Sarcopenia in ElderlyPrevHAD FSNCT07124338
Preventing Hospital Associated Disability in Older Patients: Individualized Nutrition and Exercise Strategy, a Feasibility Study
A study testing Exercise, supervised in people with Sarcopenia in Elderly and Hospital Associated Deconditioning, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
Aproximately a third of persons older than 70 years lose physical function and ability to take care of themselves during a stay at a hospital. This is associated to an increased risk of readmission and mortality. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia in Elderly, Hospital Associated Deconditioning, Malnutrition Elderly
- What is being tested?
- Exercise, supervised
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2025to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Older adult
Who may be able to join
- Hospitalized at the geriatric ward
- Speak Danish or English
- Ability to give informed consent
Who cannot join
- Moderate to severe Dementia¨
- Manifest delirium
- Requiring specialized diet (allergies, diseases requiring special diets, aiming to lose weight)
Trial locations and contacts
1 site in 1 country.
About this study
Aproximately a third of persons older than 70 years lose physical function and ability to take care of themselves during a stay at a hospital. This is associated to an increased risk of readmission and mortality. Earlier research has shown that insufficient nutrition and physical activity during hospital stay, leading to a loss in muscle mass and strength, plays an important role in this fall in functionality. This study aims to examine if a structured and supervised resistance exercise, with or without an individualized nutritional plan and intervention, can prevent this fall in functional ability during hospital stay among older patients.
Furthermore, this study seeks to investigate if it is feasible to carry out such a exercise and nutritional intervention in a hospital setting, and to obtain viewpoints regarding exercise and nutrition during hospital stay from older patients. This study aims to produce experience for at bigger randomized controlled study expected later in 2025
Read the detailed description
Introduction Older persons are highly susceptible to hospital associated disability (HAD), defined by a loss of physical function during hospitalization, leading to increased dependency, morbidity, and mortality. Key factors in developing HAD are physical inactivity, malnutrition and dehydration, leading to a decline in muscle mass and muscle strength. Therefore, there is a need to develop effective nutritional and exercise interventions for older patients, during hospitalization.
Hypothesis This study expects that a mobility-graded individualized exercise intervention will effectively prevent a decline in activities of daily living (ADL) function, mobility level, physical function, muscle and strength, and reduce the length of stay, risk of re-admission and mortality among older patients during hospital stay. The investigators furthermore hypothesize that the combined effect of exercise and optimized nutrition/hydration will be more effective compared to exercise and standard care, and additionally improve the nutritional and hydrational status and lower risk of delirium during hospital stay.
Before initiating a large scale RCT, a study examining the feasibility of the design will be performed.
The Feasibility-pilot study will include 25 participants, men and women, ≥ 65 years old from the geriatric care unit of Bispebjerg Hospital, Denmark. After inclusion, participants will have estimated nutritional status, frailty and mobility, muscle mass and strength, physical function, ADL function and quality of life. The Participants will receive 2 x 30 supervised exercis and a personalized nutritional plan, including refeeding risk management. In addition, the participants will be interviewed approximately 20 minutes the day before discharge. Based on predefined progression criteria using the traffic light model and qualitative feedback from the participants obtained from interviews and a new power calculation of sample size based on representative baseline characteristics, changes to design in the following RCT will be made.
- Conditions
- Sarcopenia in Elderly, Hospital Associated Deconditioning, Malnutrition Elderly, Physical Function
- Being tested
- Exercise, supervised
- Keywords
- Older, Hospitalized, hospital associated disability, Sarcopenia, Malnutrition, Nutritional intervention, Exercise intervention
- Medical subject headings
- Sarcopenia, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise, supervisedOther
nital nutrition plan by a trained dietician, based on Nutritional risk, identifying of nutrion impact symtomes, daily nutritional intake regristration and adjustments to the nutrion plan
| Study group | Role | What they receive |
|---|---|---|
| Exercise and nutrition intrvention | Experimental | During hospitalization, 2x 30 minutes of supervised exercise. Furthermore during hospitalization, an inital nutrition plan by a trained dietician, based on Nutrional risk, identifying of nutrion impact symtomes, daily nutritional intake regristration and adjustments to the nutrion plan Receives: Other: Exercise, supervised |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligibility to enter the study
75 % or more of screened patients eligible to enter the study, based on exclusion and inclusion criteria.
Measured: on inclusion day
Secondary outcomes (18)
Inclusion and recruitment
1 participant included pr weekday and more than 75% of eligible patients accept inclusion after proposal
Measured: on inclusion day
Adherence to protocol: Exercise team workflow
90 % of planned exercise bouts initiated.
Measured: From inclusion to discharge from the geriatric department, varying fror each participant, but estimated 3-14 days.
Adherence to protocol: Exercise outcome
85 % of initiated exercise bouts completed with 75 % of planned exercise
Measured: From inclusion to discharge from the geriatric department, varying fror each participant, but estimated 3-14 days.
Adherence to protocol: Dietician workflow
95 % or more of participants in nutrition intervention group receiving an individualized nutritional plan on inclusion day
Measured: Inclusion day
Adherence to protocol: Nutrition outcome
80 % of participants with 75 % or more of planned daily caloric intake 4 days after admission
Measured: Four days after inclusion
Outcome data: Barthel index 100
90 % of included participants with data collection on planned RCT substudy 1 primary outcomes (Barthel Index 100 (0-100, 0 complete dependency in ADL function, 100 complete independence in ADL function)
Measured: At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion.
Outcome data: Secondary (Cumulated Ambulation Score)
75 % of included participants with data collection on planned RCT secondary outcomes Cumulated Ambulation Score (assesed mobility, 0-6)
Measured: At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion.
Adverse effects
No falls or function-limiting injuries related to exercise, few minor injuries. No cases of manifest refeeding syndrome related to the nutrition intervention.
Measured: From inclusion to discharge from the geriatric department, varying fror each participant, but estimated 3-14 days.
Assessment duration
All assessments completed faster than 120 minutes
Measured: At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion.
Dropout
Less than 15 % dropout of included participants
Measured: From inclusion to discharge from the geriatric department, varying fror each participant, but estimated 3-14 days.
Outcome data: Primary, Knee extension strength
90 % of included participants with data collection on planned RCT substudy 2 primary outcomes (Knee extension strength, maximal voluntary contraction, newton meter)
Measured: At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion.
Outcome data: Secondary (Hand grip strength )
75 % of included participants with data collection on planned RCT secondary outcomes: Hand grip strength, kilogram
Measured: At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion.
Outcome data: Secondary (Sit-to-stand test )
75 % of included participants with data collection on planned RCT secondary outcomes: Sit-to-stand test, number of repetitions in 30 seconds, continous scale
Measured: At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion.
Outcome data: Secondary (Gait speed)
75 % of included participants with data collection on planned RCT secondary outcomes: Gait speed, velocity (meters/seconds)
Measured: At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion.
Outcome data: Secondary (Quadriceps muscle thickness)
75 % of included participants with data collection on planned RCT secondary outcomes: Quadriceps muscle thickness, ultrasound, millimeters
Measured: At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion.
Outcome data: Secondary (muscle mass)
75 % of included participants with data collection on planned RCT secondary outcomes: muscle mass, bioimpedance analysis, kilogram
Measured: At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion.
Outcome data: Secondary (appetite)
75 % of included participants with data collection on planned RCT secondary outcomes: appetite, simplified nutritional appettite questionaire.
Measured: At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion.
Outcome data: Secondary (quality of life)
75 % of included participants with data collection on planned RCT secondary outcomes: quality of life, EuroQol- 5D-5 levels questionaire
Measured: At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start1 Jul 2025
- Primary completion30 Nov 2025
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenia in ElderlyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility Study
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Charlotte Suetta, Bispebjerg Hospital
- Investigators
- Charlotte Suetta, Professor, Principal investigator, Geriatric research unit, Bispebjerg hospital, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124338
- Sponsor's protocol ID
- p-2025-18713
- Other IDs
- 3165-00244B
- Acronym
- PrevHAD FS
- Status last verified
- Jan 2026
- First submitted
- 3 Jul 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share the protocol for the exercise and nutrional intervention, As well as participants charecteristics and outcome data, in a data repository, when the data can be fully anonymized
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Hospital Associated Disability in Older Patients: Individualized Nutrition and Exercise Strategy, a Feasibility Study
- ClinicalTrials.gov ID
- NCT07124338
- Acronym / sponsor ID
- PrevHAD FS / p-2025-18713
- Conditions
- Sarcopenia in Elderly, Hospital Associated Deconditioning, Malnutrition Elderly, Physical Function
- Keywords
- Older, Hospitalized, hospital associated disability, Sarcopenia, Malnutrition, Nutritional intervention, Exercise intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 15 Aug 2025 (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.
Aproximately a third of persons older than 70 years lose physical function and ability to take care of themselves during a stay at a hospital. This is associated to an increased risk of readmission and mortality. Earlier research has shown that insufficient nutrition and physical activity during hospital stay, leading to a loss in muscle mass and strength, plays an important role in this fall in functionality. This study aims to examine if a structured and supervised resistance exercise, with or without an individualized nutritional plan and intervention, can prevent this fall in functional ability during hospital stay among older patients.
Furthermore, this study seeks to investigate if it is feasible to carry out such a exercise and nutritional intervention in a hospital setting, and to obtain viewpoints regarding exercise and nutrition during hospital stay from older patients. This study aims to produce experience for at bigger randomized controlled study expected later in 2025
Detailed description
Introduction Older persons are highly susceptible to hospital associated disability (HAD), defined by a loss of physical function during hospitalization, leading to increased dependency, morbidity, and mortality. Key factors in developing HAD are physical inactivity, malnutrition and dehydration, leading to a decline in muscle mass and muscle strength. Therefore, there is a need to develop effective nutritional and exercise interventions for older patients, during hospitalization.
Hypothesis This study expects that a mobility-graded individualized exercise intervention will effectively prevent a decline in activities of daily living (ADL) function, mobility level, physical function, muscle and strength, and reduce the length of stay, risk of re-admission and mortality among older patients during hospital stay. The investigators furthermore hypothesize that the combined effect of exercise and optimized nutrition/hydration will be more effective compared to exercise and standard care, and additionally improve the nutritional and hydrational status and lower risk of delirium during hospital stay.
Before initiating a large scale RCT, a study examining the feasibility of the design will be performed.
The Feasibility-pilot study will include 25 participants, men and women, ≥ 65 years old from the geriatric care unit of Bispebjerg Hospital, Denmark. After inclusion, participants will have estimated nutritional status, frailty and mobility, muscle mass and strength, physical function, ADL function and quality of life. The Participants will receive 2 x 30 supervised exercis and a personalized nutritional plan, including refeeding risk management. In addition, the participants will be interviewed approximately 20 minutes the day before discharge. Based on predefined progression criteria using the traffic light model and qualitative feedback from the participants obtained from interviews and a new power calculation of sample size based on representative baseline characteristics, changes to design in the following RCT will be made.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility Study
| Arm | Type | Receives |
|---|---|---|
| Exercise and nutrition intrvention | Experimental | Other: Exercise, supervisedDuring hospitalization, 2x 30 minutes of supervised exercise. Furthermore during hospitalization, an inital nutrition plan by a trained dietician, based on Nutrional risk, identifying of nutrion impact symtomes, daily nutritional intake regristration and adjustments to the nutrion plan |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Hospitalized at the geriatric ward
- Speak Danish or English
- Ability to give informed consent
Key exclusion criteria (3 listed)
- Moderate to severe Dementia¨
- Manifest delirium
- Requiring specialized diet (allergies, diseases requiring special diets, aiming to lose weight)
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 |
|---|---|---|
| Exercise, supervisednital nutrition plan by a trained dietician, based on Nutritional risk, identifying of nutrion impact symtomes, daily nutritional intake regristration and adjustments to the nutrion plan | Other | Exercise and nutrition intrvention |
Primary outcome
Eligibility to enter the study
Time frame: on inclusion day
75 % or more of screened patients eligible to enter the study, based on exclusion and inclusion criteria.
18 secondary outcomes
Inclusion and recruitment
Time frame: on inclusion day
Adherence to protocol: Exercise team workflow
Time frame: From inclusion to discharge from the geriatric department, varying fror each participant, but estimated 3-14 days.
Adherence to protocol: Exercise outcome
Time frame: From inclusion to discharge from the geriatric department, varying fror each participant, but estimated 3-14 days.
Adherence to protocol: Dietician workflow
Time frame: Inclusion day
Adherence to protocol: Nutrition outcome
Time frame: Four days after inclusion
Outcome data: Barthel index 100
Time frame: At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion.
Outcome data: Secondary (Cumulated Ambulation Score)
Time frame: At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion.
Adverse effects
Time frame: From inclusion to discharge from the geriatric department, varying fror each participant, but estimated 3-14 days.
Assessment duration
Time frame: At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion.
Dropout
Time frame: From inclusion to discharge from the geriatric department, varying fror each participant, but estimated 3-14 days.
Outcome data: Primary, Knee extension strength
Time frame: At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion.
Outcome data: Secondary (Hand grip strength )
Time frame: At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion.
Outcome data: Secondary (Sit-to-stand test )
Time frame: At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion.
Outcome data: Secondary (Gait speed)
Time frame: At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion.
Outcome data: Secondary (Quadriceps muscle thickness)
Time frame: At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion.
Outcome data: Secondary (muscle mass)
Time frame: At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion.
Outcome data: Secondary (appetite)
Time frame: At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion.
Outcome data: Secondary (quality of life)
Time frame: At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: Yes. We will share the protocol for the exercise and nutrional intervention, As well as participants charecteristics and outcome data, in a data repository, when the data can be fully anonymized
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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.
Charlotte Suetta, Professor principal investigator
Geriatric research unit, Bispebjerg hospital, Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, supervised in people with Sarcopenia in Elderly and Hospital Associated Deconditioning, run by Bispebjerg 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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 22 Jan 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Eligibility to enter the study (time frame: on inclusion day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2026.