SarcopeniaNCT05798169
Impact of Acute Hospitalisation and Resistance Training on Muscle Architecture and Physical Performance in Older Adults
A study testing Resistance training in people with Sarcopenia and Functional Decline, run by Odense University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Functional Decline, Muscle Architecture
- What is being tested?
- Resistance training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 274 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Jan 2023to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- ≥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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Resistance training
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingOther
Moderate resistance training by a innovative training robot 2 times a day during hospitalisation
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Group of participants receiving resistance training during hospitalisation Receives: Other: Resistance training |
| Control Group | Sham comparator | Group of participants receiving sham training during hospitalisation Receives: Other: Resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline B-mode ultrasonography
Muscle architecture of the m Vastus Lateralis assessed with B-mode ultrasonography.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Maximal muscle strength of the lower extremities evaluated by the 30s Chair Stand Test or the m30s Chair Stand Test (Modified).
Measured: Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week)
Change from baseline Barthel-Index 100 (Shahs version)
Functional level evaluated by The Barthel-Index 100 (Shahs version)
Measured: Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week)
Change from baseline Bioimpedance
Muscle quantity (kg) on wholebody level evaluated by Bioimpedance
Measured: Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week)
Length of hospital stay
Number of days hospitalised
Measured: Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week)
Mortality
Administrative registers will be used to assess mortality
Measured: Baseline (day of hospitalization) to 3-months follow-up
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.
Measured: Day of discharge from hospital to 3-months follow-up
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.
Measured: Baseline (day of hospitalisation) to 3-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start5 Jan 2023
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Nottingham University Hospitals NHS Trust
- Responsible party
- Principal investigator, Lisbeth Rosenbek Minet, University of Southern Denmark
- Investigators
- Kristian B Buhl, MD, Study director, Department of Geriatric, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798169
- Sponsor's protocol ID
- ARTMAP
- Status last verified
- Mar 2025
- First submitted
- 7 Nov 2022
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan
Publications
Phillip JG, Oddsson HR, Ryg J, Suetta C, Masud T, Minet LR. Unraveling physical performance over time in hospitalized older patients with walking limitation: the role of ultrasound-derived vastus lateralis muscle thickness. Geroscience. 2026 Jun 25. doi: 10.1007/s11357-026-02384-8. Online ahead of print.
PubMed 42347914
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Acute Hospitalisation and Resistance Training on Muscle Architecture and Physical Performance in Older Adults
- ClinicalTrials.gov ID
- NCT05798169
- Acronym / sponsor ID
- ARTMAP
- Conditions
- Sarcopenia, Functional Decline, Muscle Architecture, Gait Speed, Ultrasound, Physical Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen, Nottingham University Hospitals NHS Trust
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Resistance trainingGroup of participants receiving resistance training during hospitalisation |
| Control Group | Sham comparator | Other: Resistance trainingGroup of participants receiving sham training during hospitalisation |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- ≥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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance trainingModerate resistance training by a innovative training robot 2 times a day during hospitalisation | Other | Control Group, Intervention Group |
Primary outcome
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.
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
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 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
7 secondary outcomes
Change from baseline 30s Chair Stand test
Time frame: 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)
Change from baseline Bioimpedance
Time frame: 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)
Mortality
Time frame: Baseline (day of hospitalization) to 3-months follow-up
Unplanned hospitalisation
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Derived from this study: PubMed 42347914Phillip JG, Oddsson HR, Ryg J, Suetta C, Masud T, Minet LR. Unraveling physical performance over time in hospitalized older patients with walking limitation: the role of ultrasound-derived vastus lateralis muscle thickness. Geroscience. 2026 Jun 25. doi: 10.1007/s11357-026-02384-8. Online ahead of print.
- Individual participant dataSharing planned: No. No plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristian B Buhl, MD study director
Department of Geriatric, Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training in people with Sarcopenia and Functional Decline, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline B-mode ultrasonography (time frame: Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05798169, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.