ROBot Assisted Physical Training of Older Patients During acUte hospitaliSaTion

Last updated: December 5, 2023
Sponsor: Odense University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Passive Robot assisted physical training during acute hospitalisation

Active Robot assisted physical training during acute hospitalisation

Clinical Study ID

NCT05782855
ROBUST
  • Ages > 65
  • All Genders

Study Summary

This study aims to address if robot assisted physical training can prevent functional decline during acute hospitalisation in older geriatric patients.

Design: blinded RCT. Patients: n = 488. Primary outcome is functional decline, assessed by Barthel-Index and 30s chair stand test. One- and three months follow-up.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≥65 years of age
  • Able to ambulate before hospitalisation (with/without assistance)
  • Able to communicate with the research team
  • Expected length of stay ≥2 days
  • Residing on Funen, Denmark

Exclusion

Exclusion Criteria:

  • Able to ambulate without assistance during current hospitalisation
  • Known severe dementia
  • Positive Confusion and Assessment Method score (20)
  • Patients who have received less than 3 training sessions at discharge
  • Terminal illness
  • Recent major surgery or lower extremity bone fracture in the last 3 months
  • Conditions contradicting use of ROBERT (unstable vertebral-, pelvic, or lowerextremity fractures; high intracranial pressure; pressure ulcers or risk of developingpressure ulcers due to fragile skin; patients with medical instability)
  • Metastases at femur or hip
  • Deemed not suitable for mobilization sessions with the robot by the healthcareprofessional
  • If the patient weighs more than 165 kg (the robot cannot lift the leg if the patientis severely overweight)

Study Design

Total Participants: 488
Treatment Group(s): 2
Primary Treatment: Passive Robot assisted physical training during acute hospitalisation
Phase:
Study Start date:
January 05, 2023
Estimated Completion Date:
July 31, 2025

Study Description

Introduction:

Inactivity during hospitalisation is associated with significant risk of functional decline especially in older patients. This have major impact on the individual level due to decreased wellbeing and higher level of dependency and on the society level due to increased caregiver burden following hospital discharge. This study aims to address if robot assisted physical training can prevent functional decline during acute hospitalisation in older geriatric patients.

Methods:

ROBUST is a blinded RCT. Patients (n = 488) admitted with acute medical illness to Department of Geriatric Medicine, Odense University Hospital will be randomised to usual care and robot assisted active strength training of lower extremities twice daily (intervention group) or usual care and robot assisted passive sham training (control group) until discharge. Both groups will receive protein supplements.

Inclusion criteria: ≥65 years of age, able to ambulate before hospitalisation, expected length of stay ≥2 days.

Exclusion criteria: Able to ambulate without assistance during current hospitalisation, severe dementia, delirium, conditions contradicting robot training.

The primary outcome, functional decline, will be assessed by Barthel-Index and 30s chair stand test.

Secondary outcomes include Quality of life (EQ-5D), Geriatric Depression Scale, Fear of falling (FES-I), cognition (MMSE), qualitative interviews, falls, caregiver burden, discharge destination, readmissions, healthcare costs, sarcopenia, and mortality.

Outcomes will be assessed at admission, discharge, and one- and three months follow-up. Data on comorbidity, medications, blood samples, and clinical frailty scale will be collected.

Discussion: This study will investigate the effects of in-hospital robot assisted strength training on functional status in older patients with multimorbidity.

Connect with a study center

  • Odense University Hospital/Svendborg Hospital

    Svendborg, 5700
    Denmark

    Active - Recruiting

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