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The Effect of Hospital Fit 2.0 on Patients Physical Activity

Primary Purpose

Telemedicine, Internal Medicine, Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Hospital Fit 2.0
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Telemedicine focused on measuring Physical activity, eHealth, Accelerometer, Hospitalization

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MaastrichtUMC

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Intervention group

Arm Description

All subjects eligible for inclusion in this study receive usual care physiotherapy as prescribed by the physician. The number of treatment sessions and content of physiotherapy treatment sessions will depend on the diagnosis and needs of the individual patient. This study will not interfere with the content of the usual care physiotherapy treatment. Patients in the control group will receive an accelerometer, measuring PA, which is applied by the physiotherapist during the first treatment. They receive no other additional intervention. Usual care physiotherapy sessions will take approximately 20-30 minutes per session.

Patients in the intervention group will receive usual care physiotherapy and use Hospital Fit 2.0 (HF) additionally. After the last treatment session (max. 7 days), the therapist will remove the accelerometer and participation in the study will end.

Outcomes

Primary Outcome Measures

Time spent walking per day (min.)
Defined as the total number of minutes walking per day.

Secondary Outcome Measures

Average time spent walking
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
Time spent standing per day (min.)
Defined as the total number of minutes walking per day.
Average time spent standing
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
Number of transitions from a sedentary position (lying or sitting) to an active position (standing or walking) per day
Defined as the total number of transitions from being sedentary (lying or sitting) to being physically active (standing or walking) per day
Average number of transitions from a sedentary position (lying or sitting) to an active position (standing or walking)
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
Number of times walking longer than five minutes
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
Average number of times walking longer than 5 minutes
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
Number of times sitting/lying longer than 30 minutes
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.
Average number of times sitting/lying longer than 30 minutes
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
mILAS score per day
Defined as the modified Iowa Level of Assistance Score per day

Full Information

First Posted
March 10, 2021
Last Updated
September 13, 2022
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04797130
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 23, 2021 (Actual)
Primary Completion Date
January 27, 2022 (Actual)
Study Completion Date
January 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Telemedicine, Internal Medicine, Pulmonary Disease
Keywords
Physical activity, eHealth, Accelerometer, Hospitalization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
InvestigatorOutcomes Assessor
Masking Description
Investigators and outcome assessors are blinded for treatment (control group: usual care physiotherapy treatment versus intervention group: usual care physiotherapy treatment and Hospital Fit 2.0 use)
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
All subjects eligible for inclusion in this study receive usual care physiotherapy as prescribed by the physician. The number of treatment sessions and content of physiotherapy treatment sessions will depend on the diagnosis and needs of the individual patient. This study will not interfere with the content of the usual care physiotherapy treatment. Patients in the control group will receive an accelerometer, measuring PA, which is applied by the physiotherapist during the first treatment. They receive no other additional intervention. Usual care physiotherapy sessions will take approximately 20-30 minutes per session.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Patients in the intervention group will receive usual care physiotherapy and use Hospital Fit 2.0 (HF) additionally. After the last treatment session (max. 7 days), the therapist will remove the accelerometer and participation in the study will end.
Intervention Type
Device
Intervention Name(s)
Hospital Fit 2.0
Intervention Description
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 Outcome Measure Information:
Title
Time spent walking per day (min.)
Description
Defined as the total number of minutes walking per day.
Time Frame
Period between inclusion and discharge, with a maximum of seven days
Secondary Outcome Measure Information:
Title
Average time spent walking
Description
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
Time Frame
Period between inclusion and discharge, with a maximum of seven days
Title
Time spent standing per day (min.)
Description
Defined as the total number of minutes walking per day.
Time Frame
Period between inclusion and discharge, with a maximum of seven days
Title
Average time spent standing
Description
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
Time Frame
Period between inclusion and discharge, with a maximum of seven days
Title
Number of transitions from a sedentary position (lying or sitting) to an active position (standing or walking) per day
Description
Defined as the total number of transitions from being sedentary (lying or sitting) to being physically active (standing or walking) per day
Time Frame
Period between inclusion and discharge, with a maximum of seven days
Title
Average number of transitions from a sedentary position (lying or sitting) to an active position (standing or walking)
Description
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
Time Frame
Period between inclusion and discharge, with a maximum of seven days
Title
Number of times walking longer than five minutes
Description
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
Time Frame
Period between inclusion and discharge, with a maximum of seven days
Title
Average number of times walking longer than 5 minutes
Description
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
Time Frame
Period between inclusion and discharge, with a maximum of seven days
Title
Number of times sitting/lying longer than 30 minutes
Description
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.
Time Frame
Period between inclusion and discharge, with a maximum of seven days
Title
Average number of times sitting/lying longer than 30 minutes
Description
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
Time Frame
Period between inclusion and discharge, with a maximum of seven days
Title
mILAS score per day
Description
Defined as the modified Iowa Level of Assistance Score per day
Time Frame
Period between inclusion and discharge, with a maximum of seven days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine F Lenssen, Prof, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MaastrichtUMC
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 HX
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We do not intent to make IPD available to other researchers.

Learn more about this trial

The Effect of Hospital Fit 2.0 on Patients Physical Activity

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