Cardiovascular DiseasesNCT05378724
Effectiveness of Hospital Fit on Physical Activity of Hospitalised Patients
A study testing Hospital Fit 2.0, HFITAPP0, release 05, Maastricht Instruments B.V., the Netherlands in people with Cardiovascular Diseases and Oncology, run by Maastricht University Medical Center at 2 sites in Netherlands.
Trial summary
The primary objective of this study is to investigate the effectiveness of using Hospital Fit as part of the physiotherapy treatment on average time spent walking per day in patients hospitalised at the Medical Oncology or Cardiology Departments of the Maastricht University Medical Center (MUMC+) and Radboud… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Oncology, Activation, Patient
- What is being tested?
- Hospital Fit 2.0, HFITAPP0, release 05, Maastricht Instruments B.V., the Netherlands
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Aug 2022to 31 Mar 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old.
- Receiving physiotherapy at the Medical Oncology Department or the Cardiology Department at the MUMC+ or Radboudumc.
- Enough understanding of the Dutch language.
- Owning a smartphone (operating system: at least iOS 13.0 or Android 8.0).
- Able to use a smartphone app.
- Able to walk independently 2 weeks before admission, as scored on the Functional Ambulation Categories (FAC >3).
- Employed as physiotherapist, nurse or physician (assistant) at the Medical Oncology Department or the Cardiology Department.
- Working at the MUMC+ or Radboudumc for at least one month.
Who cannot join
- A contraindication to walking (as reported by a medical specialist in the electronic medical record).
- A contraindication to wearing an activity monitor, fixed by a hypoallergenic plaster at the upper leg (such as active bilateral upper leg infection, severe oedema or bilateral transfemoral amputation).
- Admitted for cancers of the head and neck (i.e., cancer in the oral cavity, throat (pharynx), voice box (larynx), paranasal sinuses and nasal cavity, salivary glands).
- Admitted with cardiac arrhythmia and hemodynamic instability requiring medication over 48 hours (i.e., beta blockers or noradrenaline) or invasive treatment (i.e., pacemaker or defibrillator implementation).
- Mentally incapacitated subjects as reported by healthcare professionals in the medical record. When any doubt arises, the patient will be excluded.
- Impaired cognition (delirium / dementia) as reported in the medical record by a healthcare professional. When any doubt arises, the patient will be excluded.
Show all 10Show fewer
- Unable to participate in the informed consent procedure or unable to provide written informed consent.
- A life expectancy shorter than 3 months as mentioned by the medical specialist in the medical record.
- Previous participation in this study.
- No participation in care for patients at the Medical oncology Department or Cardiology Department during the intervention phase (e.g., absence or research employment).
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
MaastrichtUMC
Maastricht, Limburg, 6229 HX
Radboudumc
Nijmegen, Gelderland, 6525 EZ
About this study
Official title: Effectiveness of Hospital Fit on Physical Activity of Hospitalised Patients: a Stepped-wedge Cluster-randomised Clinical Trial and Process Evaluation
The primary objective of this study is to investigate the effectiveness of using Hospital Fit as part of the physiotherapy treatment on average time spent walking per day in patients hospitalised at the Medical Oncology or Cardiology Departments of the Maastricht University Medical Center (MUMC+) and Radboud University Medical Center (Radboudumc) compared to patients who received physiotherapy before implementation of Hospital Fit. Secondary: to investigate the effectiveness of using Hospital Fit as part of the physiotherapy treatment on average time spent standing per day, average time spent lying/sitting per day, average number of transitions per day and the Modified Iowa Level of Assistance scale (mILAS) scores in hospitalised patients. Besides, the reach, efficacy, adoption, and implementation of using Hospital Fit as part of the physiotherapy treatment will be investigated from the perspective of both patients and healthcare professionals.
Read the detailed description
Rationale: Physical inactivity is a major, underrecognised problem in patients during their hospital stay. Patients spend between 87 and 100% of their time lying or sitting. This physical inactivity has been associated with adverse outcomes such as functional decline, increased length of hospital stay and mortality. Digital health tools could be valuable to prevent negative effects of inactivity. Hospital Fit is a promising app-based intervention to stimulate physical activity by 1) continuous physical activity monitoring, 2) personalised goalsetting, 3) providing patients insight in their functional recovery, 4) providing patients tailored exercise programs, 5) informing patients about benefits of physical activity, and 6) reminding patients to use Hospital Fit 7) linking the data to the electronic medical record, making it available for other healthcare professionals.
Objectives: Primary: to investigate the effectiveness of using Hospital Fit as part of the physiotherapy treatment on average time spent walking per day in patients hospitalised at the Medical Oncology or Cardiology Departments of the Maastricht University Medical Center (MUMC+) and Radboud University Medical Center (Radboudumc) compared to patients who received physiotherapy before implementation of Hospital Fit. Secondary: 1) to investigate the effectiveness of using Hospital Fit as part of the physiotherapy treatment on average time spent standing per day, average time spent lying/sitting per day, average number of transitions per day and the Modified Iowa Level of Assistance scale (mILAS) scores in hospitalised patients; and 2) to investigate the reach, efficacy, adoption, and implementation of using Hospital Fit as part of the physiotherapy treatment from the perspective of both patients and healthcare professionals.
Study design: A prospective, multi-centre, stepped-wedge cluster randomised trial will be performed to investigate the effectiveness of Hospital Fit. Additionally a process evaluation will be performed using questionnaires and semi-structured interviews in patients and focus-group interviews in healthcare professionals.
Study population: In total 180 patients hospitalised at the Medical Oncology Department or Cardiology Departments at the MUMC+ or Radboudumc will be included to study the effectiveness. The process evaluation will be performed in the intervention group using a questionnaire in all 90 patients, semi-structured interviews in 24 purposefully selected patients (or less if data saturation is reached), and focus group interviews in 24 healthcare professionals (i.e., physiotherapists, nurses, and physicians (assistants).
Intervention: Physical activity will be measured in all patients with an accelerometer until discharge with a maximum of nine days. The control group will receive usual care physiotherapy (n=90), while the intervention group will use Hospital Fit additionally (n=90).
Main study parameters/endpoints: Primary outcome parameter: average time spent walking per day (min). Secondary outcome parameters: average time spent standing and lying/sitting per day (min.), average number of transitions from lying/sitting to standing/walking per day, and mILAS score per day. Outcome parameters process evaluation: participation; representation; perceived efficacy; use of app; use of different functionalities; barriers and facilitators to Hospital Fit use; and expected maintenance.
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 additionally. Wearing a small accelerometer and using Hospital Fit should not be a burden to patients. The only burden is the time it takes to prepare subjects (install app, explain study). No invasive interventions will take place. Anticipated benefits of Hospital Fit use include improved physical activity, therewith reducing the negative effects associated with low physical activity.
- Conditions
- Cardiovascular Diseases, Oncology, Activation, Patient
- Being tested
- Hospital Fit 2.0, HFITAPP0, release 05, Maastricht Instruments B.V., the Netherlands
- Keywords
- Physical activity, eHealth, Accelerometer, Hospitalization, Effectiveness, Process evaluation
- Medical subject headings
- Cardiovascular Diseases, Neoplasms, Patient Participation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital Fit 2.0, HFITAPP0, release 05, Maastricht Instruments B.V., the NetherlandsDevice
Hospital Fit consists of a smartphone app combined to the MOX accelerometer. Hospital Fit 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. Hospital Fit also gives patients insight into their own recovery process. During every treament, 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 will receive usual care physiotherapy treatment. 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. Usual care physiotherapy sessions wil take approximately 20-30 minutes per session. They receive no additional intervention and will not use Hospital Fit as part of their physiotherapy treatment. The patients in the control group will receive an activity monitor to collect data about their physical activity levels. However, patients and their healthcare professionals will not receive feedback on patients' physical activity levels. |
| Intervention group | Experimental | Patients in the intervention group will receive usual care physiotherapy and us Hospital Fit additionally. At the end of the last physiotherapy treatment session before discharge, or after a maximum of nine days of study inclusion (whichever comes first), the physiotherapist will remove the activity monitor and data collection will end. Receives: Device: Hospital Fit 2.0, HFITAPP0, release 05, Maastricht Instruments B.V., the Netherlands |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average time spent walking per day (minutes).
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 nine days.
Measured: Period between inclusion and discharge, with a maximum of nine days.
Secondary outcomes (4)
Average time spent standing per day (minutes).
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 nine days.
Measured: Period between inclusion and discharge, with a maximum of nine days.
Average time spent lying/sitting per day (minutes).
Total number of minutes lying/sitting divided by the total number of valid measurement days in the period between inclusion and discharge, with a maximum of nine days.
Measured: Period between inclusion and discharge, with a maximum of nine days.
Average number of transitions per day from a sedentary position (lying or sitting) to an active position (standing or walking).
Total number of transitions divided by the total number of valid measurement days in the period between inclusion and discharge, with a maximum of nine days.
Measured: Period between inclusion and discharge, with a maximum of nine days.
Modified Iowa Level of Assistance scale (mILAS) scores per day.
The 5-item Modified Lowa Level of Assistance Scale (mILAS) assesses the ability of patients to perform 5 activities of daily living and rates the amount of assistance and type of walking aid needed. Each item has a 7-point rating scale (0-6 points), resulting in total scores ranging between 0-30 points. Higher scores indicate that a patient needs more assistance.
Measured: Period between inclusion and discharge, with a maximum of nine days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start1 Aug 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Sequential
- Model description
- A prospective, multi-center, stepped-wedge cluster-randomised trial will be performed to investigate the effectiveness of Hospital Fit. Additionally, a process evaluation will be performed using semi-structured interviews and questionnaires in patients and focus-group interviews in healthcare professionals.
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center
- Responsible party
- Sponsor
- Investigators
- Antoine F Lenssen, Prof, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378724
- Sponsor's protocol ID
- NL
- Status last verified
- Sep 2022
- First submitted
- 8 Apr 2022
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Hospital Fit on Physical Activity of Hospitalised Patients: a Stepped-wedge Cluster-randomised Clinical Trial and Process Evaluation
- ClinicalTrials.gov ID
- NCT05378724
- Acronym / sponsor ID
- NL
- Conditions
- Cardiovascular Diseases, Oncology, Activation, Patient
- Keywords
- Physical activity, eHealth, Accelerometer, Hospitalization, Effectiveness, Process evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Radboud University Medical Center
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 18 May 2022 (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 the effectiveness of using Hospital Fit as part of the physiotherapy treatment on average time spent walking per day in patients hospitalised at the Medical Oncology or Cardiology Departments of the Maastricht University Medical Center (MUMC+) and Radboud University Medical Center (Radboudumc) compared to patients who received physiotherapy before implementation of Hospital Fit. Secondary: to investigate the effectiveness of using Hospital Fit as part of the physiotherapy treatment on average time spent standing per day, average time spent lying/sitting per day, average number of transitions per day and the Modified Iowa Level of Assistance scale (mILAS) scores in hospitalised patients. Besides, the reach, efficacy, adoption, and implementation of using Hospital Fit as part of the physiotherapy treatment will be investigated from the perspective of both patients and healthcare professionals.
Detailed description
Rationale: Physical inactivity is a major, underrecognised problem in patients during their hospital stay. Patients spend between 87 and 100% of their time lying or sitting. This physical inactivity has been associated with adverse outcomes such as functional decline, increased length of hospital stay and mortality. Digital health tools could be valuable to prevent negative effects of inactivity. Hospital Fit is a promising app-based intervention to stimulate physical activity by 1) continuous physical activity monitoring, 2) personalised goalsetting, 3) providing patients insight in their functional recovery, 4) providing patients tailored exercise programs, 5) informing patients about benefits of physical activity, and 6) reminding patients to use Hospital Fit 7) linking the data to the electronic medical record, making it available for other healthcare professionals.
Objectives: Primary: to investigate the effectiveness of using Hospital Fit as part of the physiotherapy treatment on average time spent walking per day in patients hospitalised at the Medical Oncology or Cardiology Departments of the Maastricht University Medical Center (MUMC+) and Radboud University Medical Center (Radboudumc) compared to patients who received physiotherapy before implementation of Hospital Fit. Secondary: 1) to investigate the effectiveness of using Hospital Fit as part of the physiotherapy treatment on average time spent standing per day, average time spent lying/sitting per day, average number of transitions per day and the Modified Iowa Level of Assistance scale (mILAS) scores in hospitalised patients; and 2) to investigate the reach, efficacy, adoption, and implementation of using Hospital Fit as part of the physiotherapy treatment from the perspective of both patients and healthcare professionals.
Study design: A prospective, multi-centre, stepped-wedge cluster randomised trial will be performed to investigate the effectiveness of Hospital Fit. Additionally a process evaluation will be performed using questionnaires and semi-structured interviews in patients and focus-group interviews in healthcare professionals.
Study population: In total 180 patients hospitalised at the Medical Oncology Department or Cardiology Departments at the MUMC+ or Radboudumc will be included to study the effectiveness. The process evaluation will be performed in the intervention group using a questionnaire in all 90 patients, semi-structured interviews in 24 purposefully selected patients (or less if data saturation is reached), and focus group interviews in 24 healthcare professionals (i.e., physiotherapists, nurses, and physicians (assistants).
Intervention: Physical activity will be measured in all patients with an accelerometer until discharge with a maximum of nine days. The control group will receive usual care physiotherapy (n=90), while the intervention group will use Hospital Fit additionally (n=90).
Main study parameters/endpoints: Primary outcome parameter: average time spent walking per day (min). Secondary outcome parameters: average time spent standing and lying/sitting per day (min.), average number of transitions from lying/sitting to standing/walking per day, and mILAS score per day. Outcome parameters process evaluation: participation; representation; perceived efficacy; use of app; use of different functionalities; barriers and facilitators to Hospital Fit use; and expected maintenance.
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 additionally. Wearing a small accelerometer and using Hospital Fit should not be a burden to patients. The only burden is the time it takes to prepare subjects (install app, explain study). No invasive interventions will take place. Anticipated benefits of Hospital Fit use include improved physical activity, therewith reducing the negative effects associated with low physical activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective, multi-center, stepped-wedge cluster-randomised trial will be performed to investigate the effectiveness of Hospital Fit. Additionally, a process evaluation will be performed using semi-structured interviews and questionnaires in patients and focus-group interviews in healthcare professionals.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –All subjects eligible for inclusion in this study will receive usual care physiotherapy treatment. 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. Usual care physiotherapy sessions wil take approximately 20-30 minutes per session. They receive no additional intervention and will not use Hospital Fit as part of their physiotherapy treatment. The patients in the control group will receive an activity monitor to collect data about their physical activity levels. However, patients and their healthcare professionals will not receive feedback on patients' physical activity levels. |
| Intervention group | Experimental | Device: Hospital Fit 2.0, HFITAPP0, release 05, Maastricht Instruments B.V., the NetherlandsPatients in the intervention group will receive usual care physiotherapy and us Hospital Fit additionally. At the end of the last physiotherapy treatment session before discharge, or after a maximum of nine days of study inclusion (whichever comes first), the physiotherapist will remove the activity monitor and data collection will end. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Over 18 years old.
- Receiving physiotherapy at the Medical Oncology Department or the Cardiology Department at the MUMC+ or Radboudumc.
- Enough understanding of the Dutch language.
- Owning a smartphone (operating system: at least iOS 13.0 or Android 8.0).
- Able to use a smartphone app.
Key exclusion criteria (10 listed)
- A contraindication to walking (as reported by a medical specialist in the electronic medical record).
- A contraindication to wearing an activity monitor, fixed by a hypoallergenic plaster at the upper leg (such as active bilateral upper leg infection, severe oedema or bilateral transfemoral amputation).
- Admitted for cancers of the head and neck (i.e., cancer in the oral cavity, throat (pharynx), voice box (larynx), paranasal sinuses and nasal cavity, salivary glands).
- Admitted with cardiac arrhythmia and hemodynamic instability requiring medication over 48 hours (i.e., beta blockers or noradrenaline) or invasive treatment (i.e., pacemaker or defibrillator implementation).
- Mentally incapacitated subjects as reported by healthcare professionals in the medical record. When any doubt arises, the patient will be excluded.
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 2.0, HFITAPP0, release 05, Maastricht Instruments B.V., the NetherlandsHospital Fit consists of a smartphone app combined to the MOX accelerometer. Hospital Fit 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. Hospital Fit also gives patients insight into their own recovery process. During every treament, 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
Average time spent walking per day (minutes).
Time frame: Period between inclusion and discharge, with a maximum of nine days.
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 nine days.
4 secondary outcomes
Average time spent standing per day (minutes).
Time frame: Period between inclusion and discharge, with a maximum of nine days.
Average time spent lying/sitting per day (minutes).
Time frame: Period between inclusion and discharge, with a maximum of nine days.
Average number of transitions per day 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 nine days.
Modified Iowa Level of Assistance scale (mILAS) scores per day.
Time frame: Period between inclusion and discharge, with a maximum of nine 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 18 Apr 2023.
- 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
2 sites 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, HFITAPP0, release 05, Maastricht Instruments B.V., the Netherlands in people with Cardiovascular Diseases and Oncology, run by Maastricht University Medical Center at 2 sites 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 8 inclusion and 10 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 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Average time spent walking per day (minutes). (time frame: Period between inclusion and discharge, with a maximum of nine 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 18 Apr 2023.