ROBot Assisted Physical Training of Older Patients During acUte hospitaliSaTion

NCT05782855 | Active Not Recruiting

• 1 other identifier: ROBUST
• Study Type: interventional
• Target: 488
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Decline; ADL; Physical Inactivity; Acute Illness

Outcome Measures

Primary Outcomes (2)

• Change from baseline Barthel Index 100

  Functional evaluation assessed by Barthel Index 100. The Barthel Index is an ordinal scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently following hospital discharge.

  Change from baseline (day of hospital admission) to day of hospital discharge (an average of 1 week)

• Change from baseline 30 Second Sit to Stand Test

  Functional evaluation assessed by 30 Second Sit to Stand Test . The 30 Second Sit to Stand Test is for testing leg strength and endurance in older adults.

  Change from baseline (day of hospital admission) to day of hospital discharge (an average of 1 week)

Secondary Outcomes (16)

• Quality of life EQ-5D

  Day of hospital admission; day of hospital discharge (an average of 1 week); 1 month follow-up; 3 months follow-up.

• Mood status

  Day of hospital admission; day of hospital discharge (an average of 1 week); 1 month follow-up; 3 months follow-up.

• Concern about falling including number of falls

  Day of hospital admission; day of hospital discharge (an average of 1 week); 1 month follow-up; 3 months follow-up.

• Patient perspective by qualitative interviews

  Day of hospital discharge (an average of 1 week); 1 month follow-up.

• Cognitive function

  Day of hospital admission; day of hospital discharge (an average of 1 week); 1 month follow-up; 3 months follow-up.

Study Arms (2)

Control group

SHAM COMPARATOR

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.

Other: Passive Robot assisted physical training during acute hospitalisation

Intervention group

ACTIVE COMPARATOR

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.

Other: Active Robot assisted physical training during acute hospitalisation

Interventions

Active Robot assisted physical training during acute hospitalisation OTHER

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.

Intervention group

Passive Robot assisted physical training during acute hospitalisation OTHER

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.

Control group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital/Svendborg Hospital

Svendborg, 5700, Denmark

Location

Related Publications (2)

• 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.

  PMID: 31921434 BACKGROUND

• Bertelsen AS, Masud T, Suetta C, Rosenbek Minet L, Andersen S, Lauridsen JT, Ryg J. ROBot-assisted physical training of older patients during acUte hospitaliSaTion-study protocol for a randomised controlled trial (ROBUST). Trials. 2024 Apr 4;25(1):235. doi: 10.1186/s13063-024-08044-6.

  PMID: 38576046 DERIVED

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Jesper Ryg, Professor

  Department of geriatric medicine Odense University hospital, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Consultant, MD

Study Record Dates

• First Submitted: December 27, 2022
• First Posted: March 24, 2023
• Study Start: January 5, 2023
• Primary Completion: December 20, 2024
• Study Completion (Estimated): July 31, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)