Clinical trial NCT05782855: ROBot Assisted Physical Training of Older Patients During acUte hospitaliSaTion
Official title: ROBot Assisted Physical Training of Older Patients During acUte hospitaliSaTion (ROBUST) - a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Functional Decline
ADL
Physical Inactivity
Acute Illness
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 488
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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 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 lower extremity fractures; high intracranial pressure; pressure ulcers or risk of developing pressure 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 healthcare professional
* If the patient weighs more than 165 kg (the robot cannot lift the leg if the patient is severely overweight)

Primary outcomes:
measure: Change from baseline Barthel Index 100
timeFrame: Change from baseline (day of hospital admission) to day of hospital discharge (an average of 1 week)
measure: Change from baseline 30 Second Sit to Stand Test
timeFrame: Change from baseline (day of hospital admission) to day of hospital discharge (an average of 1 week)
Secondary outcomes:
measure: Quality of life EQ-5D
timeFrame: Day of hospital admission; day of hospital discharge (an average of 1 week); 1 month follow-up; 3 months follow-up.
measure: Mood status
timeFrame: Day of hospital admission; day of hospital discharge (an average of 1 week); 1 month follow-up; 3 months follow-up.
measure: Concern about falling including number of falls
timeFrame: Day of hospital admission; day of hospital discharge (an average of 1 week); 1 month follow-up; 3 months follow-up.
measure: Patient perspective by qualitative interviews
timeFrame: Day of hospital discharge (an average of 1 week); 1 month follow-up.
measure: Cognitive function
timeFrame: Day of hospital admission; day of hospital discharge (an average of 1 week); 1 month follow-up; 3 months follow-up.
measure: Muscle quantity
timeFrame: Day of hospital admission; day of hospital discharge (an average of 1 week); 1 month follow-up; 3 months follow-up.
measure: Sarcopenia
timeFrame: Day of hospital admission; day of hospital discharge (an average of 1 week); 1 month follow-up; 3 months follow-up.
measure: Need of care at home
timeFrame: From 3 months prior to day of hospital admission to 3 months following day of hospital discharge.
measure: Length of hospital stay
timeFrame: From day of hospital admission to day of hospital discharge (an average of 1 week).
measure: Discharge destination
timeFrame: Day of hospital discharge (an average of 1 week).
measure: Rate of hospital readmission
timeFrame: 30 days following day of hospital discharge.
measure: Health care cost evaluation
timeFrame: 3 months follow-up.
measure: Mortality
timeFrame: 1- and 3-months follow-up.
measure: Change from baseline Barthel Index 100
timeFrame: Change from baseline (day of hospital admission) to 1 month follow-up and 3 months follow-up.
measure: Change from baseline 30 Second Sit to Stand Test
timeFrame: Change from baseline (day of hospital admission) to 1 month follow-up and 3 months follow-up.
measure: Clinical Frailty Scale
timeFrame: Change from baseline (day of hospital admission) to 1 month follow-up and 3 months follow-up.
Other outcomes:
Locations:
city: Svendborg
country: Denmark
facility: Odense University Hospital/Svendborg Hospital
Study officials:
affiliation: Department of geriatric medicine Odense University hospital, Denmark
name: Jesper Ryg, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bertelsen AS, Storm A, Minet L, Ryg J. Use of robot technology in passive mobilization of acute hospitalized geriatric medicine patients: a pilot test and feasibility study. Pilot Feasibility Stud. 2020 Jan 6;6:1. doi: 10.1186/s40814-019-0545-z. eCollection 2020.