Preventing Hospital Associated Disability in Older Patients: Individualized Nutrition and Exercise Strategy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise.
- Who it may be relevant to
- Registry conditions: Sarcopenia in Elderly, Hospital Associated Disability, Malnutrition Elderly, Physical Function. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Preventing Hospital Associated Disability in Older Patients: Individualized Nutrition and Exercise Strategy, a Randomized Controlled Trial
Overview
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
- Other Exercise
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 with
Primary outcome measures
- 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.]
Secondary outcome measures (12)
- 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]
Eligibility criteria
Inclusion criteria
- Hospitalized at the geriatric ward
- Speak Danish or English
- Ability to give informed consent
Exclusion criteria
- Moderate to severe Dementia
- Manifest delirium
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Denmark · 1 center
- Bispebjerg Hospital — Copenhagen
Identifiers
NCT: NCT07373587 · p-2026-20660 · 3165-00244B