Goal-directed Mobilization of Medical Inpatients (GoMob-in)

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.

Study Overview

• Status: Completed
• Conditions: Delirium; Sarcopenia; Fall; Mobility Limitation; Hospital Acquired Condition; Immobility Syndrome
• Intervention / Treatment: Behavioral: Goal-directed mobilization

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fabian D Liechti, MD-PhD, Dr. med.; Phone Number: +41 (0)31 632 21 11; Email: fabian.liechti@insel.ch

Study Locations

• Switzerland
  • BE
    • Bern, BE, Switzerland, CH-3010
      • Inselspital, Bern University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard of care
Experimental: GDM; Goal-directed mobilization	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length-of-hospital-stay	Length-of-hospital-stay	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)	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)	3 months after study inclusion
Independence during activities of daily living: change in Barthel index between (German version)	By telephone interview with participant	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.	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.	3 months after study inclusion
Destination	Destination may include: death, acute care hospital, rehabilitation, home, nursing home, others	3 months after study inclusion
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	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")	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")	During hospitalization (max. 14±2 days)
Number of delirium episodes	As recorded in the discharge letter and nurse's protocol	During hospitalization (max. 14±2 days)
Number of in-hospital falls	As recorded in the nurse's protocol ("fall protocol")	During hospitalization (max. 14±2 days)
Reaching MCID	Reaching the minimal clinically important difference (MCID) of a change in DEMMI score (9 points) between baseline and discharge	Hospital discharge (max. day 14±2)

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Collaborators: University of Bern
• Investigators: Principal Investigator: Fabian D Liechti, MD-PhD, Dr. med., Inselspital, Bern University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2021
• Primary Completion (Actual): January 23, 2023
• Study Completion (Actual): April 18, 2023

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 15, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Disease Attributes; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia; Mobility Limitation; Iatrogenic Disease
• Other Study ID Numbers: GoMob-in

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study protocol, statistical analysis plan, informed consent form will be published. Other data will be made available upon reasonable request.
• IPD Sharing Time Frame: After study completion
• IPD Sharing Access Criteria: Upon reasonable request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No