there will be also other exercises
pre-surgery versus post-surgery due to a difference in aim of the training. The
training program is compiled by the physiotherapists of the Sint
Maartenskliniek, and personalized based on the participant*s needs to ensure
favorable progress.
At baseline patients will receive explanation on the TRAK platform from a
researcher. They will also meet the physiotherapist that will walk them through
the exercise program. From baseline onwards patients will have phone contact
(roughly 10 minutes) with the physiotherapist once every 2 weeks to monitor
progress and answer questions.

The TRAK-app is a registered computer program designed for remote monitoring
and functional assessment by the healthcare professional during the
rehabilitation process (self-monitoring) of patients with musculoskeletal
injuries. The subjects recruited for this clinical trial will not be exposed to
any procedures that could endanger their safety as the training exercises are
exercises normally used in usual care. Now patients will do these exercises at
home with an AI based app. Those exercises will be recorded during performing,
with a potential fall during performance as the only possible risk during the
clinical trial. Although this risk is equivalent to performing exercises during
usual care. Patients participating in the clinical trial will be asked to only
come to the hospital one extra time, for the baseline measurement. Adding up to
this, the questionnaires are extra next to the usual surgery standards. This
all makes the clinical trial not that burdensome. With the TRAK intervention
patients are asked to perform (extra) physiotherapy training prior to their
surgery. The gain is that patients will be more fit before the surgery and
after the surgery. This all shows that this clinical trial bares small risks
for patients.