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

Primary Purpose

Delirium

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Multicomponent exercise training programme
Sponsored by
Fundacion Miguel Servet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delirium focused on measuring physical exercise, multicomponent intervention, geriatric acute unit, older adults

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitario de Navarra (HUN)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Physical exercise

Without physical exercise

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Change in functional capacity: Barthel Index (Spanish version)
The change in Barthel Index measured at baseline and follow-up (a measure of Basic Activities of Daily Living). This index ranges from 0 worst to 100 best.
Change in cognitive status: Informant Questionnaire on Cognitive Decline in the Elderly-short form (IQCODE-short form Spanish version)
The change in IQCODE-short form will be measured at baseline and follow-up. This test has 16 questions. Each question is scored from 1 (much improved) to 5 (much worse). For the Short IQCODE, a cut-off point (average score) of 3.31/3.38 achieves a balance of sensitivity and specificity of cognitive impairment.
Change in quality of life measured by the Spanish version of the EuroQol-5 Dimension (EQ-5D) questionnaire
The change in EuroQol-5 Dimension (EQ-5D) questionnaire measured at baseline and follow-up. The EQ records the respondent´s overall current health on a vertical visual analogue scale, where the endpoints are labelled "The best health you can imagine" and "The worst health you can imagine". Minimum 0 Maximum 100 Higher scores mean a better outcome

Full Information

First Posted
June 14, 2022
Last Updated
June 28, 2022
Sponsor
Fundacion Miguel Servet
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1. Study Identification

Unique Protocol Identification Number
NCT05442892
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2022 (Actual)
Primary Completion Date
December 29, 2022 (Anticipated)
Study Completion Date
February 27, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion Miguel Servet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
physical exercise, multicomponent intervention, geriatric acute unit, older adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Without physical exercise
Arm Type
No Intervention
Arm Description
Participants randomly assigned to the usual care group will receive normal hospital care, which includes physical rehabilitation when needed
Intervention Type
Procedure
Intervention Name(s)
Multicomponent exercise training programme
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in the 4 'A's Test (4AT scale Spanish version)
Description
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.
Time Frame
12 months
Title
Changes in the Memorial Delirium Assessment Scale (MDAS scale Spanish version).
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in functional capacity: Barthel Index (Spanish version)
Description
The change in Barthel Index measured at baseline and follow-up (a measure of Basic Activities of Daily Living). This index ranges from 0 worst to 100 best.
Time Frame
12 months
Title
Change in cognitive status: Informant Questionnaire on Cognitive Decline in the Elderly-short form (IQCODE-short form Spanish version)
Description
The change in IQCODE-short form will be measured at baseline and follow-up. This test has 16 questions. Each question is scored from 1 (much improved) to 5 (much worse). For the Short IQCODE, a cut-off point (average score) of 3.31/3.38 achieves a balance of sensitivity and specificity of cognitive impairment.
Time Frame
12 months
Title
Change in quality of life measured by the Spanish version of the EuroQol-5 Dimension (EQ-5D) questionnaire
Description
The change in EuroQol-5 Dimension (EQ-5D) questionnaire measured at baseline and follow-up. The EQ records the respondent´s overall current health on a vertical visual analogue scale, where the endpoints are labelled "The best health you can imagine" and "The worst health you can imagine". Minimum 0 Maximum 100 Higher scores mean a better outcome
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolás Martínez Velilla
Phone
34 848 42 22 22
Ext
22287
Email
nicolas.martinez.velilla@navarra.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucia Lozano Vicario, MD
Organizational Affiliation
Hospital Universitario de Navarra (Pamplona, Spain)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario de Navarra (HUN)
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolás Martínez-Velilla, PhD
Phone
T +(34) 848 42 22 87
Email
nicolas.martinez.velilla@navarra.es

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data obtained through this study may be provided to qualified researchers with academic interest in delirium and frailty. Data or samples shared will be coded.
IPD Sharing 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.
IPD Sharing 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).

Learn more about this trial

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

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