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

March 24, 2025 updated by: Lisbeth Rosenbek Minet, Odense University Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
274

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week).
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
Baseline (Day of hospitalisation) to day of discharge from hospital (an average of a week).
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.
Change from baseline (day of hospitalisation) to 1-month follow-up and 3-months follow-up
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
Change from baseline (day of hospitalisation) to 1-month follow-up and 3-months follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week)
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)
Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week)
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
Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week)
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
Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week)
Mortality
Time Frame: Baseline (day of hospitalization) to 3-months follow-up
Administrative registers will be used to assess mortality
Baseline (day of hospitalization) to 3-months follow-up
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.
Day of discharge from hospital to 3-months follow-up
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.
Baseline (day of hospitalisation) to 3-months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Odense University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Copenhagen
Nottingham University Hospitals NHS Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Kristian B Buhl, MD, Department of Geriatric, Odense University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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