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CompletedNCT05798169Updated Mar 27, 2025

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

An interventional study of Resistance training in Sarcopenia, Functional Decline and Muscle Architecture, sponsored by Odense University Hospital. Completed at 1 site in Denmark. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-27.

Sponsored by Odense University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
274
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

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03

In context

Sarcopenia

1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.

This study's enrollment of 274 is above the median of 60 across 775 interventional studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

Odense University Hospital is the lead sponsor of 468 studies on the registry; 109 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
274 participants (actual)

Study arms

  • Experimental
    Intervention Group

    Group of participants receiving resistance training during hospitalisation

    Other: Resistance training

  • Sham comparator
    Control Group

    Group of participants receiving sham training during hospitalisation

    Other: Resistance training

Interventions

  • OtherResistance training

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

06

What researchers measure

Primary outcomes

  1. Change from baseline B-mode ultrasonography

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

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

  2. Change from baseline 4 meter Gait Speed Test

    Physical performance evaluated by the 4m Gait Speed test

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

  3. Change from baseline B-mode ultrasonography

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

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

  4. Change from baseline 4 meter Gait Speed Test

    Physical performance evaluated by the 4m Gait Speed test

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

Secondary outcomes

  1. 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).

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

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

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

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

  3. Change from baseline Bioimpedance

    Muscle quantity (kg) on wholebody level evaluated by Bioimpedance

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

  4. Length of hospital stay

    Number of days hospitalised

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

  5. Mortality

    Administrative registers will be used to assess mortality

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

  6. 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.

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

  7. 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.

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

07

Study locations

1 site
  • Geriatric Deparment OUH Svendborg Hospital
    Svendborg, FYN 5700, Denmark
08

References and documents

Individual participant data

Plan to share: No — No plan

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05798169
Lead sponsor
Odense University Hospital
Collaborators
University of Copenhagen, Nottingham University Hospitals NHS Trust
Responsible party
Lisbeth Rosenbek Minet (Professor, University of Southern Denmark) — Principal investigator
First posted
Apr 4, 2023
Start date
Jan 5, 2023
Primary completion
Dec 20, 2024
Completion
Dec 20, 2024
Last update
Mar 27, 2025

Study contacts

Kristian B Buhl, MD
study director · Department of Geriatric, Odense University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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