Goal-directed Mobilization of Medical Inpatients

Not Applicable

Completed

• Conditions: Fall; Sarcopenia; Immobility Syndrome; Mobility Limitation; Delirium; Hospital Acquired Condition
• Interventions: Behavioral: Goal-directed mobilization

• Registration Number: NCT04760392
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-15
• Study First Posted: 2021-02-18
• Study Start: 2021-09-13
• Primary Completion: 2023-01-23
• Study Completion: 2023-04-18
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-28
• Last Update Posted: 2023-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GDM	Goal-directed mobilization	Goal-directed mobilization

Primary Outcome Measures

Name	Time	Method
Change from baseline of the DEMMI score	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 Outcome Measures

Name	Time	Method
Destination	3 months after study inclusion	Destination may include: death, acute care hospital, rehabilitation, home, nursing home, others
Length-of-hospital-stay	3 months	Length-of-hospital-stay
Number of delirium episodes	During hospitalization (max. 14±2 days)	As recorded in the discharge letter and nurse's protocol
Total number of falls (with / without injuries)	3 months after study inclusion	By telephone interview with participant (if not available the patients next of kin or family doctor)
Number of in-hospital falls	During hospitalization (max. 14±2 days)	As recorded in the nurse's protocol ("fall protocol")
Independence during activities of daily living: change in Barthel index between (German version)	3 months after study inclusion	By telephone interview with participant
Change from baseline of the DEMMI score	Hospital discharge (max. day 14±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
Mobilization time	During hospitalization (max. 14±2 days)	Mobilization time measured by accelerometer (i.e., time "moving" as total of time "inactive" and "static", excluding time "not worn")
Reaching MCID	Hospital discharge (max. day 14±2)	Reaching the minimal clinically important difference (MCID) of a change in DEMMI score (9 points) between baseline and discharge
Number of re-hospitalizations and all-cause mortality	3 months after study inclusion	By telephone interview with participant (if not available the patients next of kin or family doctor)
Concerns of falling: change in Falls Efficacy Scale - International (FES-I, German version)	3 months after study inclusion	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.
Quality of life: change in EuroQol (EQ-5D-5L, German version)	3 months after study inclusion	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.

Trial Locations

Locations (1)

Inselspital, Bern University Hospital; 🇨🇭 Bern, BE, Switzerland