AzTrials
AzTrials

Hospital MobilityINTOMOBNCT05639231

An INtervention TO Improve MOBility of Older Hospitalized Patients

A study testing INTOMOB intervention in people with Hospital Mobility and Mobility Limitation, run by Insel Gruppe AG, University Hospital Bern at 4 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Low mobility during an acute care hospitalization is very frequent, particularly among older patients, and associated with adverse outcomes, such as persistent functional decline, institutionalization and death. However, increasing hospital mobility remains challenging because of the multiple existing barriers. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Hospital Mobility, Mobility Limitation, Life-Space
What is being tested?
INTOMOB intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
383 participants
Where
4 sitesSwitzerland
Study dates
15 Dec 2022to 18 Jul 2025
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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Admission to a general internal medicine (GIM) ward of a participating hospital
  • Age ≥60 years
  • Being ambulatory during the 2 weeks before admission (self-report)
  • Living in the community (not in a nursing home or another institution) for at least the last 30 days prior to admission
  • Ability to understand French or German
  • Planned length of stay at least 3 days after enrollment
  • For the pilot-study only: Possibility to start the study within 48 hours after admission to the GIM ward

Who cannot join

  • Medical contraindication to walk (e.g., wound not allowing loading weight)
  • Wheelchair-bound
  • End-of-life
  • Severe psychiatric disorder (severe depression, schizophrenia, psychosis)
  • Delirium (according to the Confusion Assessment Method [CAM])
  • Additional exclusion criterion for the pilot-study only:
Show all 10Show fewer
  • Dementia (defined as Mini-Cog <3)
  • Additional exclusion criteria for the RCT only:
  • Cognitive impairment making impossible to use study material (=implement the intervention) and to understand and sign informed consent, based on clinical judgement, except if a proxy can be actively involved in the study and provides consent
  • Severe visual impairment

Trial locations and contacts

4 sites in 1 country.

Switzerland4 sites
  • Kantonsspital Baden

    Baden, Canton of Aargau, 5404

  • Spital Tiefenau, InselGruppe AG

    Bern, 3004

  • Inselspital, Bern University Hospital, InselGruppe AG

    Bern, 3010

  • HFR-Fribourg - hôpital cantonal

    Villars-sur-Glâne, Canton of Fribourg, 1752

Other trials in Switzerland

About this study

Official title: Impact of an INtervention TO Increase MOBility in Older Hospitalized Medical Patients (INTOMOB): a Cluster Randomized Controlled Trial

Low mobility during an acute care hospitalization is very frequent, particularly among older patients, and associated with adverse outcomes, such as persistent functional decline, institutionalization and death. However, increasing hospital mobility remains challenging because of the multiple existing barriers.

The goal of this clinical trial is to test the effect of a multilevel intervention to increase hospital mobility, which addresses modifiable barriers and facilitators and does not require unavailable additional resources.

Read more

This study aims to answer whether this intervention can improve mobility and patient-relevant outcomes such as life-space mobility and functional status.

The multilevel intervention will target:

  1. The patients, who will receive an information booklet, a customizable diary, an exercise booklet and an iPad with access to the videos of the exercise booklet.
  2. The healthcare professionals (nursing staff and physicians) who will complete an e-learning, receive an oral presentation on the intervention, and receive a "mobility checklist" that reminds them of what they should assess daily regarding mobility.
  3. The hospital environment, where posters will be hung in the wards, including walking itineraries, on topics of interest to older adults.

In a first phase, the intervention will be pilot-tested in one ward of each hospital. The intervention will then be adapted based on patient and healthcare professional feedback.

In a second phase, the intervention will be tested in a cluster randomized controlled trial, and compared to standard of care.

Being tested
INTOMOB intervention
Keywords
Hospital mobility, Life-Space, Functional status, Hospital-Acquired disability, Exercise, Movement, Ambulation
Medical subject headings
Mobility Limitation, Iatrogenic Disease, Muscular Atrophy, Asthenia, Sarcopenia, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INTOMOB interventionBehavioural

    The intervention will be multilevel, targeting the patients, healthcare professionals (HCPs) and environment:

    PATIENTS:

    • Information booklet on the importance/benefits of mobility, consequences of low mobility, how to be more active (with concrete information).
    • Customizable diary to document mobility goals, results, difficulties and needs.
    • Exercise booklet with explanations \& pictures of mobility exercises (supine, sitting, standing).
    • iPad 10.2'' with videos of the exercises.

    HCPs (physicians \& nursing staff):

    • E-learning on the consequences of low mobility, barriers/facilitators to hospital mobility; recommendations, documentation, communication \& interdisciplinary collaboration regarding mobility; implementation.
    • Oral presentation on the intervention.
    • Checklist to remind HCPs to address mobility.

    ENVIRONMENT:

    • Posters in the wards about mobility and other topics of interest to older adults.
    • Walking itineraries in the wards.
Study groups in NCT05639231
Study groupRoleWhat they receive
INTOMOB interventionExperimentalThe intervention will be multilevel, targeting the patients, healthcare professionals (HCPs) and environment, as described under "Intervention description".
Receives: Behavioral: INTOMOB intervention
ControlNo interventionControl procedure in the randomized trial: * Patients will receive standard of care, including physiotherapy if prescribed by the hospital physician and usual mobility recommendations and support by the HCPs. * HCPs will neither complete the e-learning, nor receive the checklist and the oral presentation. * The environment will not be modified in regards to mobility. Already existing information on this topic (e.g., small posters hanging in patient rooms) will not be removed, since it corresponds to current standard of care in some hospitals. In the pilot study, there will be no control procedure, since the objective is to assess experience and feasibility of the intervention, not its effects.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Life-space level

    Measured by the University of Alabama at Birmingham Study of Aging Life-Space Assessment (range 0-120, with maximum being a higher score = better outcome). For patients institutionalized, assessment through the Life-Space Assessment in Institutionalized Settings. Both scales can be merged since the scoring is similar. Assessment by telephone interview of the participant/relatives.

    Measured: Day 30 (+/-5) after enrollment

Secondary outcomes (46)
  1. Life-space level

    Measured by the University of Alabama at Birmingham Study of Aging Life-Space Assessment (or Life-Space Assessment in Institutionalized Settings for institutionalized patients) by telephone interview of the participant/relatives

    Measured: Day 180 (+/-5) after enrollment

  2. Activities of Daily Living

    Measured by the Barthel Index by telephone interview of the participant/relatives

    Measured: Day 30 (+/-5) after enrollment

  3. Activities of Daily Living

    Measured by the Barthel Index by telephone interview of the participant/relatives

    Measured: Day 180 (+/-5) after enrollment

  4. Instrumental Activities of Daily Living

    Measured by the Lawton Index by telephone interview of the participant/relatives

    Measured: Day 30 (+/-5) after enrollment

  5. Instrumental Activities of Daily Living

    Measured by the Lawton Index by telephone interview of the participant/relatives

    Measured: Day 180 (+/-5) after enrollment

  6. Quality of life (EQ-5D)

    Measured by the European Quality of Life-5 Dimensions (EQ-5D) questionnaire by telephone interview of the participant/relatives

    Measured: Day 30 (+/-5) after enrollment

  7. Quality of life (EQ-5D)

    Measured by the European Quality of Life-5 Dimensions (EQ-5D) questionnaire by telephone interview of the participant/relatives

    Measured: Day 180 (+/-5) after enrollment

  8. Depression

    Measured by the Patient Health Questionnaire (PHQ)-2 by telephone interview of the participant/relatives

    Measured: Day 30 (+/-5) after enrollment

  9. Depression

    Measured by the Patient Health Questionnaire (PHQ)-2 by telephone interview of the participant/relatives

    Measured: Day 180 (+/-5) after enrollment

  10. Pressure ulcer

    Evaluated according to the NPUAP/EPUAP classification, based on nurse report and electronic health record

    Measured: Discharge (-1 to +2 days after discharge)

  11. Delirium during hospitalization (hospitalization duration expected to be 3 to 20 days on average)

    Measured by the Confusion Assessment Method

    Measured: Discharge (-1 to +2 days after discharge)

  12. Mobility at discharge

    Measured by the de Morton Mobility Index (DEMMI); assessment conducted by the study team

    Measured: Discharge (maximum 1 day before)

  13. Lower-limb muscle strength

    Measured by lower-limb manual testing according to the method by Hislop and Montgomery; assessment conducted by the study team

    Measured: Discharge (maximum 1 day before)

  14. Hand-grip muscle strength

    Measured by JAMAR (for the pilot study) and SAEHAN (for the RCT) hand dynamometer; assessment conducted by the study team

    Measured: Discharge (maximum 1 day before)

  15. Step count during hospitalization (hospitalization duration expected to be 3 to 20 days on average)

    Measured by a StepWatch ankle accelerometer or a GENEActiv wrist accelerometer (the choice of the device will be defined after the pilot study during which both accelerometers will be tested)

    Measured: Discharge (hospitalization duration expected to be 3 to 20 days on average)

  16. Level of activity during hospitalization (hospitalization duration expected to be 3 to 20 days on average)

    Measured by GENEActiv wrist accelerometer (only if this accelerometer is chosen after the pilot study)

    Measured: Discharge (hospitalization duration expected to be 3 to 20 days on average)

  17. Fear of / concerns about falling

    Measured by the Falls Efficacy Scale - International by telephone interview of the participant/relatives

    Measured: Discharge (-1 to +2 days after discharge)

  18. Fear of / concerns about falling

    Measured by the Falls Efficacy Scale - International by telephone interview of the participant/relatives

    Measured: Day 30 (+/-5) after enrollment

  19. Fear of / concerns about falling

    Measured by the Falls Efficacy Scale - International by telephone interview of the participant/relatives

    Measured: Day 180 (+/-5) after enrollment

  20. Fall-risk increasing drugs

    Including loop diuretic, beta blocker, cardiac glycoside (digitalis, digoxin), statin, antipsychotic (neuroleptic), tricyclic antidepressant, selective serotonin reuptake inhibitor, other antidepressant, benzodiazepine, opioid, antiepileptic. Assessed through the electronic health record

    Measured: Discharge (discharge letter) (hospitalization duration expected to be 3 to 20 days on average)

  21. Fall-risk increasing drugs during hospitalization

    Including loop diuretic, beta blocker, cardiac glycoside (digitalis, digoxin), statin, antipsychotic (neuroleptic), tricyclic antidepressant, selective serotonin reuptake inhibitor, other antidepressant, benzodiazepine, opioid, antiepileptic. Assessed through the electronic health record

    Measured: Discharge (discharge letter) (hospitalization duration expected to be 3 to 20 days on average)]

  22. Fall-risk increasing drugs

    Including loop diuretic, beta blocker, cardiac glycoside (digitalis, digoxin), statin, antipsychotic (neuroleptic), tricyclic antidepressant, selective serotonin reuptake inhibitor, other antidepressant, benzodiazepine, opioid, antiepileptic. Assessed by telephone interview of the participant

    Measured: Day 30 (+/-5) after enrollment

  23. Fall-risk increasing drugs

    Including loop diuretic, beta blocker, cardiac glycoside (digitalis, digoxin), statin, antipsychotic (neuroleptic), tricyclic antidepressant, selective serotonin reuptake inhibitor, other antidepressant, benzodiazepine, opioid, antiepileptic. Assessed by telephone interview of the participant

    Measured: Day 180 (+/-5) after enrollment

  24. Number of patients with fall(s) during hospitalization (hospitalization duration expected to be 3 to 20 days on average)

    Based on nurse report and electronic health record data

    Measured: Discharge (-1 to +2 days after discharge)

  25. Number of falls per patient during hospitalization (hospitalization duration expected to be 3 to 20 days on average)

    Based on nurse report and electronic health record data

    Measured: Discharge (-1 to +2 days after discharge)

  26. Number of patients with fall(s) within 30 days after discharge

    Assessed by telephone interview of the participant/relatives, based on a diary the participants/relatives will be asked to complete.

    Measured: Day 30 (+/-5) after enrollment

  27. Number of falls per patient within 30 days after discharge

    Assessed by telephone interview of the participant/relatives, based on a diary the participants/relatives will be asked to complete.

    Measured: Day 30 (+/-5) after enrollment

  28. Number of patients with fall(s) within 180 days after discharge

    Assessed by telephone interview of the participant/relatives, based on a diary the participants/relatives will be asked to complete.

    Measured: Day 180 (+/-5) after enrollment

  29. Number of falls per patient within 180 days after discharge

    Assessed by telephone interview of the participant/relatives, based on a diary the participants/relatives will be asked to complete.

    Measured: Day 180 (+/-5) after enrollment

  30. Number of patients with new institutionalization at discharge

    According to nurses / electronic health record / self-report by participant/relatives

    Measured: Discharge (-1 to +2 days after discharge)

  31. Number of patients with new institutionalization within 30 days of discharge

    Assessed by telephone interview of the participant/relatives

    Measured: Day 30 (+/-5) after enrollment

  32. Number of patients with new institutionalization within 180 days of discharge

    Assessed by telephone interview of the participant/relatives

    Measured: Day 180 (+/-5) after enrollment

  33. Number of patients with emergency room visits within 30 days of discharge

    Assessed based on electronic health record and by telephone interview of the participant/relatives, based on the diary the participant/relatives will be asked to complete.

    Measured: Day 30 (+/-5) after enrollment

  34. Number of emergency room visits per patient within 30 days of discharge

    Assessed based on electronic health record and by telephone interview of the participant/relatives, based on the diary the participant/relatives will be asked to complete.

    Measured: Day 30 (+/-5) after enrollment

  35. Number of patients with emergency room visits within 180 days of discharge

    Assessed based on electronic health record and by telephone interview of the participant/relatives, based on the diary the participant/relatives will be asked to complete.

    Measured: Day 180 (+/-5) after enrollment

  36. Number of emergency room visits per patient within 180 days of discharge

    Assessed based on electronic health record and by telephone interview of the participant/relatives, based on the diary the participant/relatives will be asked to complete.

    Measured: Day 180 (+/-5) after enrollment

  37. Number of patients with readmission within 30 days of discharge

    Assessed based on electronic health record and by telephone interview of the participant/relatives, based on the diary the participant/relatives will be asked to complete.

    Measured: Day 30 (+/-5) after enrollment

  38. Number of readmissions per patient within 30 days of discharge

    Assessed based on electronic health record and by telephone interview of the participant/relatives, based on the diary the participant/relatives will be asked to complete.

    Measured: Day 30 (+/-5) after enrollment

  39. Number of patients with readmission within 180 days of discharge

    Assessed based on electronic health record and by telephone interview of the participant/relatives, based on the diary the participant/relatives will be asked to complete.

    Measured: Day 180 (+/-5) after enrollment

  40. Number of readmissions per patient within 180 days of discharge

    Assessed based on electronic health record and by telephone interview of the participant/relatives, based on the diary the participant/relatives will be asked to complete.

    Measured: Day 180 (+/-5) after enrollment

  41. Experience of the intervention

    Assessed through qualitative and quantitative questions by interview of the participants/relatives (on the ward or by telephone). For the intervention group only. Will be done at the end of the assessment to preserve outcome assessor blinding.

    Measured: Discharge (-1 to +2 days after discharge)

  42. Satisfaction with hospitalization

    Measured by the satisfaction questionnaire adapted and simplified

    Measured: Discharge (-1 to +2 days after discharge)

  43. Perspectives on hospital mobility

    Quantitative questions (Likert-scale answers) based on the Health Action Process Approach (HAPA) model (simplification of a survey used in the preparation phase of this study to assess perspectives of patients and healthcare professionals on hospital mobility).

    Measured: Day 30 (+/-5) after enrollment

  44. Location at follow-up

    Assessed by telephone interview of patient/relatives.

    Measured: Day 30 (+/-5) after enrollment

  45. Location at follow-up

    Assessed by telephone interview of patient/relatives.

    Measured: Day 180 (+/-5) after enrollment

  46. Discharge destination

    Assessed based on electronic health records

    Measured: Discharge (-1 to +2 days after discharge)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2022
  2. Study start15 Dec 2022
  3. Primary completion18 Jul 2025
  4. Study completion18 Jul 2025

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
In a first phase, the intervention will be pilot-tested in one ward of each hospital (no comparison group). In a second phase, it will be tested in a parallel design (cluster randomized controlled trial).
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
383 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05639231
Sponsor's protocol ID
2022-01568
Acronym
INTOMOB
Status last verified
Aug 2025
First submitted
28 Nov 2022
Last updated
12 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study protocol, statistical analysis plan, informed consent form will be published. Other data will be made available upon reasonable request.

Publications

  • Mooser B, Bergsma D, Liechti FD, Baumgartner C, Gentizon J, Mean M, Wertli MM, Mancinetti M, Schmidt-Leuenberger J, Aubert CE. Impact of an INtervention to increase MOBility in older hospitalized medical patients (INTOMOB): Study protocol for a cluster randomized controlled trial. BMC Geriatr. 2023 Oct 31;23(1):705. doi: 10.1186/s12877-023-04285-3.

    PubMed 37907858

Questions about this trial

What is this clinical trial studying?

A study testing INTOMOB intervention in people with Hospital Mobility and Mobility Limitation, run by Insel Gruppe AG, University Hospital Bern at 4 sites in Switzerland.

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 7 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 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Switzerland. 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?

Life-space level (time frame: Day 30 (+/-5) after enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05639231, which also lists 1 linked publication.

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 12 Aug 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in