ROBot Assisted Physical Training of Older Patients During acUte hospitaliSaTion (ROBUST)

Odense University Hospital

Status: Active, not recruiting

Conditions: Physical Inactivity; ADL; Functional Decline; Acute Illness

Treatments: Other: Active Robot assisted physical training during acute hospitalisation; Other: Passive Robot assisted physical training during acute hospitalisation

Study type: Interventional

Funder types: Other

Identifiers

NCT05782855

ROBUST

Details and patient eligibility

About

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.

Full 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.

Enrollment: 488 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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488 participants in 2 patient groups

Control group

Sham Comparator group

Description:

Participants in the control group will receive usual individualized training with a physiotherapist and passive sham training of lower extremities with the rehabilitation robot twice a day until day of discharge. The physiotherapist will be blinded to allocation. Sham training consists of 3 sets of 8 passive repetitions with each leg twice a day.

Treatment:

Other: Passive Robot assisted physical training during acute hospitalisation

Intervention group

Active Comparator group

Description:

The intervention group will receive usual individualized training with a physiotherapist and active strength training of lower extremities by the robot twice a day until day of discharge. The physiotherapist will be blinded to allocation. Training will focus on the muscle groups in the lower extremities, which are used to get up from a chair and walk around (thigh- and calf muscles). Active training consists of 3 sets of maximum repetitions with a minimum of 65% (65-80%) intensity of 1 RM with each leg twice a day.

Treatment:

Other: Active Robot assisted physical training during acute hospitalisation