Clinical trial NCT05442892: Use of Near Infrared Spectroscopy (NIRS) as a Biomarker of Delirium in Hospitalized Older Adults Doing Physical Exercise
Official title: Use of Near Infrared Spectroscopy (NIRS) as a Biomarker of Delirium in Hospitalized Older Adults Applied to a Multicomponent Program Based on Physical Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium
Keywords: physical exercise
multicomponent intervention
geriatric acute unit
older adults
Lead sponsor: Fundacion Miguel Servet
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 36
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Delirium is an important cause of morbimortality in older adults admitted to hospital. Multicomponent interventions targeting delirium risk factors, including physical exercise and mobilization, have been shown to reduce delirium incidence in 30-40% in acute care setting but little is known about its role in the evolution of delirium, once established.

This study is a randomized clinical trial conducted in the Acute Geriatric Unit of a tertiary public hospital in Navarra, Spain. Hospitalized delirious patients who meet the inclusion criteria will be randomly assigned to the intervention or control group. The intervention will consist of a multicomponent exercise training programme, which will be composed of supervised progressive resistance and strength exercise training during 4 consecutive days. The objective is to assess the effectiveness of this intervention in reducing the following primary outcomes: duration and severity of delirium, functional status, and length of stay.

This study will contribute to determine the usefulness of physical exercise in the management of delirium. It will be the first study to evaluate the impact of a multicomponent intervention based on physical exercise in the evolution of delirium.

Detailed description: This study is a randomized clinical trial conducted in the Acute Geriatric Unit of Navarra University Hospital (Pamplona, Spain) with 40 beds allocated. Hospitalized patients who meet the inclusion criteria will be randomly assigned to the intervention or control group. After signing an informed consent form, the participants will be randomly assigned to either the intervention or control group. The data for both the intervention and the control group will be obtained at five different times: the initial visit during the acute hospitalization, at discharge and at one, three and twelve months after discharge through phone call and clinical history. Adverse events, including muscle pain, fatigue, falls and general aches will be recorded by the training staff.

Delirium will be assessed using the European Spanish version of the 4AT daily during hospitalization until discharge. This tool has been validated for the Spanish population and is a reliable instrument for delirium detection in older patients. Delirium severity will be evaluated with the Memorial Delirium Assessment Scale (MDAS) which is also validated in Spain.

Therefore, brain function will be examinated during delirium and the effects of an intra-hospital exercise program on the prefrontal cortex region and also on muscle function with the use of functional near-infrared spectroscopy imaging (NIRS). Regional cerebral oxygen saturation (Scto2) will be recorded using NIRS through the NIRO-200NX C10448 monitor (Hamamatsu, Japan) by placing one optode on the patient's forehead above the eyebrow (contralateral to the dominant hand) and the other optode on the vastus lateralis muscle. The measurements will be made with the patients resting in the sitting position after 60 seconds, doing trail making test part A and physical exercise at the beginning of the study and at the 4th day of the study, in both intervention and control group.

Eligibility criteria: Inclusion Criteria:

* Patients \> 75 years admitted to the Geriatric Service of the Navarra University Hospital for at least 4 days

Exclusion Criteria:

* Refusal to sign the informed consent by the patient/primary caregiver/legal representative or inability to obtain it
* Advanced dementia GDS 6-7
* Moderate functional impairment (Barthel Index less than 45)
* Life expectancy less than 3 months
* Facial dermal pathology
* Acute intracranial pathology (hemorrhages, cerebral infarcts)
* Recent acute myocardial infarction
* Unstable angina
* Severe heart valve insufficiency
* Arrhythmia or uncontrolled arterial hypertension
* Recent pulmonary thromboembolism
* Hemodynamic instability

Primary outcomes:
measure: Changes in the 4 'A's Test (4AT scale Spanish version)
timeFrame: 12 months
measure: Changes in the Memorial Delirium Assessment Scale (MDAS scale Spanish version).
timeFrame: 12 months
Secondary outcomes:
measure: Change in functional capacity: Barthel Index (Spanish version)
timeFrame: 12 months
measure: Change in cognitive status: Informant Questionnaire on Cognitive Decline in the Elderly-short form (IQCODE-short form Spanish version)
timeFrame: 12 months
measure: Change in quality of life measured by the Spanish version of the EuroQol-5 Dimension (EQ-5D) questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra (HUN)
state: Navarra
Study officials:
affiliation: Hospital Universitario de Navarra (Pamplona, Spain)
name: Lucia Lozano Vicario, MD
role: PRINCIPAL_INVESTIGATOR
References: