NCT05782855

ROBot Assisted Physical Training of Older Patients During acUte hospitaliSaTion

ROBot Assisted Physical Training of Older Patients During acUte hospitaliSaTion (ROBUST) - a Randomised Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 488 (estimated)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Functional Decline
• ADL
• Physical Inactivity
• Acute Illness

Interventions

Type	Name	Description
OTHER	Active Robot assisted physical training during acute hospitalisation	Active training is delivered by an innovative training robot (ROBERT®). The robot is handled by staff who attaches the robot to the patient's leg. The staff programs the exercise movement, whereby the robot remembers the movement. The robot holds the patient's leg and perform extension of hip and knee. The patient must use their muscular power to stretch the leg while ROBERT® provides resistance. Training is defined as a minimum of three sessions before discharge.
OTHER	Passive Robot assisted physical training during acute hospitalisation	Passive training is delivered by an innovative training robot (ROBERT®). The robot is handled by staff who attaches the robot to the patient's leg. The staff programs the movement, whereby the robot remembers the movement. The robot holds the patient's leg and perform passive extension of hip and knee. ROBERT® moves the leg independently without the patient using any muscle power. Training is defined as a minimum of three sessions before discharge.

Timeline

• Start date: 2023-01-05
• Primary completion: 2024-12-20
• Completion: 2026-07-31
• First posted: 2023-03-24
• Last updated: 2025-09-08

Locations

1 site across 1 country: Denmark