Goal-directed Mobilization of Medical Inpatients

Sarcopenia Clinical Trial

— GoMob-in  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04760392
• Other study ID #: GoMob-in
• Status: Completed
• Phase: N/A
• Start date: September 13, 2021
• Est. completion date: April 18, 2023

Study information

• Verified date: September 2023
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: April 18, 2023
• Est. primary completion date: January 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Fall
• Hospital Acquired Condition
• Iatrogenic Disease
• Immobility Syndrome
• Mobility Limitation
• Sarcopenia

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Inselspital, Bern University Hospital	Bern	BE

Sponsors (2)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern	University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
Secondary	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)
Secondary	Number of delirium episodes	As recorded in the discharge letter and nurse's protocol	During hospitalization (max. 14±2 days)
Secondary	Number of in-hospital falls	As recorded in the nurse's protocol ("fall protocol")	During hospitalization (max. 14±2 days)
Secondary	Length-of-hospital-stay	Length-of-hospital-stay	3 months
Secondary	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
Secondary	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
Secondary	Independence during activities of daily living: change in Barthel index between (German version)	By telephone interview with participant	3 months after study inclusion
Secondary	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
Secondary	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
Secondary	Destination	Destination may include: death, acute care hospital, rehabilitation, home, nursing home, others	3 months after study inclusion
Secondary	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)