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

Not Applicable

Active, not recruiting

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

• Registration Number: NCT07124338
• Lead Sponsor: Bispebjerg Hospital

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 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

Detailed 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.

Study Timeline

• Study Start: 2025-07-01
• Study First Submitted: 2025-07-03
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-08
• Last Update Submitted: 2025-08-08
• Study First Posted: 2025-08-15
• Last Update Posted: 2025-08-15
• Primary Completion: 2025-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 25

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Eligibility to enter the study	on inclusion day	75 % or more of screened patients eligible to enter the study, based on exclusion and inclusion criteria.

Secondary Outcome Measures

Name	Time	Method
Outcome data: Barthel index 100	At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion.	90 % of included participants with data collection on planned RCT substudy 1 primary outcomes (Barthel Index 100 (0-100, 0 complete dependency in ADL function, 100 complete independence in ADL function)
Outcome data: Secondary (Cumulated Ambulation Score)	At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion.	75 % of included participants with data collection on planned RCT secondary outcomes Cumulated Ambulation Score (assesed mobility, 0-6)
Adverse effects	From inclusion to discharge from the geriatric department, varying fror each participant, but estimated 3-14 days.	No falls or function-limiting injuries related to exercise, few minor injuries. No cases of manifest refeeding syndrome related to the nutrition intervention.
Dropout	From inclusion to discharge from the geriatric department, varying fror each participant, but estimated 3-14 days.	Less than 15 % dropout of included participants
Outcome data: Primary, Knee extension strength	At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion.	90 % of included participants with data collection on planned RCT substudy 2 primary outcomes (Knee extension strength, maximal voluntary contraction, newton meter)
Inclusion and recruitment	on inclusion day	1 participant included pr weekday and more than 75% of eligible patients accept inclusion after proposal
Adherence to protocol: Exercise team workflow	From inclusion to discharge from the geriatric department, varying fror each participant, but estimated 3-14 days.	90 % of planned exercise bouts initiated.
Adherence to protocol: Exercise outcome	From inclusion to discharge from the geriatric department, varying fror each participant, but estimated 3-14 days.	85 % of initiated exercise bouts completed with 75 % of planned exercise
Adherence to protocol: Dietician workflow	Inclusion day	95 % or more of participants in nutrition intervention group receiving an individualized nutritional plan on inclusion day
Adherence to protocol: Nutrition outcome	Four days after inclusion	80 % of participants with 75 % or more of planned daily caloric intake 4 days after admission
Assessment duration	At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion.	All assessments completed faster than 120 minutes
Outcome data: Secondary (Hand grip strength )	At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion.	75 % of included participants with data collection on planned RCT secondary outcomes: Hand grip strength, kilogram
Outcome data: Secondary (Sit-to-stand test )	At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion.	75 % of included participants with data collection on planned RCT secondary outcomes: Sit-to-stand test, number of repetitions in 30 seconds, continous scale
Outcome data: Secondary (Gait speed)	At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion.	75 % of included participants with data collection on planned RCT secondary outcomes: Gait speed, velocity (meters/seconds)
Outcome data: Secondary (Quadriceps muscle thickness)	At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion.	75 % of included participants with data collection on planned RCT secondary outcomes: Quadriceps muscle thickness, ultrasound, millimeters
Outcome data: Secondary (muscle mass)	At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion.	75 % of included participants with data collection on planned RCT secondary outcomes: muscle mass, bioimpedance analysis, kilogram
Outcome data: Secondary (appetite)	At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion.	75 % of included participants with data collection on planned RCT secondary outcomes: appetite, simplified nutritional appettite questionaire.
Outcome data: Secondary (quality of life)	At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion.	75 % of included participants with data collection on planned RCT secondary outcomes: quality of life, EuroQol- 5D-5 levels questionaire

Trial Locations

Locations (1)

Bispebjerg Hospital; 🇩🇰 Copenhagen, Capital region, Denmark