The effect of a smartphone app with accelerometer on patients* physical activity: a randomised controlled trial.

Low physical activity (PA) levels are common during hospitalisation. Patients
spend between 92% and 96% of their time lying or sitting. This sedentary
behaviour has been associated with adverse outcomes such as functional decline,
increased length of stay, increased risk of institutionalization, loss of
independency during activities of daily living, reduced quality of live and
even mortality.
Physiotherapy during hospitalisation is aimed at enhancing PA levels and
stimulating functional recovery of activity of daily living which are essential
in order to function independently at home. Objective insight into the PA
behaviour of patients and strategies aimed at stimulating PA during
hospitalisation are therefore of high importance for physiotherapists. In order
to advise patients effectively on their PA behaviour, continuously PA
monitoring with real-time feedback should be implemented in standard
care.mHealth provides a solution to this issue. mHealth has been defined by the
WHO as *medical and public health practice supported by mobile devices, such as
smartphones, tablets or wireless patient-monitoring sensors* . PA can be
monitored by connecting external wearable devices such as accelerometers,
gyroscopes or pedometers, to a smartphone or tablet via Bluetooth.
Recently, the department of Physiotherapy of Maastricht University Medical
Center (MUMC+) and Maastricht Instruments B.V. developed Hospital Fit 1.0.
Hospital Fit 1.0 consists of a smartphone app connected to the MOX Activity
Monitor and is designed to be used in hospitalised patients. It provides
patients and their physiotherapist feedback on the amount time spent upright
(standing and walking) per day. Additionally, it provides patients insight into
their own recovery progress as well as a tailored exercise program supported by
videos.
A recent study showed that physical activity (time standing + walking) was
increased with 28 minutes in patients who were operated for a total knee/hip
arthroplasty by using Hospital Fit 1.0. This study made suggestions for
improvement of Hospital Fit 1.0. Based on these suggestions, improvements have
been made to Hospital Fit 1.0, resulting in an updated version: Hospital Fit
2.0. Hospital Fit 2.0 contains the following improvements: 1) The algorithm of
the MOX Activity Monitor is improved. It is able to differentiate walking or
shuffling from standing in hospitalised patients. In addition it is able to
detect the number of transitions (sit to stand). 2) A goalsetting function is
added, enabling the physiotherapist to set a goal regarding the number of
minutes spent walking per day. The goal is visible in the app as well as the
percentage of this goal that the patient has achieved up to that moment. 3) A
reminder function is added. Notification messages will be automatically
generated four times per day, informing the patient on what percentage of the
set goal has been achieved up to that moment. 4) Data from the PA overview and
recovery assessment will be automatically sent to the electronic medical record
four times per day, making the information available to nurses and physicians
as well.

The primary objective of this study is to investigate if using Hospital Fit 2.0
as part of the usual care physiotherapy treatment of patients hospitalised at
the department of Internal Medicine and the department of Pulmonology in MUMC+
will result in an increase in the amount of PA performed compared to patients
who did not use Hospital Fit 2.0 as part of the physiotherapy treatment.

Research question:
Does using Hospital Fit 2.0 as part of the physiotherapy treatment of patients
hospitalised at the department of Internal Medicine and the department of
Pulmonology in MUMC+ result in an increase in the amount of PA performed
compared to patients who do not use Hospital Fit 2.0 as part of the
physiotherapy treatment?

This study is an assessor-blinded randomized controlled trial (RCT) performed
at the department of Physiotherapy of the Maastricht University Medical
Center (MUMC+).

All subjects eligible for inclusion in this study receive usual care
physiotherapy as prescribed by the physician and receive an accelerometer,
measuring PA, which is attached by the physiotherapist during the first
treatment.

The control group receives no other additional intervention. The intervention
group additionally use Hospital Fit 2.0. Hospital Fit 2.0 consisting of a
smartphone app combined to an accelerometer. The app contains a separate
interface for patients and physiotherapists, enabling extensive options for
physiotherapists. During the first treatment after having signed informed
consent (IC), the physiotherapist will apply the accelerometer and will assist
the patient with installing the app on the patients* smartphone. The
physiotherapist will subsequently initiate a connection between the
accelerometer and the app by starting a new measurement in the physiotherapist
interface. The physiotherapist will then explain the main functionalities of
Hospital Fit 2.0 and will give the patient a written user manual additionally.
Hospital Fit 2.0 provides patients and their physiotherapists direct feedback
on the number of minutes spent lying/sitting, standing, and walking per day and
an overview per week. The number of transitions from a sedentary
(lying/sitting) to active (standing or walking) position per day, the number of
bouts walking *5 minutes per day and the number of bouts lying/sitting *30
minutes per day are provided as well. A weekly overview can be provided per
parameter if preferred. Individual goals regarding the number of minutes per
day spent walking can be set by the physiotherapist based on the patient*s
abilities and needs. Hospital Fit 2.0 also gives patients the option of gaining
insight into their own recovery progress. During every treatment, the
physiotherapist will evaluate the extent of functional recovery based on the
modified Iowa Level of Assistance Scale (mILAS). The physiotherapist will
subsequently report the extent of functional recovery in the app, therewith
enabling the information to be seen by patients. In addition, Hospital Fit will
give physiotherapists the option of creating a patient-specific exercise
program supported by videos. The patients are free to use the app during the
day. At the end of the last treatment session before discharge, with a maximum
of seven days, the physiotherapist will remove the accelerometer and
participation in this study will end.

The burden and risks of participation in this study are minimal. Participation
in the study will take up approximately 25 minutes for patients in the control
group and 60 minutes for patients in the intervention group. Time spent on
coming to a well-informed decision on whether to participate in the study or
not should be added as well and will differ between patients.

The risk of wearing an accelerometer is minimal. The accelerometer is small and
does not restrict the patient in his daily activities or choice of clothing.
Patients are informed that they are allowed to remove the accelerometer in case
they are bothered in any way. In addition, patients, nurses and
physiotherapists are instructed to take the accelerometer and hypoallergenic
plaster off in case of an MRI or skin irritation. Low risk, minimal burden.

The risks of using Hospital Fit 2.0 are minimal. The activities promoted in
Hospital Fit 2.0 are also performed during the usual care physiotherapy.
Hospital Fit 2.0 aims to improve the amount of PA and improve the
self-management of patients, it does not stimulate patients to do other
exercises than already performed during the physiotherapy treatment. The
physiotherapist creates a tailored exercise program, in which the safety of the
exercises performed is considered.

In conclusion, Hospital Fit use will result in a minimal burden and minimal
risk to the patient.