An interventional study of INTOMOB intervention in Hospital Mobility, Mobility Limitation and Life-Space, sponsored by Insel Gruppe AG, University Hospital Bern. Completed at 4 sites in Switzerland. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-08-12.
Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Prevention
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.
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:
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.
381 studies on the registry are indexed under Mobility Limitation; 108 are open to participants now.
This study's enrollment of 383 is above the median of 46 across 316 interventional studies indexed under Mobility Limitation.
Browse Mobility Limitation studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 741 studies on the registry; 180 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Additional exclusion criterion for the pilot-study only:
- Dementia (defined as Mini-Cog \<3)
Additional exclusion criteria for the RCT only:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The intervention will be multilevel, targeting the patients, healthcare professionals (HCPs) and environment, as described under "Intervention description".
Behavioral: INTOMOB intervention
Control 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.
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.
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.
Time frame: Day 30 (+/-5) after enrollment
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
Time frame: Day 180 (+/-5) after enrollment
Activities of Daily Living
Measured by the Barthel Index by telephone interview of the participant/relatives
Time frame: Day 30 (+/-5) after enrollment
Activities of Daily Living
Measured by the Barthel Index by telephone interview of the participant/relatives
Time frame: Day 180 (+/-5) after enrollment
Instrumental Activities of Daily Living
Measured by the Lawton Index by telephone interview of the participant/relatives
Time frame: Day 30 (+/-5) after enrollment
Instrumental Activities of Daily Living
Measured by the Lawton Index by telephone interview of the participant/relatives
Time frame: Day 180 (+/-5) after enrollment
Quality of life (EQ-5D)
Measured by the European Quality of Life-5 Dimensions (EQ-5D) questionnaire by telephone interview of the participant/relatives
Time frame: Day 30 (+/-5) after enrollment
Quality of life (EQ-5D)
Measured by the European Quality of Life-5 Dimensions (EQ-5D) questionnaire by telephone interview of the participant/relatives
Time frame: Day 180 (+/-5) after enrollment
Depression
Measured by the Patient Health Questionnaire (PHQ)-2 by telephone interview of the participant/relatives
Time frame: Day 30 (+/-5) after enrollment
Depression
Measured by the Patient Health Questionnaire (PHQ)-2 by telephone interview of the participant/relatives
Time frame: Day 180 (+/-5) after enrollment
Pressure ulcer
Evaluated according to the NPUAP/EPUAP classification, based on nurse report and electronic health record
Time frame: Discharge (-1 to +2 days after discharge)
Delirium during hospitalization (hospitalization duration expected to be 3 to 20 days on average)
Measured by the Confusion Assessment Method
Time frame: Discharge (-1 to +2 days after discharge)
Mobility at discharge
Measured by the de Morton Mobility Index (DEMMI); assessment conducted by the study team
Time frame: Discharge (maximum 1 day before)
Lower-limb muscle strength
Measured by lower-limb manual testing according to the method by Hislop and Montgomery; assessment conducted by the study team
Time frame: Discharge (maximum 1 day before)
Hand-grip muscle strength
Measured by JAMAR (for the pilot study) and SAEHAN (for the RCT) hand dynamometer; assessment conducted by the study team
Time frame: Discharge (maximum 1 day before)
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)
Time frame: Discharge (hospitalization duration expected to be 3 to 20 days on average)
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)
Time frame: Discharge (hospitalization duration expected to be 3 to 20 days on average)
Fear of / concerns about falling
Measured by the Falls Efficacy Scale - International by telephone interview of the participant/relatives
Time frame: Discharge (-1 to +2 days after discharge)
Fear of / concerns about falling
Measured by the Falls Efficacy Scale - International by telephone interview of the participant/relatives
Time frame: Day 30 (+/-5) after enrollment
Fear of / concerns about falling
Measured by the Falls Efficacy Scale - International by telephone interview of the participant/relatives
Time frame: Day 180 (+/-5) after enrollment
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
Time frame: Discharge (discharge letter) (hospitalization duration expected to be 3 to 20 days on average)
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
Time frame: Discharge (discharge letter) (hospitalization duration expected to be 3 to 20 days on average)]
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
Time frame: Day 30 (+/-5) after enrollment
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
Time frame: Day 180 (+/-5) after enrollment
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
Time frame: Discharge (-1 to +2 days after discharge)
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
Time frame: Discharge (-1 to +2 days after discharge)
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.
Time frame: Day 30 (+/-5) after enrollment
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.
Time frame: Day 30 (+/-5) after enrollment
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.
Time frame: Day 180 (+/-5) after enrollment
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.
Time frame: Day 180 (+/-5) after enrollment
Number of patients with new institutionalization at discharge
According to nurses / electronic health record / self-report by participant/relatives
Time frame: Discharge (-1 to +2 days after discharge)
Number of patients with new institutionalization within 30 days of discharge
Assessed by telephone interview of the participant/relatives
Time frame: Day 30 (+/-5) after enrollment
Number of patients with new institutionalization within 180 days of discharge
Assessed by telephone interview of the participant/relatives
Time frame: Day 180 (+/-5) after enrollment
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.
Time frame: Day 30 (+/-5) after enrollment
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.
Time frame: Day 30 (+/-5) after enrollment
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.
Time frame: Day 180 (+/-5) after enrollment
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.
Time frame: Day 180 (+/-5) after enrollment
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.
Time frame: Day 30 (+/-5) after enrollment
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.
Time frame: Day 30 (+/-5) after enrollment
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.
Time frame: Day 180 (+/-5) after enrollment
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.
Time frame: Day 180 (+/-5) after enrollment
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.
Time frame: Discharge (-1 to +2 days after discharge)
Satisfaction with hospitalization
Measured by the satisfaction questionnaire adapted and simplified
Time frame: Discharge (-1 to +2 days after discharge)
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).
Time frame: Day 30 (+/-5) after enrollment
Location at follow-up
Assessed by telephone interview of patient/relatives.
Time frame: Day 30 (+/-5) after enrollment
Location at follow-up
Assessed by telephone interview of patient/relatives.
Time frame: Day 180 (+/-5) after enrollment
Discharge destination
Assessed based on electronic health records
Time frame: Discharge (-1 to +2 days after discharge)
Healthcare professional experience of the intervention and perspectives on hospital mobility
Semi-structured interview and survey (in the intervention group only)
Time frame: After cluster closure (on average 1 to 10 months, maximum 15 months)
Patient opinion on comfort and practicability of the StepWatch and GENEActiv accelerometers
Outcome of the pilot study only. Assessment through semi-structured interview
Time frame: Discharge (-1 to +2 days after discharge)
Patient opinion on comfort and practicability of the ActiGraph accelerometer
Outcome of the randomized trial only. Assessment through semi-structured interview
Time frame: Discharge (-1 to +2 days after discharge)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Study protocol, statistical analysis plan, informed consent form will be published. Other data will be made available upon reasonable request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: After study completion
Access criteria: Upon reasonable request
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Insel Gruppe AG, University Hospital Bern →