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Completed

NCT Number: NCT04797130

The Effect of Hospital Fit 2.0 on Patients Physical Activity

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MaastrichtUMC

Maastricht, Limburg, 6229 HX, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hospital Fit 2.0

Device

HF consists of a smartphone app combined to an accelerometer. HF provides patients and physiotherapists direct feedback on patients' physical activity behavior.. Individual goals regarding the number of minutes per day spent walking can be set by the therapist. HF also shows patients insight into their own recovery progress. During every treatment, the physiotherapist will evaluate the extent of functional recovery. In addition, Hospital Fit will give physiotherapists the option of creating a patient-specific exercise program supported by videos. During every treatment session, the patient and physiotherapist will evaluate (and if necessary adapt) the amount of activity performed since the previous treatment, the extent of functional recovery and the exercise program.

Primary outcomes

  1. Time spent walking per day (min.)

    Time frame: Period between inclusion and discharge, with a maximum of seven days

    Defined as the total number of minutes walking per day.

Secondary outcomes

  1. Average time spent walking

    Time frame: Period between inclusion and discharge, with a maximum of seven days

    Defined as the total number of minutes walking divided by the total number of valid measurement days in the period between inclusion and discharge, with a maximum of seven days

  2. Time spent standing per day (min.)

    Time frame: Period between inclusion and discharge, with a maximum of seven days

    Defined as the total number of minutes walking per day.

  3. Average time spent standing

    Time frame: Period between inclusion and discharge, with a maximum of seven days

    Defined as the total number of minutes standing divided by the total number of valid measurement days in the period between inclusion and discharge, with a maximum of seven days

  4. Number of transitions from a sedentary position (lying or sitting) to an active position (standing or walking) per day

    Time frame: Period between inclusion and discharge, with a maximum of seven days

    Defined as the total number of transitions from being sedentary (lying or sitting) to being physically active (standing or walking) per day

  5. Average number of transitions from a sedentary position (lying or sitting) to an active position (standing or walking)

    Time frame: Period between inclusion and discharge, with a maximum of seven days

    defined as the total number of transitions divided by the total number of valid measurement days in the period between inclusion and discharge with a maximum of seven days

  6. Number of times walking longer than five minutes

    Time frame: Period between inclusion and discharge, with a maximum of seven days

    Defined as the total number of times per day a patient spent walking for more than 5 minutes continuously without being interrupted by a standing or sedentary activity

  7. Average number of times walking longer than 5 minutes

    Time frame: Period between inclusion and discharge, with a maximum of seven days

    Defined as the total number of times per day a patient spent walking for more than 5 minutes continuously without being interrupted by a standing or sedentary activity, divided by the total number of valid measurement days in the period between inclusion and discharge, with a maximum of seven days

  8. Number of times sitting/lying longer than 30 minutes

    Time frame: Period between inclusion and discharge, with a maximum of seven days

    Defined as the total numer of times per day a patient spent more than 30 minutes lying and/or sitting without interrupting this behavior with a standing or walking activity.

  9. Average number of times sitting/lying longer than 30 minutes

    Time frame: Period between inclusion and discharge, with a maximum of seven days

    Defined as the total numer of times per day a patient spent more than 30 minutes lying and/or sitting without interrupting this behavior with a standing or walking activity, divided by the total number of valid measurement days in the period between inclusion and discharge, with a maximum of seven days

  10. mILAS score per day

    Time frame: Period between inclusion and discharge, with a maximum of seven days

    Defined as the modified Iowa Level of Assistance Score per day

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

The Effect of a Smartphone App With Accelerometer on Patients' Physical Activity: a Randomised Controlled Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 15, 2021
Registry last updated
Sep 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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