NCT04500951

OPTImized RESTing Environments in Rehabilitation

Evaluation and Improvement of Rest Activity Cycles and Rest Quality in Patients With Severe Acquired Brain Injury

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Aim: The aim is to identify differences in quality of rest as reflected by clinical evaluation, pulse rate, motor activity and autonomic balance between the optimized resting environment (ORE) and the standard resting environment (SR). Method: 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. Outcome measures will be differences in mean heart rate during daytime resting periods, aggregated measures of heart rate variability and proportion of resting minutes according to accelerometry.

Conditions

• Acquired Brain Injury

Interventions

Type	Name	Description
OTHER	Optimized resting environment	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.
OTHER	Standard resting environment	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.

Timeline

• Start date: 2020-05-20
• Primary completion: 2021-04-28
• Completion: 2022-02-02
• First posted: 2020-08-06
• Last updated: 2022-05-23

Locations

1 site across 1 country: Denmark