Impact of an INtervention TO Increase MOBility in Older Hospitalized Medical Patients (INTOMOB): a Cluster Randomized Controlled Trial
Trial tests a new program to boost mobility in older hospitalized patients.
Plain English Summary
An INtervention TO Improve MOBility of Older Hospitalized Patients is a Not Applicable clinical trial sponsored by Insel Gruppe AG, University Hospital Bern studying Hospital Mobility, Mobility Limitation, Life-Space, Functional Status, Hospital-Acquired Condition, Muscle Atrophy or Weakness, Sarcopenia, Iatrogenic Disease. This trial tests a program designed to help older patients who are hospitalized increase their physical activity and mobility. It is for individuals aged 60 and older who were able to walk before being admitted to the hospital and are living in the community. Participants will receive educational materials, a diary, exercise guides, and an iPad with exercise videos. Healthcare staff will also receive training and tools to encourage patient mobility. The alternative is standard hospital care, which may not actively focus on increasing patient mobility during their stay. The trial aims to enroll 383 participants.
Official 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. 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: 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are 60 or older, admitted to a general internal medicine ward, and could walk for two weeks before coming to the hospital. You must be living in the community (not a nursing home) and able to understand French or German. You cannot join if you have a medical reason preventing you from walking, are wheelchair-bound, are at the end of life, have severe psychiatric issues, or are experiencing delirium. Individuals with severe cognitive or visual impairment may also be excluded unless a caregiver can assist. This trial is studying Hospital Mobility, Mobility Limitation, Life-Space, Functional Status, Hospital-Acquired Condition, Muscle Atrophy or Weakness, Sarcopenia, Iatrogenic Disease, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures how far patients can move around in their daily lives (life-space mobility) 30 days after joining the study, indicating the intervention's success in improving their abili The specific primary outcome measures are: Life-space level (Day 30 (+/-5) after enrollment). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial addresses the common problem of reduced mobility in older hospitalized patients, which can lead to long-term functional decline, and aims to provide a practical solution. This research targets Hospital Mobility, Mobility Limitation, Life-Space, Functional Status, Hospital-Acquired Condition, Muscle Atrophy or Weakness, Sarcopenia, Iatrogenic Disease, where improved treatment options are needed.
Investor Insight
This trial focuses on a significant unmet need in geriatric care, with potential for broad application in hospitals to reduce complications and improve patient outcomes, suggesting a positive market s
Is This Trial Right for Me?
Ask your doctor about the specific exercises and how often you should be moving each day. You will be given materials to help you track your progress and encouraged to use an iPad for exercise videos. Daily activities might involve simple exercises and aiming to walk more, supported by hospital staff. The trial is being conducted at 4 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: TRIPLE
- Enrollment: 383 participants
Interventions
- BEHAVIORAL: INTOMOB intervention — 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 (ph
Primary Outcomes
- Life-space level (Day 30 (+/-5) after enrollment)
Secondary Outcomes
- Life-space level (Day 180 (+/-5) after enrollment)
- Activities of Daily Living (Day 30 (+/-5) after enrollment)
- Activities of Daily Living (Day 180 (+/-5) after enrollment)
- Instrumental Activities of Daily Living (Day 30 (+/-5) after enrollment)
- Instrumental Activities of Daily Living (Day 180 (+/-5) after enrollment)
Full Eligibility Criteria
Inclusion criteria: * 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 Exclusion criteria: * 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: \- 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
- Kantonsspital Baden, Baden, Canton of Aargau, Switzerland
- HFR-Fribourg - hôpital cantonal, Villars-sur-Glâne, Canton of Fribourg, Switzerland
- Spital Tiefenau, InselGruppe AG, Bern, Switzerland
- Inselspital, Bern University Hospital, InselGruppe AG, Bern, Switzerland
Frequently Asked Questions
What is clinical trial NCT05639231?
NCT05639231 is a Not Applicable INTERVENTIONAL study titled "An INtervention TO Improve MOBility of Older Hospitalized Patients." It is currently completed and is sponsored by Insel Gruppe AG, University Hospital Bern. The trial targets enrollment of 383 participants.
What conditions does NCT05639231 study?
This trial investigates treatments for Hospital Mobility, Mobility Limitation, Life-Space, Functional Status, Hospital-Acquired Condition, Muscle Atrophy or Weakness, Sarcopenia, Iatrogenic Disease. The primary condition under study is Hospital Mobility.
What treatments are being tested in NCT05639231?
The interventions being studied include: INTOMOB intervention (BEHAVIORAL). 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 (ph
What does Not Applicable mean for NCT05639231?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT05639231?
This trial is currently "Completed." It started on 2022-12-15. The estimated completion date is 2025-07-18.
Who is sponsoring NCT05639231?
NCT05639231 is sponsored by Insel Gruppe AG, University Hospital Bern. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05639231?
The trial aims to enroll 383 participants. The trial status is completed.
How is NCT05639231 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs triple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT05639231?
The primary outcome measures are: Life-space level (Day 30 (+/-5) after enrollment). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05639231 being conducted?
This trial is being conducted at 4 sites, including Baden, Canton of Aargau; Villars-sur-Glâne, Canton of Fribourg; Bern (Switzerland).
Where can I find official information about NCT05639231?
The official record for NCT05639231 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05639231. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05639231 testing in simple terms?
This trial tests a program designed to help older patients who are hospitalized increase their physical activity and mobility. It is for individuals aged 60 and older who were able to walk before being admitted to the hospital and are living in the community.
Why is this trial significant?
This trial addresses the common problem of reduced mobility in older hospitalized patients, which can lead to long-term functional decline, and aims to provide a practical solution.
What are the potential risks of participating in NCT05639231?
Potential risks include muscle strain or falls during exercise, especially if not performed correctly. Some patients might experience fatigue or discomfort from increased physical activity. There is a small risk of skin irritation from the iPad or other study materials. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05639231?
Ask your doctor about the specific exercises and how often you should be moving each day. You will be given materials to help you track your progress and encouraged to use an iPad for exercise videos. Daily activities might involve simple exercises and aiming to walk more, supported by hospital staff. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05639231 signal from an investment perspective?
This trial focuses on a significant unmet need in geriatric care, with potential for broad application in hospitals to reduce complications and improve patient outcomes, suggesting a positive market s This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will receive educational materials, a diary, exercise guides, and an iPad with exercise videos. Healthcare staff will also receive training and tools to encourage patient mobility. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.