Immobility SyndromeGoMob-inNCT04760392
Goal-directed Mobilization of Medical Inpatients
A study testing Goal-directed mobilization in people with Immobility Syndrome and Fall, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Immobilization in general internal medicine inpatients is a major contributor to morbidity and mortality. Goal-directed mobilization (GDM) may improve mobility. The aim of this study is to assess, if GDM increases physical activity (DEMMI score) during hospitalization and improves quality of care until 3 months after… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immobility Syndrome, Fall, Delirium
- What is being tested?
- Goal-directed mobilization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Sep 2021to 18 Apr 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
- All consenting patients aged ≥ 18 years admitted to the Department of General Internal Medicine, Inselspital, Bern University Hospital, Bern, Switzerland, who have an indication for physiotherapy (prescription by the resident in charge or the care coordinator).
- Participants must be randomized at latest on the second day after hospital admission.
- Written informed consent.
Who cannot join
- Inability to follow study procedures, i.e., due to language problems (unable to read, speak or understand German), psychological disorders, severe dementia (defined as to levels 5 - 7 in the Global Deterioration Scale), blindness, Patients unable to provide informed consent themselves
- Expected hospital stay for < 5 days
- Medically indicated bedrest for more than 24 h, e.g. after surgery
- Injuries or neurologic deficits of one or both lower extremities directly impairing walking capacity (e.g. fractures, hemiplegia, previous use of a wheelchair or bedriddenness)
- Terminal illness
- Pregnancy or breast feeding
- Previous enrolment in this study
- Enrolment of the investigator, his/her family members, employees and other dependent persons
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Inselspital, Bern University Hospital
Bern, Canton of Bern, CH-3010
About this study
Official title: Goal-directed Mobilization of Medical Inpatients (GoMob-in) - a Randomized, Controlled Trial
Immobilization in general internal medicine inpatients is a major contributor to morbidity and mortality. Goal-directed mobilization (GDM) may improve mobility. The aim of this study is to assess, if GDM increases physical activity (DEMMI score) during hospitalization and improves quality of care until 3 months after hospitalization.
- Conditions
- Immobility Syndrome, Fall, Delirium, Sarcopenia, Mobility Limitation, Hospital Acquired Condition
- Being tested
- Goal-directed mobilization
- Medical subject headings
- Delirium, Sarcopenia, Mobility Limitation, Iatrogenic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal-directed mobilizationBehavioural
- A short educational intervention with handout of a leaflet on GDM.
- Definition of personal mobility goal level.
- Communication of the mobility goal level to involved stakeholders.
- Regular reassessment of the mobility goal level and "booster sessions" by physiotherapists.
| Study group | Role | What they receive |
|---|---|---|
| GDM | Experimental | Goal-directed mobilization Receives: Behavioral: Goal-directed mobilization |
| Control | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of the DEMMI score
Change of the de Morton Mobility Index (DEMMI) score (range 0 to 100 with 0 indicating poor physical activity and 100 indicating a high level of independent physical activity) from baseline (at study inclusion), assessed by independent, blinded physiotherapist
Measured: Day 5±2
Secondary outcomes (13)
Change from baseline of the DEMMI score
Change of the de Morton Mobility Index (DEMMI) score (range 0 to 100 with 0 indicating poor physical activity and 100 indicating a high level of independent physical activity) from baseline (at study inclusion), assessed by independent, blinded physiotherapist
Measured: Hospital discharge (max. day 14±2)
Mobilization time
Mobilization time measured by accelerometer (i.e., time "moving" as total of time "inactive" and "static", excluding time "not worn")
Measured: Day 5±2
Mobilization time
Mobilization time measured by accelerometer (i.e., time "moving" as total of time "inactive" and "static", excluding time "not worn")
Measured: During hospitalization (max. 14±2 days)
Number of delirium episodes
As recorded in the discharge letter and nurse's protocol
Measured: During hospitalization (max. 14±2 days)
Number of in-hospital falls
As recorded in the nurse's protocol ("fall protocol")
Measured: During hospitalization (max. 14±2 days)
Length-of-hospital-stay
Length-of-hospital-stay
Measured: 3 months
Total number of falls (with / without injuries)
By telephone interview with participant (if not available the patients next of kin or family doctor)
Measured: 3 months after study inclusion
Number of re-hospitalizations and all-cause mortality
By telephone interview with participant (if not available the patients next of kin or family doctor)
Measured: 3 months after study inclusion
Independence during activities of daily living: change in Barthel index between (German version)
By telephone interview with participant
Measured: 3 months after study inclusion
Concerns of falling: change in Falls Efficacy Scale - International (FES-I, German version)
Change (range 16 to 64 with 16 indicating no fear of falling and 64 indicating a high level of fear of falling) from baseline (at study inclusion), assessed by telephone interview with participant.
Measured: 3 months after study inclusion
Quality of life: change in EuroQol (EQ-5D-5L, German version)
Change (range from 0 to 100 with 0 indicating no problem and indicating 100 extreme problems) from baseline (at study inclusion), assessed by telephone interview with participant.
Measured: 3 months after study inclusion
Destination
Destination may include: death, acute care hospital, rehabilitation, home, nursing home, others
Measured: 3 months after study inclusion
Reaching MCID
Reaching the minimal clinically important difference (MCID) of a change in DEMMI score (9 points) between baseline and discharge
Measured: Hospital discharge (max. day 14±2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start13 Sep 2021
- Primary completion23 Jan 2023
- Study completion18 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Immobility SyndromeStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Sponsor
- Investigators
- Fabian D Liechti, MD-PhD, Dr. med., Principal investigator, Inselspital, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760392
- Sponsor's protocol ID
- GoMob-in
- Acronym
- GoMob-in
- Status last verified
- Sep 2023
- First submitted
- 8 Feb 2021
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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
Liechti FD, Heinzmann J, Schmutz NA, Rossen ML, Rossel JB, Limacher A, Schmidt Leuenberger JM, Baumgartner C, Wertli MM, Aujesky D, Verra M, Aubert CE. Effect of goal-directed mobilisation versus standard care on physical functioning among medical inpatients: the GoMob-in randomised, controlled trial. BMJ Open. 2024 Nov 14;14(11):e086921. doi: 10.1136/bmjopen-2024-086921.
PubMed 39542489Liechti FD, Heinzmann J, Schmidt Leuenberger JM, Limacher A, Wertli MM, Verra ML. Effect of goal-directed mobilisation intervention compared with standard care on physical activity among medical inpatients: protocol for the GoMob-in randomised controlled trial. BMJ Open. 2022 May 12;12(5):e058509. doi: 10.1136/bmjopen-2021-058509.
PubMed 35551091
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal-directed Mobilization of Medical Inpatients (GoMob-in) - a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04760392
- Acronym / sponsor ID
- GoMob-in / GoMob-in
- Conditions
- Immobility Syndrome, Fall, Delirium, Sarcopenia, Mobility Limitation, Hospital Acquired Condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 23 Jan 2023 (actual)
- Study completion
- 18 Apr 2023 (actual)
- First posted
- 18 Feb 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.
Immobilization in general internal medicine inpatients is a major contributor to morbidity and mortality. Goal-directed mobilization (GDM) may improve mobility. The aim of this study is to assess, if GDM increases physical activity (DEMMI score) during hospitalization and improves quality of care until 3 months after hospitalization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GDM | Experimental | Behavioral: Goal-directed mobilizationGoal-directed mobilization |
| Control | No intervention | –Standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All consenting patients aged ≥ 18 years admitted to the Department of General Internal Medicine, Inselspital, Bern University Hospital, Bern, Switzerland, who have an indication for physiotherapy (prescription by the resident in charge or the care coordinator).
- Participants must be randomized at latest on the second day after hospital admission.
- Written informed consent.
Key exclusion criteria (8 listed)
- Inability to follow study procedures, i.e., due to language problems (unable to read, speak or understand German), psychological disorders, severe dementia (defined as to levels 5 - 7 in the Global Deterioration Scale), blindness, Patients unable to provide informed consent themselves
- Expected hospital stay for < 5 days
- Medically indicated bedrest for more than 24 h, e.g. after surgery
- Injuries or neurologic deficits of one or both lower extremities directly impairing walking capacity (e.g. fractures, hemiplegia, previous use of a wheelchair or bedriddenness)
- Terminal illness
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 |
|---|---|---|
| Goal-directed mobilization* A short educational intervention with handout of a leaflet on GDM. * Definition of personal mobility goal level. * Communication of the mobility goal level to involved stakeholders. * Regular reassessment of the mobility goal level and "booster sessions" by physiotherapists. | Behavioural | GDM |
Primary outcome
Change from baseline of the DEMMI score
Time frame: Day 5±2
Change of the de Morton Mobility Index (DEMMI) score (range 0 to 100 with 0 indicating poor physical activity and 100 indicating a high level of independent physical activity) from baseline (at study inclusion), assessed by independent, blinded physiotherapist
13 secondary outcomes
Change from baseline of the DEMMI score
Time frame: Hospital discharge (max. day 14±2)
Mobilization time
Time frame: Day 5±2
Mobilization time
Time frame: During hospitalization (max. 14±2 days)
Number of delirium episodes
Time frame: During hospitalization (max. 14±2 days)
Number of in-hospital falls
Time frame: During hospitalization (max. 14±2 days)
Length-of-hospital-stay
Time frame: 3 months
Total number of falls (with / without injuries)
Time frame: 3 months after study inclusion
Number of re-hospitalizations and all-cause mortality
Time frame: 3 months after study inclusion
Independence during activities of daily living: change in Barthel index between (German version)
Time frame: 3 months after study inclusion
Concerns of falling: change in Falls Efficacy Scale - International (FES-I, German version)
Time frame: 3 months after study inclusion
Quality of life: change in EuroQol (EQ-5D-5L, German version)
Time frame: 3 months after study inclusion
Destination
Time frame: 3 months after study inclusion
Reaching MCID
Time frame: Hospital discharge (max. day 14±2)
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 3 Oct 2023.
- Derived from this study: PubMed 39542489Liechti FD, Heinzmann J, Schmutz NA, Rossen ML, Rossel JB, Limacher A, Schmidt Leuenberger JM, Baumgartner C, Wertli MM, Aujesky D, Verra M, Aubert CE. Effect of goal-directed mobilisation versus standard care on physical functioning among medical inpatients: the GoMob-in randomised, controlled trial. BMJ Open. 2024 Nov 14;14(11):e086921. doi: 10.1136/bmjopen-2024-086921.
- Derived from this study: PubMed 35551091Liechti FD, Heinzmann J, Schmidt Leuenberger JM, Limacher A, Wertli MM, Verra ML. Effect of goal-directed mobilisation intervention compared with standard care on physical activity among medical inpatients: protocol for the GoMob-in randomised controlled trial. BMJ Open. 2022 May 12;12(5):e058509. doi: 10.1136/bmjopen-2021-058509.
- Individual participant dataSharing planned: Yes. Study protocol, statistical analysis plan, informed consent form will be published. Other data will be made available upon reasonable request.
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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.
Fabian D Liechti, MD-PhD, Dr. med. principal investigator
Inselspital, Bern University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal-directed mobilization in people with Immobility Syndrome and Fall, run by Insel Gruppe AG, University Hospital Bern at 1 site 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 3 inclusion and 8 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 3 Oct 2023. 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 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?
Change from baseline of the DEMMI score (time frame: Day 5±2). 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 NCT04760392, which also lists 2 linked publications.
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 3 Oct 2023.