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Preventing Hospital Associated Disability in Older Patients: Individualized Nutrition and Exercise Strategy (PrevHAD RCT)

B

Bispebjerg Hospital

Status

Not yet enrolling

Conditions

Physical Function
Sarcopenia in Elderly
Malnutrition Elderly
Hospital Associated Disability

Treatments

Other: Exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT07373587
p-2026-20660
3165-00244B (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

360 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Moderate to severe Dementia
  • Manifest delirium

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

360 participants in 2 patient groups

Control
No Intervention group
Description:
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 group
Description:
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.
Treatment:
Other: Exercise

Trial contacts and locations

1

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Central trial contact

Kristian V Lolck, MD, Ph.d. student; Charlotte Suetta, professor

Data sourced from clinicaltrials.gov

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