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OpenTrials
Completed

NCT Number: NCT05798169

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resistance training

Other

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

Primary outcomes

  1. Change from baseline B-mode ultrasonography

    Time frame: Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week).

    Muscle architecture of the m Vastus Lateralis assessed with B-mode ultrasonography.

  2. Change from baseline 4 meter Gait Speed Test

    Time frame: Baseline (Day of hospitalisation) to day of discharge from hospital (an average of a week).

    Physical performance evaluated by the 4m Gait Speed test

  3. Change from baseline B-mode ultrasonography

    Time frame: Change from baseline (day of hospitalisation) to 1-month follow-up and 3-months follow-up

    Muscle architecture of the muscle vastus lateralis assessed with B-mode ultrasonography.

  4. Change from baseline 4 meter Gait Speed Test

    Time frame: Change from baseline (day of hospitalisation) to 1-month follow-up and 3-months follow-up

    Physical performance evaluated by the 4m Gait Speed test

Secondary outcomes

  1. Change from baseline 30s Chair Stand test

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

    Maximal muscle strength of the lower extremities evaluated by the 30s Chair Stand Test or the m30s Chair Stand Test (Modified).

  2. Change from baseline Barthel-Index 100 (Shahs version)

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

    Functional level evaluated by The Barthel-Index 100 (Shahs version)

  3. Change from baseline Bioimpedance

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

    Muscle quantity (kg) on wholebody level evaluated by Bioimpedance

  4. Length of hospital stay

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

    Number of days hospitalised

  5. Mortality

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

    Administrative registers will be used to assess mortality

  6. Unplanned hospitalisation

    Time frame: Day of discharge from hospital to 3-months follow-up

    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.

  7. Individual level of physiotherapy

    Time frame: Baseline (day of hospitalisation) to 3-months follow-up

    Adminstrative registers and municipalities health records will be used to assess the individual level of physiotherapy (minutes of consultation) in the period of inclusion.

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Nottingham University Hospitals NHS Trust
  • University of Copenhagen

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 4, 2023
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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