Sarcopenia in ElderlyPrevHAD RCTNCT07373587
Preventing Hospital Associated Disability in Older Patients: Individualized Nutrition and Exercise Strategy
A study testing Exercise in people with Sarcopenia in Elderly and Hospital Associated Disability, 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 Disability, Malnutrition Elderly
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Feb 2026to 29 Sep 2028
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Charlotte Suetta, professor contact
Denmark1 site, 1 recruiting
- Recruiting
Bispebjerg Hospital
Copenhagen, Capital Region, 2400
Kristian V Lolck, MD, ph.d. student, +4560612914, kristian.kaltoft.lolck@regionh.dk
Charlotte Suetta, Professor, charlotte.suetta@regionh.dk
About this study
Official title: Preventing Hospital Associated Disability in Older Patients: Individualized Nutrition and Exercise Strategy, a Randomized Controlled Trial
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 and mobility exercise intervention, can prevent this fall in functional ability during hospital stay among older patients. The Impact of nutritional status will be investigated by registrering caloric, protein and hydtrational intake during the study period.
Read the detailed description
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 sufficcient nutrition and hydration will improve the impact of the exercise intervention. The study is designed as a randomized controlled trial, and will include 360 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, cognitive function and quality of life. Futhermore, blood samples for analysis of anabolic and inflammatory biomarkers as well as microbiome samples will be taken at baseline testing. After baseline testing, the participants will be divided randomely 1:1 into a control group and an intervention group. All participants will have nutritional and hydrational intake registered and wear accelerometers during the study period. The participants in the intervention group will receive 2 x 30 minutes supervised exercise (resistance and mobility) every day during the stury period. At discharge or transfer from the geriatric care unit, participants will be tested for mobility, muscle mass and strength, physical function, ADL function, cognitive function and quality of life. 1 Month after discharge from hospital, the participants will recieve af telefon interview, reporting on ADL-function, mobility, quality of life and nutritional status. Participants succesfully reached by telephone interview, will be asked further permission for a homevisit, where muscle strength and mass, physical function, mobility, cognitive function and ADL function will be evaluated.
- Conditions
- Sarcopenia in Elderly, Hospital Associated Disability, Malnutrition Elderly, Physical Function
- Being tested
- Exercise
- Keywords
- Older, Hospitalized, Sarcopenia, Malnutrition, 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.
ExerciseOther
Also called Training, Physiotheraphy
The participants in the intervention group will recieve supervised exercise two times 30 minutes each day during hospitalization. The first exercise pass consists of resistance exercise, and can be performed supine in bed, sitting on the edge of the bed, and in a close-by exercise area, based on participants mobility level. The second exercise pass consists of mobility exercise, aiming to transfer the participant from supine in the bed to sitting position, transfer to chair, walking with or without walking aids or walking on stairs.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control group will recieve usual care at the geriatric care unit, with mobility exercise performed based on individual preferences and ability, performed by regular care personelle and regular physiotherapy staff. |
| Exercise intervention | Experimental | The exercise intervention group will recieve two times 30 minutes of supervised exercise (mobility and resistance exercise) every day during their stay at the geriatrich care unit. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in activities of daily living (ADL) function, by Barthel index-100
describes the level of independence in activities of daily living, score of 0 equals total dependence and a score of 100 equals total independence
Measured: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.
Secondary outcomes (14)
Changes in mobility by Cumulated Ambulation Score
Cumulated Ambulation Score (assesed mobility, 0 (lowest)-6(highest))
Measured: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge
Changes in Knee extension strength,
(Knee extension strength, maximal voluntary contraction, newton meter)
Measured: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.
Changes in Hand Grip Strength
Hand grip strength, kilogram
Measured: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.
Changes in Sit-to-stand performance
Sit-to-stand test, number of repetitions in 30 seconds, continous scale
Measured: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.
Changes in Gait speed
Gait speed, velocity (meters/seconds)
Measured: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.
Changes in Quadriceps muscle thickness
Quadriceps muscle thickness, ultrasound, millimeters
Measured: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.
Changes in muscle mass
muscle mass, bioimpedance analysis, kilogram
Measured: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.
Changes in appetite
appetite, simplified nutritional appettite questionaire. Scale, 4-20, lower values indicates higher risk of insufficient nutritional intake
Measured: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.
Changes in quality of life
quality of life, EuroQol- 5Dimensions-5 levels, questionaire, scale from 1-5 i each of five dimensions, higher scores indicates lower quality of life
Measured: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.
Readmission 30 days from discharge
Participants readmitted to the hospital within 30 days of discharge, categorical yes or no
Measured: From inclusion to 30 days after discharge from hospital
Mortality 30 days, 90 days and 1 year after discharge
Participant diseased at 30 days, 90 days or 1 year after discharge from hospital, categorical, yes/no
Measured: From inclusion to 1 year after discharge from hospital
Changes in municipal care needs at discharge, 1 month and 3 months after discharge
Need for municipal care services, number of weekly visits, minutes of care service
Measured: Retrospectively 14 days berfore inclusion to 3 months after discharge from hospital
Discharge destination
Discharged to own home, temporary rehabillitation or permanent care facility, categorical, yes or no
Measured: From inclusion to discharge from hospital (aproximately 5 days after inclusion)
Physical activity during hospitalization
Steps taken and time upright, accelerometer
Measured: From inclusion to discharge from hospital (aproximately 5 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 posted28 Jan 2026
- Study start3 Feb 2026
- Primary completion28 Sep 2027 (estimated)
- Study completion29 Sep 2028 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- 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
- NCT07373587
- Sponsor's protocol ID
- p-2026-20660
- Other IDs
- 3165-00244B
- Acronym
- PrevHAD RCT
- Status last verified
- Sep 2026
- First submitted
- 20 Jan 2026
- Last updated
- 30 Sep 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 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 30 Sep 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 Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07373587
- Acronym / sponsor ID
- PrevHAD RCT / p-2026-20660
- Conditions
- Sarcopenia in Elderly, Hospital Associated Disability, Malnutrition Elderly, Physical Function
- Keywords
- Older, Hospitalized, Sarcopenia, Malnutrition, Exercise intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- 28 Sep 2027 (estimated)
- Study completion
- 29 Sep 2028 (estimated)
- First posted
- 28 Jan 2026 (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 and mobility exercise intervention, can prevent this fall in functional ability during hospital stay among older patients. The Impact of nutritional status will be investigated by registrering caloric, protein and hydtrational intake during the study period.
Detailed description
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 sufficcient nutrition and hydration will improve the impact of the exercise intervention. The study is designed as a randomized controlled trial, and will include 360 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, cognitive function and quality of life. Futhermore, blood samples for analysis of anabolic and inflammatory biomarkers as well as microbiome samples will be taken at baseline testing. After baseline testing, the participants will be divided randomely 1:1 into a control group and an intervention group. All participants will have nutritional and hydrational intake registered and wear accelerometers during the study period. The participants in the intervention group will receive 2 x 30 minutes supervised exercise (resistance and mobility) every day during the stury period. At discharge or transfer from the geriatric care unit, participants will be tested for mobility, muscle mass and strength, physical function, ADL function, cognitive function and quality of life. 1 Month after discharge from hospital, the participants will recieve af telefon interview, reporting on ADL-function, mobility, quality of life and nutritional status. Participants succesfully reached by telephone interview, will be asked further permission for a homevisit, where muscle strength and mass, physical function, mobility, cognitive function and ADL function will be evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group will recieve usual care at the geriatric care unit, with mobility exercise performed based on individual preferences and ability, performed by regular care personelle and regular physiotherapy staff. |
| Exercise intervention | Experimental | Other: ExerciseThe exercise intervention group will recieve two times 30 minutes of supervised exercise (mobility and resistance exercise) every day during their stay at the geriatrich care unit. |
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 (2 listed)
- Moderate to severe Dementia
- Manifest delirium
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 |
|---|---|---|
| ExerciseAlso: Training, PhysiotheraphyThe participants in the intervention group will recieve supervised exercise two times 30 minutes each day during hospitalization. The first exercise pass consists of resistance exercise, and can be performed supine in bed, sitting on the edge of the bed, and in a close-by exercise area, based on participants mobility level. The second exercise pass consists of mobility exercise, aiming to transfer the participant from supine in the bed to sitting position, transfer to chair, walking with or without walking aids or walking on stairs. | Other | Exercise intervention |
Primary outcome
Changes in activities of daily living (ADL) function, by Barthel index-100
Time frame: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.
describes the level of independence in activities of daily living, score of 0 equals total dependence and a score of 100 equals total independence
14 secondary outcomes
Changes in mobility by Cumulated Ambulation Score
Time frame: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge
Changes in Knee extension strength,
Time frame: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.
Changes in Hand Grip Strength
Time frame: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.
Changes in Sit-to-stand performance
Time frame: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.
Changes in Gait speed
Time frame: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.
Changes in Quadriceps muscle thickness
Time frame: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.
Changes in muscle mass
Time frame: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.
Changes in appetite
Time frame: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.
Changes in quality of life
Time frame: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.
Readmission 30 days from discharge
Time frame: From inclusion to 30 days after discharge from hospital
Mortality 30 days, 90 days and 1 year after discharge
Time frame: From inclusion to 1 year after discharge from hospital
Changes in municipal care needs at discharge, 1 month and 3 months after discharge
Time frame: Retrospectively 14 days berfore inclusion to 3 months after discharge from hospital
Discharge destination
Time frame: From inclusion to discharge from hospital (aproximately 5 days after inclusion)
Physical activity during hospitalization
Time frame: From inclusion to discharge from hospital (aproximately 5 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 30 Sep 2026.
- Individual participant dataSharing planned: Yes. We will share the protocol for the exercise intervention, as well as participants charecteristics and outcome data, in a data repository, when the data can be fully anonymized
Related trials for Sarcopenia in Elderly
Not yet recruiting
PROfiles of FGF-19 Post-prandial Secretion in Older Adults With Frailty and Without Frailty
Frailty, Sarcopenia
Recruiting
Effects of a Community-based Multicomponent Physical Exercise Program on Physical Function, Frailty, and Sarcopenia in Older Adults From the Municipality of Santoña: a Quasi-experimental Study.
Frailty/Sarcopenia, Frailty in Older Adults
Not yet recruitingObservational study
Preoperative Muscle Stiffness, Functional Reserve, and Postoperative Quality of Recovery in Lower Extremity Arthroplasty
Osteoarthritis (Knee / Hip), Sarcopenia
Enrolling by invitationObservational study
Multidimensional Determinants of Functional Health In Women Aged 45-60
Healthy, Perimenopausal Depression
RecruitingObservational study
Functional Decline and Quality of Life After Gastrointestinal Cancer Surgery in Older Adults
Cancer Abdomen, Elderly (People Aged 65 or More)
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.
Charlotte Suetta, professor contact
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 in people with Sarcopenia in Elderly and Hospital Associated Disability, 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 2 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: looking for participants now, as of the sponsor's last update on 30 Sep 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?
Contact Kristian V Lolck, MD, Ph.d. student (+4560612914, kristian.kaltoft.lolck@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in activities of daily living (ADL) function, by Barthel index-100 (time frame: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.). 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 30 Sep 2026.