Preventing Hospital Associated Disability in Older Patients: Individualized Nutrition and Exercise Strategy, a Feasibility Study (PrevHAD FS)

Bispebjerg Hospital

Status: Active, not recruiting

Conditions: Physical Function; Hospital Associated Deconditioning; Sarcopenia in Elderly; Malnutrition Elderly

Treatments: Other: Exercise, supervised

Study type: Interventional

Funder types: Other

Identifiers

NCT07124338

3165-00244B (Other Grant/Funding Number)

p-2025-18713

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 exercise, with or without an individualized nutritional plan and intervention, can prevent this fall in functional ability during hospital stay among older patients.

Furthermore, this study seeks to investigate if it is feasible to carry out such a exercise and nutritional intervention in a hospital setting, and to obtain viewpoints regarding exercise and nutrition during hospital stay from older patients. This study aims to produce experience for at bigger randomized controlled study expected later in 2025

Full description

Introduction 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 the combined effect of exercise and optimized nutrition/hydration will be more effective compared to exercise and standard care, and additionally improve the nutritional and hydrational status and lower risk of delirium during hospital stay.

Before initiating a large scale RCT, a study examining the feasibility of the design will be performed.

The Feasibility-pilot study will include 25 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 and quality of life. The Participants will receive 2 x 30 supervised exercis and a personalized nutritional plan, including refeeding risk management. In addition, the participants will be interviewed approximately 20 minutes the day before discharge. Based on predefined progression criteria using the traffic light model and qualitative feedback from the participants obtained from interviews and a new power calculation of sample size based on representative baseline characteristics, changes to design in the following RCT will be made.

Enrollment: 25 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
• Requiring specialized diet (allergies, diseases requiring special diets, aiming to lose weight)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Exercise and nutrition intrvention

Experimental group

Description:

During hospitalization, 2x 30 minutes of supervised exercise. Furthermore during hospitalization, an inital nutrition plan by a trained dietician, based on Nutrional risk, identifying of nutrion impact symtomes, daily nutritional intake regristration and adjustments to the nutrion plan

Treatment:

Other: Exercise, supervised