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Completed

NCT Number: NCT04760392

Goal-directed Mobilization of Medical Inpatients

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.

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Key information

Conditions

Immobility Syndrome Atrophy Confusion Delirium Disease Attributes Fall Hospital Acquired Condition Iatrogenic Disease Mental Disorders Mobility Limitation Muscular Atrophy Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inselspital, Bern University Hospital

Bern, Canton of Bern, CH-3010, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Change from baseline of the DEMMI score

    Time frame: 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

  2. Mobilization time

    Time frame: Day 5±2

    Mobilization time measured by accelerometer (i.e., time "moving" as total of time "inactive" and "static", excluding time "not worn")

  3. Mobilization time

    Time frame: 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")

  4. Number of delirium episodes

    Time frame: During hospitalization (max. 14±2 days)

    As recorded in the discharge letter and nurse's protocol

  5. Number of in-hospital falls

    Time frame: During hospitalization (max. 14±2 days)

    As recorded in the nurse's protocol ("fall protocol")

  6. Length-of-hospital-stay

    Time frame: 3 months

    Length-of-hospital-stay

  7. Total number of falls (with / without injuries)

    Time frame: 3 months after study inclusion

    By telephone interview with participant (if not available the patients next of kin or family doctor)

  8. Number of re-hospitalizations and all-cause mortality

    Time frame: 3 months after study inclusion

    By telephone interview with participant (if not available the patients next of kin or family doctor)

  9. Independence during activities of daily living: change in Barthel index between (German version)

    Time frame: 3 months after study inclusion

    By telephone interview with participant

  10. Concerns of falling: change in Falls Efficacy Scale - International (FES-I, German version)

    Time frame: 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.

  11. Quality of life: change in EuroQol (EQ-5D-5L, German version)

    Time frame: 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.

  12. Destination

    Time frame: 3 months after study inclusion

    Destination may include: death, acute care hospital, rehabilitation, home, nursing home, others

  13. Reaching MCID

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • University of Bern

Registry information

Official study title

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

Acronym: GoMob-in

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 18, 2021
Registry last updated
Oct 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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