Impact of Acute Hospitalisation and Resistance Training on Muscle Architecture and Physical Performance in Older Adults

Sarcopenia characterised by loss of muscle mass, muscle strength and physical performance burdens many older adults since the condition is related to functional decline. Periods of inactivity such as during hospitalisation leads to further functional decline. It has been reported that the loss of muscle mass associated with sarcopenia not only entails a decrease in muscle mass but also changes in muscle architecture. Knowledge on changes in muscle architecture is essential since it is one of the most important determinants on muscle strength and thus physical performance. The main objective of this study is to investigate changes in muscle architecture and physical performance during acute hospitalisation and after discharge in older adults and subsequently the effectiveness of resistance training of the lower limb during acute hospitalisation. If successful, our study could have a great impact on the individual, as well as societal level, due to a better understanding of the factors related to sarcopenia and the prevention of functional decline as a result of hospitalisation.

Study Overview

• Status: Completed
• Conditions: Sarcopenia; Older Adults; Ultrasound; Resistance Training; Acutely Ill; Physical Performance; Muscle Architecture; Hospitalisation; Functional Decline; Gait Speed
• Intervention / Treatment: Other: Resistance training

• Study Type: Interventional
• Enrollment (Actual): 274
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • FYN
    • Svendborg, FYN, Denmark, 5700
      • Geriatric Deparment OUH Svendborg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• ≥65 years of age
• Able to ambulate before hospitalization (with/without assistance)
• Able to communicate with the research team
• Expected length of stay ≥2 days
• Residing on Funen

Exclusion Criteria:

• Able to ambulate without assistance during current hospitalization
• Known severe dementia
• Positive Confusion and Assessment Method score
• Patients who have received less than 3 resistance 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 hip
• Deemed not suitable for resistance training sessions with the robot by the healthcare professional.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Group of participants receiving resistance training during hospitalisation	Other: Resistance training; Moderate resistance training by a innovative training robot 2 times a day during hospitalisation
Sham Comparator: Control Group; Group of participants receiving sham training during hospitalisation	Other: Resistance training; Moderate resistance training by a innovative training robot 2 times a day during hospitalisation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline B-mode ultrasonography	Muscle architecture of the m Vastus Lateralis assessed with B-mode ultrasonography.	Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week).
Change from baseline 4 meter Gait Speed Test	Physical performance evaluated by the 4m Gait Speed test	Baseline (Day of hospitalisation) to day of discharge from hospital (an average of a week).
Change from baseline B-mode ultrasonography	Muscle architecture of the muscle vastus lateralis assessed with B-mode ultrasonography.	Change from baseline (day of hospitalisation) to 1-month follow-up and 3-months follow-up
Change from baseline 4 meter Gait Speed Test	Physical performance evaluated by the 4m Gait Speed test	Change from baseline (day of hospitalisation) to 1-month follow-up and 3-months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline 30s Chair Stand test	Maximal muscle strength of the lower extremities evaluated by the 30s Chair Stand Test or the m30s Chair Stand Test (Modified).	Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week)
Change from baseline Barthel-Index 100 (Shahs version)	Functional level evaluated by The Barthel-Index 100 (Shahs version)	Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week)
Change from baseline Bioimpedance	Muscle quantity (kg) on wholebody level evaluated by Bioimpedance	Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week)
Length of hospital stay	Number of days hospitalised	Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week)
Mortality	Administrative registers will be used to assess mortality	Baseline (day of hospitalization) to 3-months follow-up
Unplanned hospitalisation	Patients will be followed through a review of medical records for any unplanned Adminstrative registers will be used to assess any unplanned hospitalisation during the period of inclusion.	Day of discharge from hospital to 3-months follow-up
Individual level of physiotherapy	Adminstrative registers and municipalities health records will be used to assess the individual level of physiotherapy (minutes of consultation) in the period of inclusion.	Baseline (day of hospitalisation) to 3-months follow-up

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: University of Copenhagen; Nottingham University Hospitals NHS Trust
• Investigators: Study Director: Kristian B Buhl, MD, Department of Geriatric, Odense University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2023
• Primary Completion (Actual): December 20, 2024
• Study Completion (Actual): December 20, 2024

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: March 22, 2023
• First Posted (Actual): April 4, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: ARTMAP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No