ClinicalTrials.gg
RecruitingNCT07373587PrevHAD RCTUpdated Sep 30, 2026

Preventing Hospital Associated Disability in Older Patients: Individualized Nutrition and Exercise Strategy

An interventional study of Exercise in Sarcopenia in Elderly, Hospital Associated Disability and Malnutrition Elderly, sponsored by Bispebjerg Hospital. Recruiting at 1 site in Denmark. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Bispebjerg Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Feb 2026; still recruiting 9 months later.
Updated Sep 30, 2026Now RecruitingSite recruiting status changed+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
360
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Sarcopenia in Elderly
  • Hospital Associated Disability
  • Malnutrition Elderly
  • Physical Function

Keywords

  • Older
  • Hospitalized
  • Sarcopenia
  • Malnutrition
  • Exercise intervention
03

In context

Sarcopenia

1,329 studies on the registry are indexed under Sarcopenia; 420 are open to participants now.

This study's planned enrollment of 360 is above the median of 60 across 855 interventional studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

Bispebjerg Hospital is the lead sponsor of 289 studies on the registry; 29 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
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Hospitalized at the geriatric ward
  • Speak Danish or English
  • Ability to give

Exclusion criteria

Exclusion Criteria:

  • Moderate to severe Dementia
  • Manifest delirium
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
360 participants (estimated)

Study arms

  • No intervention
    Control

    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.

  • Experimental
    Exercise intervention

    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.

    Other: Exercise

Interventions

  • OtherExercise

    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.

    Also known as: Training, Physiotheraphy

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.

Secondary outcomes

  1. Changes in mobility by Cumulated Ambulation Score

    Cumulated Ambulation Score (assesed mobility, 0 (lowest)-6(highest))

    Time frame: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge

  2. Changes in Knee extension strength,

    (Knee extension strength, maximal voluntary contraction, newton meter)

    Time frame: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.

  3. Changes in Hand Grip Strength

    Hand grip strength, kilogram

    Time frame: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.

  4. Changes in Sit-to-stand performance

    Sit-to-stand test, number of repetitions in 30 seconds, continous scale

    Time frame: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.

  5. Changes in Gait speed

    Gait speed, velocity (meters/seconds)

    Time frame: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.

  6. Changes in Quadriceps muscle thickness

    Quadriceps muscle thickness, ultrasound, millimeters

    Time frame: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.

  7. Changes in muscle mass

    muscle mass, bioimpedance analysis, kilogram

    Time frame: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.

  8. Changes in appetite

    appetite, simplified nutritional appettite questionaire. Scale, 4-20, lower values indicates higher risk of insufficient nutritional intake

    Time frame: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.

  9. 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

    Time frame: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.

  10. Readmission 30 days from discharge

    Participants readmitted to the hospital within 30 days of discharge, categorical yes or no

    Time frame: From inclusion to 30 days after discharge from hospital

  11. 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

    Time frame: From inclusion to 1 year after discharge from hospital

  12. 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

    Time frame: Retrospectively 14 days berfore inclusion to 3 months after discharge from hospital

  13. Discharge destination

    Discharged to own home, temporary rehabillitation or permanent care facility, categorical, yes or no

    Time frame: From inclusion to discharge from hospital (aproximately 5 days after inclusion)

  14. Physical activity during hospitalization

    Steps taken and time upright, accelerometer

    Time frame: From inclusion to discharge from hospital (aproximately 5 days after inclusion)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: 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

Supporting information: Study protocol, Statistical analysis plan

Time frame: When the main study is published, estimated 1. march 2028, with no end date

Access criteria: Data repository, URL link within the published study

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2026 (actual). Primary completion is estimated for Sep 2027, 19 months after the start.

Of 492 non-industry interventional studies with no phase under Sarcopenia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 34. This study's planned 19 months is close to that.

Counting every sponsor, half of 503 studies reached it within 18 months; a quarter within 8 and three quarters within 34.

Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 30, 2026: primary completion Feb 2027 → Sep 2027 and completion Feb 2028 → Sep 2028.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jan 20, 2026
First posted
Jan 28, 2026
StartActual
Feb 3, 2026
Primary completionEst.
Sep 28, 2027was Feb 2027
CompletionEst.
Sep 29, 2028was Feb 2028
Last update
Sep 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Sep 30, 2026
Sites
Bispebjerg Hospital is now Recruiting
Sep 30, 2026
Primary completion
Feb 28, 2027→Sep 28, 2027
Sep 30, 2026
Study completion
Feb 29, 2028→Sep 29, 2028
Sep 30, 2026
Show all 1 update
  1. Sep 30, 2026
    Not yet recruiting→Recruiting
    Bispebjerg Hospital is now Recruiting
    Primary completion Feb 28, 2027→Sep 28, 2027
    Study completion Feb 29, 2028→Sep 29, 2028
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07373587
Responsible party
Charlotte Suetta (Professor, Bispebjerg Hospital) — Principal investigator
First posted
Jan 28, 2026
Start date
Feb 3, 2026
Primary completion
Sep 28, 2027 (estimated)
Completion
Sep 29, 2028 (estimated)
Last update
Sep 30, 2026

Study contacts

Kristian V Lolck, MD, Ph.d. student
Contact
kristian.kaltoft.lolck@regionh.dk
+4560612914
Charlotte Suetta, professor
Contact
charlotte.suetta@regionh.dk
Charlotte Suetta, Professor
principal investigator · Geriatric research unit, Bispebjerg hospital, Copenhagen

Oversight

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

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