Clinical trial NCT04797130: The Effect of Hospital Fit 2.0 on Patients Physical Activity
Official title: The Effect of a Smartphone App With Accelerometer on Patients' Physical Activity: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telemedicine
Internal Medicine
Pulmonary Disease
Keywords: Physical activity
eHealth
Accelerometer
Hospitalization
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: 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 do not use Hospital Fit 2.0 as part of the physiotherapy treatment.

Detailed description: Rationale: Low physical activity (PA) levels are common in hospitalised patients. Digital health tools could be valuable to prevent negative effects of inactivity. We therefore developed Hospital Fit 1.0; a smartphone application with accelerometer, designed for hospitalised patients. It enables objective activity monitoring, provides patients insight in their recovery progress and offers a tailored exercise program. Hospital Fit 1.0 has recently been updated, resulting in the improved Hospital Fit 2.0. Improvements in the accelerometer algorithm are made, a goalsetting and reminder function are added, and data from the app can be linked to the electronic medical record. It is hypothesized that using Hospital Fit 2.0 as part of the physiotherapy treatment of hospitalised patients will 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.

Objective: To investigate if using Hospital Fit 2.0 as part of the usual care physiotherapy treatment 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 usual care physiotherapy treatment.

Study design: Assessor blinded randomised controlled trial. Study population: 78 patients hospitalised equally distributed over the department of Internal Medicine and the department of Pulmonology at the Maastricht University Medical Center.

Intervention (if applicable): PA will be measured with an accelerometer until discharge with a maximum of seven days in all patients. The control group receives usual care physiotherapy (n=39), while the intervention group uses Hospital Fit additionally (n=39).

Main study parameters/endpoints: Primary outcome parameter: time spent walking per day (min). Secondary outcome parameters: time spent standing per day (min.), average time spent standing and walking (min.) measured over total measurement time (max. 7 days), number of transitions per day and average number of transitions measured over total measurement time (max. 7 days), number of times walking longer than 5 minutes per day and the average number measured over total measurement time (max.7 days), number of times sitting/lying longer than 30 minutes per day and the average number measured over total measurement time (max. 7 days) and the mILAS score per day (max. 7 days).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden and risks on patients are minimal. The control group will receive usual care physiotherapy and will wear an accelerometer. The intervention group will use Hospital Fit 2.0 additionally. Wearing a small accelerometer and using Hospital Fit 2.0 should not be a burden to patients. The only burden is the time it take to prepare subjects (install app, explain study). No invasive interventions will take place.

Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 75 years
* Receiving physiotherapy while hospitalised at the department of Internal Medicine department or the department of Pulmonology at the Maastricht University Medical Centre (MUMC+)
* Sufficient understanding of the Dutch language
* Having access to a smartphone
* Able to walk independently 2 weeks before admission, as scored on the Functional Ambulation Categories (FAC \>3)

Exclusion Criteria:

* A contraindication to walking (as reported by the attending medical specialists in the medical record)
* A contraindication to wearing an accelerometer, fixed by a hypoallergenic plaster at the upper leg (such as active bilateral upper leg infection, severe edema or bilateral transfemoral amputation)
* Admission at the intensive care department
* Impaired cognition (delirium / dementia) as reported by the attending doctor
* Incapacitated subjects as reported by the attending medical specialist in the medical record. When any doubt arises, the patient will not be considered eligible
* A life expectancy shorter than 3 months as mentioned by the attending medical specialist in the medical record
* Previous participation in this study

Primary outcomes:
measure: Time spent walking per day (min.)
timeFrame: Period between inclusion and discharge, with a maximum of seven days
Secondary outcomes:
measure: Average time spent walking
timeFrame: Period between inclusion and discharge, with a maximum of seven days
measure: Time spent standing per day (min.)
timeFrame: Period between inclusion and discharge, with a maximum of seven days
measure: Average time spent standing
timeFrame: Period between inclusion and discharge, with a maximum of seven days
measure: Number of transitions from a sedentary position (lying or sitting) to an active position (standing or walking) per day
timeFrame: Period between inclusion and discharge, with a maximum of seven days
measure: Average number of transitions from a sedentary position (lying or sitting) to an active position (standing or walking)
timeFrame: Period between inclusion and discharge, with a maximum of seven days
measure: Number of times walking longer than five minutes
timeFrame: Period between inclusion and discharge, with a maximum of seven days
measure: Average number of times walking longer than 5 minutes
timeFrame: Period between inclusion and discharge, with a maximum of seven days
measure: Number of times sitting/lying longer than 30 minutes
timeFrame: Period between inclusion and discharge, with a maximum of seven days
measure: Average number of times sitting/lying longer than 30 minutes
timeFrame: Period between inclusion and discharge, with a maximum of seven days
measure: mILAS score per day
timeFrame: Period between inclusion and discharge, with a maximum of seven days
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: MaastrichtUMC
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Antoine F Lenssen, Prof, PhD
role: PRINCIPAL_INVESTIGATOR
References: