Goal-directed Mobilization of Medical Inpatients

NCT04760392 | Completed DMC

• 1 other identifier: GoMob-in
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Immobility Syndrome; Fall; Delirium; Sarcopenia; Mobility Limitation; Hospital Acquired Condition

Outcome Measures

Primary Outcomes (1)

• 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

  Day 5±2

Secondary Outcomes (13)

• Change from baseline of the DEMMI score

  Hospital discharge (max. day 14±2)

• Mobilization time

  Day 5±2

• Mobilization time

  During hospitalization (max. 14±2 days)

• Number of delirium episodes

  During hospitalization (max. 14±2 days)

• Number of in-hospital falls

  During hospitalization (max. 14±2 days)

Study Arms (2)

GDM

EXPERIMENTAL

Goal-directed mobilization

Behavioral: Goal-directed mobilization

Control

NO INTERVENTION

Standard of care

Interventions

Goal-directed mobilization BEHAVIORAL

* 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.

GDM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Bern: collaborator

Study Sites (1)

Inselspital, Bern University Hospital

Bern, Canton of Bern, CH-3010, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 39542489 DERIVED

• 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.

  PMID: 35551091 DERIVED

MeSH Terms

Conditions

Delirium; Sarcopenia; Mobility Limitation; Iatrogenic Disease

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Muscular Atrophy; Neuromuscular Manifestations; Atrophy; Pathological Conditions, Anatomical; Disease Attributes; Pathologic Processes

Study Officials

• Fabian D Liechti, MD-PhD, Dr. med.

  Inselspital, Bern University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 18, 2021
• Study Start: September 13, 2021
• Primary Completion: January 23, 2023
• Study Completion: April 18, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After study completion
• Access Criteria: Upon reasonable request

Locations

CH (1)