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

NCT ID: NCT05798169

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 274 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-05
• Study Completion Date: 2024-12-20

Brief Summary

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.

Conditions

Sarcopenia; Functional Decline; Muscle Architecture; Gait Speed; Ultrasound; Physical Performance; Resistance Training; Hospitalisation; Acutely Ill; Older Adults

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention Group

Group of participants receiving resistance training during hospitalisation

Group Type: EXPERIMENTAL

Resistance training

Intervention Type: OTHER

Moderate resistance training by a innovative training robot 2 times a day during hospitalisation

Control Group

Group of participants receiving sham training during hospitalisation

Group Type: SHAM_COMPARATOR

Resistance training

Intervention Type: OTHER

Moderate resistance training by a innovative training robot 2 times a day during hospitalisation

Interventions

Resistance training

Moderate resistance training by a innovative training robot 2 times a day during hospitalisation

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Copenhagen

OTHER

Sponsor Role: collaborator

Nottingham University Hospitals NHS Trust

OTHER

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lisbeth Rosenbek Minet

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristian B Buhl, MD

Role: STUDY_DIRECTOR

Department of Geriatric, Odense University Hospital

Locations

Geriatric Deparment OUH Svendborg Hospital

Svendborg, FYN, Denmark

Countries

Denmark

Other Identifiers

ARTMAP

Identifier Type: -

Identifier Source: org_study_id