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

Preventing Hospital Associated Disability in Older Patients: Individualized Nutrition and Exercise Strategy, a Randomized Controlled Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07373587
Acronym
PrevHAD RCT
Enrollment
360
Registered
2026-01-28
Start date
2026-02-03
Completion date
2028-02-29
Last updated
2026-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Older, Hospitalized, Sarcopenia, Malnutrition, Exercise intervention

Brief 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.

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.

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.

Sponsors

Bispebjerg Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Masking description

Outcomes at discharge will be measured by a different investigator than at baseline, to mask the baseline measures.

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Hospitalized at the geriatric ward * Speak Danish or English * Ability to give informed consent

Exclusion criteria

* Moderate to severe Dementia * Manifest delirium

Design outcomes

Primary

MeasureTime frameDescription
Changes in activities of daily living (ADL) function, by Barthel index-100From 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

Secondary

MeasureTime frameDescription
Changes in mobility by Cumulated Ambulation ScoreFrom enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after dischargeCumulated Ambulation Score (assesed mobility, 0 (lowest)-6(highest))
Changes in Knee extension strength,From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.(Knee extension strength, maximal voluntary contraction, newton meter)
Changes in Hand Grip StrengthFrom enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.Hand grip strength, kilogram
Changes in Sit-to-stand performanceFrom enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.Sit-to-stand test, number of repetitions in 30 seconds, continous scale
Changes in Gait speedFrom enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.Gait speed, velocity (meters/seconds)
Changes in Quadriceps muscle thicknessFrom enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.Quadriceps muscle thickness, ultrasound, millimeters
Changes in muscle massFrom enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.muscle mass, bioimpedance analysis, kilogram
Changes in appetiteFrom enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.appetite, simplified nutritional appettite questionaire. Scale, 4-20, lower values indicates higher risk of insufficient nutritional intake
Changes in quality of lifeFrom enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.quality of life, EuroQol- 5Dimensions-5 levels, questionaire, scale from 1-5 i each of five dimensions, higher scores indicates lower quality of life
Readmission 30 days from dischargeFrom inclusion to 30 days after discharge from hospitalParticipants readmitted to the hospital within 30 days of discharge, categorical yes or no
Mortality 30 days, 90 days and 1 year after dischargeFrom inclusion to 1 year after discharge from hospitalParticipant diseased at 30 days, 90 days or 1 year after discharge from hospital, categorical, yes/no
Changes in municipal care needs at discharge, 1 month and 3 months after dischargeRetrospectively 14 days berfore inclusion to 3 months after discharge from hospitalNeed for municipal care services, number of weekly visits, minutes of care service
Discharge destinationFrom inclusion to discharge from hospital (aproximately 5 days after inclusion)Discharged to own home, temporary rehabillitation or permanent care facility, categorical, yes or no
Physical activity during hospitalizationFrom inclusion to discharge from hospital (aproximately 5 days after inclusion)Steps taken and time upright, accelerometer

Countries

Denmark

Contacts

CONTACTKristian V Lolck, MD, Ph.d. student
kristian.kaltoft.lolck@regionh.dk+4560612914
CONTACTCharlotte Suetta, professor
charlotte.suetta@regionh.dk
PRINCIPAL_INVESTIGATORCharlotte Suetta, Professor

Geriatric research unit, Bispebjerg hospital, Copenhagen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026