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

NCT05798169 | Completed

• 1 other identifier: ARTMAP
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Change from baseline 30s Chair Stand test

  Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week)

• Change from baseline Barthel-Index 100 (Shahs version)

  Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week)

• Change from baseline Bioimpedance

  Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week)

• Length of hospital stay

  Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week)

• Mortality

  Baseline (day of hospitalization) to 3-months follow-up

Study Arms (2)

Intervention Group

EXPERIMENTAL

Group of participants receiving resistance training during hospitalisation

Other: Resistance training

Control Group

SHAM COMPARATOR

Group of participants receiving sham training during hospitalisation

Other: Resistance training

Interventions

Resistance training OTHER

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

Control Group; Intervention Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Odense University Hospital: lead
• University of Copenhagen: collaborator
• Nottingham University Hospitals NHS Trust: collaborator

Study Sites (1)

Geriatric Deparment OUH Svendborg Hospital

Svendborg, FYN, 5700, Denmark

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kristian B Buhl, MD

  Department of Geriatric, Odense University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: April 4, 2023
• Study Start: January 5, 2023
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)