TelemedicineNCT04797130
The Effect of Hospital Fit 2.0 on Patients Physical Activity
A study testing Hospital Fit 2.0 in people with Telemedicine and Internal Medicine, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Telemedicine, Internal Medicine, Pulmonary Disease
- What is being tested?
- Hospital Fit 2.0
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 Mar 2021to 27 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Smartphone App With Accelerometer on Patients' Physical Activity: a Randomised Controlled Trial
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.
Read the 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.
- Conditions
- Telemedicine, Internal Medicine, Pulmonary Disease
- Being tested
- Hospital Fit 2.0
- Keywords
- Physical activity, eHealth, Accelerometer, Hospitalization
- Medical subject headings
- Lung Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital Fit 2.0Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 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. |
| Intervention group | Experimental | 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. Receives: Device: Hospital Fit 2.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent walking per day (min.)
Defined as the total number of minutes walking per day.
Measured: Period between inclusion and discharge, with a maximum of seven days
Secondary outcomes (10)
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
Measured: 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.
Measured: Period between inclusion and discharge, with a maximum of seven days
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
Measured: 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
Measured: Period between inclusion and discharge, with a maximum of seven days
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
Measured: 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
Measured: Period between inclusion and discharge, with a maximum of seven days
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
Measured: 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.
Measured: Period between inclusion and discharge, with a maximum of seven days
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
Measured: 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
Measured: Period between inclusion and discharge, with a maximum of seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start23 Mar 2021
- Primary completion27 Jan 2022
- Study completion27 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelemedicineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine F Lenssen, Prof, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797130
- Sponsor's protocol ID
- NL75126.068.20
- Status last verified
- Sep 2022
- First submitted
- 10 Mar 2021
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not intent to make IPD available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Smartphone App With Accelerometer on Patients' Physical Activity: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04797130
- Acronym / sponsor ID
- NL75126.068.20
- Conditions
- Telemedicine, Internal Medicine, Pulmonary Disease
- Keywords
- Physical activity, eHealth, Accelerometer, Hospitalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 27 Jan 2022 (actual)
- Study completion
- 27 Jan 2022 (actual)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –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. |
| Intervention group | Experimental | Device: Hospital Fit 2.0Patients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hospital Fit 2.0HF 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. | Device | Intervention group |
Primary outcome
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.
10 secondary outcomes
Average time spent walking
Time frame: Period between inclusion and discharge, with a maximum of seven days
Time spent standing per day (min.)
Time frame: Period between inclusion and discharge, with a maximum of seven days
Average time spent standing
Time frame: 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
Time frame: Period between inclusion and discharge, with a maximum of seven days
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
Number of times walking longer than five minutes
Time frame: Period between inclusion and discharge, with a maximum of seven days
Average number of times walking longer than 5 minutes
Time frame: Period between inclusion and discharge, with a maximum of seven days
Number of times sitting/lying longer than 30 minutes
Time frame: Period between inclusion and discharge, with a maximum of seven days
Average number of times sitting/lying longer than 30 minutes
Time frame: Period between inclusion and discharge, with a maximum of seven days
mILAS score per day
Time frame: Period between inclusion and discharge, with a maximum of seven days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Individual participant dataSharing planned: No. We do not intent to make IPD available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine F Lenssen, Prof, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hospital Fit 2.0 in people with Telemedicine and Internal Medicine, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time spent walking per day (min.) (time frame: Period between inclusion and discharge, with a maximum of seven days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.