NCT07124338

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Jul 2025Nov 2026

Study Start

First participant enrolled

July 1, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 15, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Expected
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

July 3, 2025

Last Update Submit

January 20, 2026

Conditions

Keywords

OlderHospitalizedhospital associated disabilitySarcopeniaMalnutritionNutritional interventionExercise intervention

Outcome Measures

Primary Outcomes (1)

  • Eligibility to enter the study

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

    on inclusion day

Secondary Outcomes (18)

  • Inclusion and recruitment

    on inclusion day

  • Adherence to protocol: Exercise team workflow

    From inclusion to discharge from the geriatric department, varying fror each participant, but estimated 3-14 days.

  • Adherence to protocol: Exercise outcome

    From inclusion to discharge from the geriatric department, varying fror each participant, but estimated 3-14 days.

  • Adherence to protocol: Dietician workflow

    Inclusion day

  • Adherence to protocol: Nutrition outcome

    Four days after inclusion

  • +13 more secondary outcomes

Study Arms (1)

Exercise and nutrition intrvention

EXPERIMENTAL

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

Other: Exercise, supervised

Interventions

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

Exercise and nutrition intrvention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Moderate to severe Dementia¨
  • Manifest delirium
  • Requiring specialized diet (allergies, diseases requiring special diets, aiming to lose weight)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, Capital Region, 2400, Denmark

Location

MeSH Terms

Conditions

SarcopeniaMalnutrition

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Charlotte Suetta, Professor

    Geriatric research unit, Bispebjerg hospital, Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Feasibility Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 3, 2025

First Posted

August 15, 2025

Study Start

July 1, 2025

Primary Completion

November 30, 2025

Study Completion (Estimated)

November 30, 2026

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

We will share the protocol for the exercise and nutrional intervention, As well as participants charecteristics and outcome data, in a data repository, when the data can be fully anonymized

Access Criteria
Data repository, URL link within the published feasibility study

Locations