OPTImized RESTing Environments in Rehabilitation

NCT04500951 | Terminated DMC

• 2 other identifiers: 801-10-72-32-18
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates whether an individually designed environment can support and improve the quality of daytime resting periods in in-hospital neurorehabilitation of patients suffering severe acquired brain injury. The effect of a individually optimized resting environment will be tested against a standard resting environment.

Conditions

Acquired Brain Injury

Keywords

Quality of rest; Daytime resting periods; Accelerometry; Electrocardiography

Outcome Measures

Primary Outcomes (8)

• Clinical evaluation of quality of rest

  A five option categorical scale going from "really bad"-"bad"-"good"-"really good "+ the option of "insufficient information for evaluation". Evaluation is performed by the patient responsible clinician at the end of each resting period. Duration of resting periods will be varying according to the needs of the patients for each resting period.

  Measurement represent the evaluated quality of rest for the duration of the resting period. Duration of resting periods will be varying according to the needs of the patients for each resting period. Estimated to be 30 minutes to 2½ hours.

• Actigraphic evaluation of motor rest ratio (MRR)

  Actigraphy will be measured during all resting periods. Epochs of 1 minute will be defined as active or inactive based on previous used limits. Motor rest ratio (MRR) defined as the proportions of minutes defined as resting out of all minutes recorded in each resting periods will be used to describe degree of motor rest

  Continuous data will be aggregated from the duration of each resting period. Duration of resting periods will be varying according to the needs of the patients for each resting period. Estimated to be 30 minutes to 2½ hours.

• Heart rate variability: LF band of the power spectrum of a 256 hz ECG recording

  The mean or median (Depending on distribution) low frequency power spectrum of all epochs for the duration of the resting periods will be used to characterize the balance in the autonomous nervous system.

  Continuous data will be aggregated from the duration of each resting period. Duration of resting periods will be varying according to the needs of the patients for each resting period. Estimated to be 30 minutes to 2½ hours.

• Heart rate variability: HF band of the power spectrum of a 256 hz ECG recording

  The mean or median (Depending on distribution) High frequency power spectrum of all epochs for the duration of the resting periods will be used to characterize the balance in the autonomous nervous system.

  Continuous data will be aggregated from the duration of each resting period. Duration of resting periods will be varying according to the needs of the patients for each resting period. Estimated to be 30 minutes to 2½ hours.

• Heart rate variability: LF/HF ratio of the power spectrum of a 256 hz ECG recording

  The mean or median (Depending on distribution) LF/HF ratio of all epochs for the duration of the resting periods will be used to characterize the balance in the autonomous nervous system.

  Continuous data will be aggregated from the duration of each resting period. Duration of resting periods will be varying according to the needs of the patients for each resting period. Estimated to be 30 minutes to 2½ hours.

• Heart rate variability: SDNN a time domain estimate of heart rate variability from of a 256 hz ECG recording

  The mean or median (Depending on distribution) SDNN of all epochs for the duration of the resting periods will be used to characterize the balance in the autonomous nervous system.

  Continuous data will be aggregated from the duration of each resting period. Duration of resting periods will be varying according to the needs of the patients for each resting period. Estimated to be 30 minutes to 2½ hours.

• Heart rate

  The mean/median heart rate of a 0.2 hz reported heart rate as measured by the monitor system Mindray nseries TM80.

  Continuous data will be aggregated from the duration of each resting period. Duration of resting periods will be varying according to the needs of the patients for each resting period. Estimated to be 30 minutes to 2½ hours.

• Respiratory rate

  The mean/median respiratory rate of a 0.2 hz reported respiratory rate as extrapolated by the monitor system Mindray nseries TM80 from a 256 hz ecg.

  Continuous data will be aggregated from the duration of each resting period. Duration of resting periods will be varying according to the needs of the patients for each resting period. Estimated to be 30 minutes to 2½ hours.

Study Arms (2)

Optimized resting environment

EXPERIMENTAL

The optimized resting environment will consist of the following complex intervention. * Technically assisted noise control in regards of alarms in the patient room * Visual signing reminding staff that the patient is not to be disturbed during rest * Individual optimization of room environment according to information received from relatives * Individual optimization of room environment and positioning according to systematized knowledge on best practice in the intervention ward including auditory and visual stimuli

Other: Optimized resting environment

Standard resting environment

OTHER

Standard resting environment, will consist of a basic positioning either reclined in bed or reclined in wheelchair according to regular procedures of the ward.

Other: Standard resting environment

Interventions

Optimized resting environment OTHER

Alarms from feeding pumps will be relayed to the nurse call system for all intervention periods. Alternatively meals will be timewise reorganized to not interfer with the intervention resting periods. Signs reminding staff not to disturb will be posted for all intervention periods. For each patient the close team of rehabilitation professionals will agree upon a guideline suggesting the optimal resting environment for the specific patient. The guideline wil be based on knowledge gathered from relatives on pre-injury preferences. Furthermore, the guideline will be developed based on a toolbox of possible intervention representing best practice. The toolbox has been designed according to the categories of the International Classification of Functioning. The intervention will designed individually for each patient.

Optimized resting environment

Standard resting environment OTHER

The control condition, standard resting environment, will consist of a basic positioning either reclined in bed or reclined in wheelchair according to regular procedures of the ward. Pressure ulcers and positioning believed to induce pain will be avoided.

Standard resting environment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe Acquired brain injury
• \>= 18 years
• Relatives/Surrogate can give informed consent
• Classified as being ≤ 7 on the level of cognitive functions scale (also known as Rancho Los Amigos Scale)

You may not qualify if:

• Admitted due to polyneuropathies e.g. Guillain-Barré
• Terminal illness
• Spinal lesions
• Expected stay \< 3 weeks
• Paroxysmal Sympathetic Hyperactivity

Sponsors & Collaborators

• University of Aarhus: lead
• Aalborg University: collaborator

Study Sites (1)

Regionshospitalet Hammel Neurocenter

Hammel, 8450, Denmark

Location

Related Links

• Aarhus University project description site

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jørgen F Nielsen, MD DMSc

  Hammel Neurorehabilitation Centre and University Research Clinic

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Model Details: A Randomized controlled time-series study. A Randomized controlled time-series study. Randomization to either SR or ORE for each of the 9 resting periods during a three-day recording session. A period of three days will allow collection of sufficient data. This will also allow the analysis to take the random effects of time and weekday into account.

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: August 6, 2020
• Study Start: May 20, 2020
• Primary Completion: April 28, 2021
• Study Completion: February 2, 2022
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)