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

Preventing Hospital Associated Disability in Older Patients: Individualized Nutrition and Exercise Strategy, a Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Physical Function; Malnutrition Elderly; Sarcopenia in Elderly; Hospital Associated Disability
• Intervention / Treatment: Other: Exercise

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.

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristian V Lolck, MD, ph.d. student; Phone Number: +4560612914; Email: kristian.kaltoft.lolck@regionh.dk
• Study Contact Backup: Name: Charlotte Suetta, Professor; Email: charlotte.suetta@regionh.dk

Study Locations

• Denmark
  • Capital Region
    • Copenhagen, Capital Region, Denmark, 2400
      • Bispebjerg Hospital
      • Contact: Kristian V Lolck, MD, ph.d. student; Phone Number: +4560612914; Email: kristian.kaltoft.lolck@regionh.dk
      • Contact: Charlotte Suetta, Professor; Email: charlotte.suetta@regionh.dk
      • Sub-Investigator: Kristian Lolck, MD ph.d. student

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Moderate to severe Dementia
• Manifest delirium

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise intervention; 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.	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 without walking aids or walking on stairs.; Other Names: Training; Physiotheraphy
No Intervention: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in activities of daily living (ADL) function, by Barthel index-100	describes the level of independence in activities of daily living, score of 0 equals total dependence and a score of 100 equals total independence	From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in mobility by Cumulated Ambulation Score	Cumulated Ambulation Score (assesed mobility, 0 (lowest)-6(highest))	From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge
Changes in Knee extension strength,	(Knee extension strength, maximal voluntary contraction, newton meter)	From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.
Changes in Hand Grip Strength	Hand grip strength, kilogram	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	Sit-to-stand test, number of repetitions in 30 seconds, continous scale	From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.
Changes in Gait speed	Gait speed, velocity (meters/seconds)	From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.
Changes in Quadriceps muscle thickness	Quadriceps muscle thickness, ultrasound, millimeters	From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.
Changes in muscle mass	muscle mass, bioimpedance analysis, kilogram	From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.
Readmission 30 days from discharge	Participants readmitted to the hospital within 30 days of discharge, categorical yes or no	From inclusion to 30 days after discharge from hospital
Mortality 30 days, 90 days and 1 year after discharge	Participant diseased at 30 days, 90 days or 1 year after discharge from hospital, categorical, yes/no	From inclusion to 1 year after discharge from hospital
Changes in municipal care needs at discharge, 1 month and 3 months after discharge	Need for municipal care services, number of weekly visits, minutes of care service	Retrospectively 14 days berfore inclusion to 3 months after discharge from hospital
Discharge destination	Discharged to own home, temporary rehabillitation or permanent care facility, categorical, yes or no	From inclusion to discharge from hospital (aproximately 5 days after inclusion)
Physical activity during hospitalization	Steps taken and time upright, accelerometer	From inclusion to discharge from hospital (aproximately 5 days after inclusion)
Changes in appetite	appetite, simplified nutritional appettite questionaire. Scale, 4-20, lower values indicates higher risk of insufficient nutritional intake	From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.
Changes in quality of life	quality of life, EuroQol- 5Dimensions-5 levels, questionaire, scale from 1-5 i each of five dimensions, higher scores indicates lower quality of life	From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Investigators: Principal Investigator: Charlotte Suetta, Professor, Geriatric research unit, Bispebjerg hospital, Copenhagen

Study record dates

Study Major Dates

• Study Start (Estimated): February 3, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 29, 2028

Study Registration Dates

• First Submitted: January 20, 2026
• First Submitted That Met QC Criteria: January 20, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Sarcopenia; Hospitalized; Malnutrition; Older; Exercise intervention
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Nutrition Disorders; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Malnutrition; Sarcopenia; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: p-2026-20660; 3165-00244B (Other Grant/Funding Number: Independent Research Fund Denmark)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share the protocol for the exercise intervention, as well as participants charecteristics and outcome data, in a data repository, when the data can be fully anonymized
• IPD Sharing Time Frame: When the main study is published, estimated 1. march 2028, with no end date
• IPD Sharing Access Criteria: Data repository, URL link within the published study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No