Goal-directed Mobilization of Medical Inpatients (GoMob-in) - a Randomized, Controlled Trial

Insel Gruppe AG, University Hospital Bern1 site in 1 country160 target enrollmentSeptember 13, 2021

ConditionsImmobility Syndrome Fall Delirium Sarcopenia Mobility Limitation Hospital Acquired Condition

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Immobility Syndrome
Sponsor: Insel Gruppe AG, University Hospital Bern
Enrollment: 160
Locations: 1
Primary Endpoint: Change from baseline of the DEMMI score
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 13, 2021

End Date

April 18, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Insel Gruppe AG, University Hospital Bern

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

Length-of-hospital-stay(3 months)
Number of delirium episodes(During hospitalization (max. 14±2 days))
Total number of falls (with / without injuries)(3 months after study inclusion)
Destination(3 months after study inclusion)
Number of in-hospital falls(During hospitalization (max. 14±2 days))
Independence during activities of daily living: change in Barthel index between (German version)(3 months after study inclusion)
Change from baseline of the DEMMI score(Hospital discharge (max. day 14±2))
Mobilization time(During hospitalization (max. 14±2 days))
Reaching MCID(Hospital discharge (max. day 14±2))
Number of re-hospitalizations and all-cause mortality(3 months after study inclusion)
Concerns of falling: change in Falls Efficacy Scale - International (FES-I, German version)(3 months after study inclusion)
Quality of life: change in EuroQol (EQ-5D-5L, German version)(3 months after study inclusion)