ROBot Assisted Physical Training of Older Patients During acUte

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05782855
Study type	Interventional
Source	Odense University Hospital
Contact	Ann Sophia Bertelsen, PhD student
Phone	+4529631326
Email	ann.sophia.bertelsen@rsyd.dk
Status	Recruiting
Phase	N/A
Start date	January 5, 2023
Completion date	July 31, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

ROBot Assisted Physical Training of Older Patients During acUte hospitaliSaTion — ROBUST

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms