Use of Near Infrared Spectroscopy (NIRS) as a Biomarker of Delirium in Hospitalized Older Adults Doing Physical Exercise

NCT05442892 | Completed DMC

• 1 other identifier: DelNIRS
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Keywords

physical exercise; multicomponent intervention; geriatric acute unit; older adults

Outcome Measures

Primary Outcomes (2)

• Changes in the 4 'A's Test (4AT scale Spanish version)

  The change in the 4 'A's Test (4AT scale) measured at baseline and follow-up. The 4AT is designed to be used as a delirium detection tool in general clinical settings.The 4AT has 4 parameters: Alertness, Abbreviated mental test-4 (AMT4), Attention (months backwards test) and Acute change or fluctuating course. The score range is 0-12, with scores of 4 or more suggesting possible delirium. Scores of 1-3 suggest possible cognitive impairment.

  12 months

• Changes in the Memorial Delirium Assessment Scale (MDAS scale Spanish version).

  The change in Memorial Delirium Assessment Scale (MDAS scale Spanish version) measured at baseline and follow-up. MDAS scale was designed to diagnose delirium as well as classify delirium severity. The instrument reflects delirium diagnostic criteria from DSM. It has 10 severity items rated 0 to 3 points for a maximum total score of 30 points, with higher scores representing more severe delirium.

  12 months

Secondary Outcomes (3)

• Change in functional capacity: Barthel Index (Spanish version)

  12 months

• Change in cognitive status: Informant Questionnaire on Cognitive Decline in the Elderly-short form (IQCODE-short form Spanish version)

  12 months

• Change in quality of life measured by the Spanish version of the EuroQol-5 Dimension (EQ-5D) questionnaire

  12 months

Study Arms (2)

Physical exercise

EXPERIMENTAL

The intervention will consist of a multicomponent exercise training programme, which will be composed of supervised progressive resistance exercise training, balance-training, strength-training and walking for 4 consecutive days. During the training period, patients will be trained in 30 min sessions daily.

Procedure: Multicomponent exercise training programme

Without physical exercise

NO INTERVENTION

Participants randomly assigned to the usual care group will receive normal hospital care, which includes physical rehabilitation when needed

Interventions

Multicomponent exercise training programme PROCEDURE

The supervised multicomponent exercise training programme will be comprised of upper and lower body strengthening exercises, tailored to the individuals functional capacity, using weight machines and aiming for 2-3 sets of 8-10 repetitions at an intensity of 30-60% of 1RM (Matrix, Johnson Health Tech, Ibérica, S.L. Torrejón de Arroz, Madrid, Spain) combined with balance and gait retraining exercises that progressed in difficulty and functional exercises such as rises from a chair.

Physical exercise

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacion Miguel Servet: lead

Study Sites (1)

Hospital Universitario de Navarra (HUN)

Pamplona, Navarre, 31008, Spain

Location

Related Publications (1)

• Lozano-Vicario L, Zambom-Ferraresi F, Zambom-Ferraresi F, de la Casa-Marin A, Ollo-Martinez I, Saez de Asteasu ML, Cedeno-Veloz BA, Fernandez-Irigoyen J, Santamaria E, Romero-Ortuno R, Izquierdo M, Martinez-Velilla N. Effectiveness of a multicomponent exercise training program for the management of delirium in hospitalized older adults using near-infrared spectroscopy as a biomarker of brain perfusion: Study protocol for a randomized controlled trial. Front Aging Neurosci. 2022 Dec 15;14:1013631. doi: 10.3389/fnagi.2022.1013631. eCollection 2022.

  PMID: 36589545 DERIVED

MeSH Terms

Conditions

Delirium; Motor Activity

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Behavior

Study Officials

• Lucia Lozano Vicario, MD

  Hospital Universitario de Navarra (Pamplona, Spain)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: July 5, 2022
• Study Start: February 1, 2022
• Primary Completion: May 31, 2023
• Study Completion: August 31, 2023
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

Locations

ES (1)