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NCT Number: NCT07373587

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital

Copenhagen, Capital Region, 2400, Denmark

Location contact

Charlotte Suetta, Professor

CONTACT

[email protected]

Kristian Lolck, MD ph.d. student

SUB_INVESTIGATOR

Kristian V Lolck, MD, ph.d. student

CONTACT

[email protected]

+4560612914

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Moderate to severe Dementia
  • Manifest delirium

Treatment and study plan

Exercise

Other

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.

Other names: Training, Physiotheraphy

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

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

  2. 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.

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

  3. 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.

    Hand grip strength, kilogram

  4. 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.

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

  5. 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.

    Gait speed, velocity (meters/seconds)

  6. 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.

    Quadriceps muscle thickness, ultrasound, millimeters

  7. 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.

    muscle mass, bioimpedance analysis, kilogram

  8. Changes in appetite

    Time frame: From 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

  9. 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.

    quality of life, EuroQol- 5Dimensions-5 levels, questionaire, scale from 1-5 i each of five dimensions, higher scores indicates lower quality of life

  10. Readmission 30 days from discharge

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

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

  11. Mortality 30 days, 90 days and 1 year after discharge

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

    Participant diseased at 30 days, 90 days or 1 year after discharge from hospital, categorical, yes/no

  12. 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

    Need for municipal care services, number of weekly visits, minutes of care service

  13. Discharge destination

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

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

  14. Physical activity during hospitalization

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

    Steps taken and time upright, accelerometer

Study contacts

Contact information is provided by the study sponsor or research team.

Charlotte Suetta, professor

CONTACT

[email protected]

Kristian V Lolck, MD, Ph.d. student

CONTACT

[email protected]

+4560612914

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Official study title

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

Acronym: PrevHAD RCT

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 28, 2026
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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