Active, Not Recruiting

NCT Number: NCT07124338

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Sarcopenia in Elderly Atrophy Hospital Associated Deconditioning Malnutrition Malnutrition Elderly Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Physical Function Sarcopenia Signs and Symptoms

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

About this study

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.

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
Requiring specialized diet (allergies, diseases requiring special diets, aiming to lose weight)

Treatment and study plan

Exercise, supervised

Other

nital nutrition plan by a trained dietician, based on Nutritional risk, identifying of nutrion impact symtomes, daily nutritional intake regristration and adjustments to the nutrion plan

Primary outcomes

Eligibility to enter the study

Time frame: on inclusion day

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

Secondary outcomes

Inclusion and recruitment

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Inclusion day

95 % or more of participants in nutrition intervention group receiving an individualized nutritional plan on inclusion day
Adherence to protocol: Nutrition outcome

Time frame: Four days after inclusion

80 % of participants with 75 % or more of planned daily caloric intake 4 days after admission
Outcome data: Barthel index 100

Time frame: 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)

Time frame: 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

Time frame: 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.
Assessment duration

Time frame: 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
Dropout

Time frame: 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

Time frame: 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)
Outcome data: Secondary (Hand grip strength )

Time frame: 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 )

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

University of Copenhagen

Registry information

Acronym: PrevHAD FS

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Aug 15, 2025
Registry last updated: Jan 22, 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.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting