Clinical trial NCT04760392: Goal-directed Mobilization of Medical Inpatients
Official title: Goal-directed Mobilization of Medical Inpatients (GoMob-in) - a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immobility Syndrome
Fall
Delirium
Sarcopenia
Mobility Limitation
Hospital Acquired Condition
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University of Bern
First posted: 2021-02-18
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 hospitalization.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from baseline of the DEMMI score
timeFrame: Day 5±2
Secondary outcomes:
measure: Change from baseline of the DEMMI score
timeFrame: Hospital discharge (max. day 14±2)
measure: Mobilization time
timeFrame: Day 5±2
measure: Mobilization time
timeFrame: During hospitalization (max. 14±2 days)
measure: Number of delirium episodes
timeFrame: During hospitalization (max. 14±2 days)
measure: Number of in-hospital falls
timeFrame: During hospitalization (max. 14±2 days)
measure: Length-of-hospital-stay
timeFrame: 3 months
measure: Total number of falls (with / without injuries)
timeFrame: 3 months after study inclusion
measure: Number of re-hospitalizations and all-cause mortality
timeFrame: 3 months after study inclusion
measure: Independence during activities of daily living: change in Barthel index between (German version)
timeFrame: 3 months after study inclusion
measure: Concerns of falling: change in Falls Efficacy Scale - International (FES-I, German version)
timeFrame: 3 months after study inclusion
measure: Quality of life: change in EuroQol (EQ-5D-5L, German version)
timeFrame: 3 months after study inclusion
measure: Destination
timeFrame: 3 months after study inclusion
measure: Reaching MCID
timeFrame: Hospital discharge (max. day 14±2)
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital, Bern University Hospital
state: BE
Study officials:
affiliation: Inselspital, Bern University Hospital
name: Fabian D Liechti, MD-PhD, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liechti 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.