Physical Activity on Heart Rate Variability in Patients With Severe Acquired Brain Injury

NCT03328221 | Completed DMC

• 1 other identifier: RH-2017-288, I-Suite: 05851
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to explore autonomic cardiovascular regulation, through measures of heart rate variability (HRV), during different passive and active activities in patients with severe acquired brain injury and a low conscious state. Data from active rehabilitation will be compared with passive periods of rest as well as nightly variance during a continuous 5-day period.

Conditions

Acquired Brain Injury; Consciousness, Level Altered

Keywords

Heart rate variability; Observational study; Physical activity; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Low frequency (LF) spectral analysis

  LF (0.05-0.15 Hz) during activity (T-exercise), rest (T-rest) and sleep (T-night)

  5 days of continuous measurements

Secondary Outcomes (3)

• High frequency (HF) spectral analysis

  5 days of continuous measurements

• LF/HF ratio

  5 days of continuous measurements

• SDRR

  5 days of continuous measurements

Eligibility Criteria

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

Study Population

Adult patients admitted at Department of Neurorehabilitation/TBI Unit, Rigshospitalet, Denmark, with a low conscious state (vegetative or minimally conscious state) 40 days removed from injury.

You may qualify if:

• Admitted at Department of Neurorehabilitation/TBI Unit, Rigshospitalet, Denmark
• Low conscious state (vegetative or minimally as determined by Glasgow Recovery Scale - Revised (CRS-R))

You may not qualify if:

• Known heart disease prior to brain injury
• Not possible to obtain informed consent
• Patients fiddling with or removing other monitoring equipment

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

at Department of Neurorehabilitation/TBI Unit, Rigshospitalet, Denmark

Copenhagen, 2650, Denmark

Location

Related Publications (8)

• Faul M, Coronado V. Epidemiology of traumatic brain injury. Handb Clin Neurol. 2015;127:3-13. doi: 10.1016/B978-0-444-52892-6.00001-5.

  PMID: 25702206 BACKGROUND

• McLafferty FS, Barmparas G, Ortega A, Roberts P, Ko A, Harada M, Nuno M, Black KL, Ley EJ. Predictors of improved functional outcome following inpatient rehabilitation for patients with traumatic brain injury. NeuroRehabilitation. 2016 Jul 15;39(3):423-30. doi: 10.3233/NRE-161373.

  PMID: 27589512 BACKGROUND

• Riberholt CG, Olesen ND, Thing M, Juhl CB, Mehlsen J, Petersen TH. Impaired Cerebral Autoregulation during Head Up Tilt in Patients with Severe Brain Injury. PLoS One. 2016 May 11;11(5):e0154831. doi: 10.1371/journal.pone.0154831. eCollection 2016.

  PMID: 27168188 BACKGROUND

• Vistisen ST, Hansen TK, Jensen J, Nielsen JF, Fleischer J. Heart rate variability in neurorehabilitation patients with severe acquired brain injury. Brain Inj. 2014;28(2):196-202. doi: 10.3109/02699052.2013.860477. Epub 2013 Dec 2.

  PMID: 24295072 BACKGROUND

• Sequeira H, Viltart O, Ba-M'Hamed S, Poulain P. Cortical control of somato-cardiovascular integration: neuroanatomical studies. Brain Res Bull. 2000 Sep 1;53(1):87-93. doi: 10.1016/s0361-9230(00)00312-9.

  PMID: 11033212 BACKGROUND

• Hallman DM, Holtermann A, Sogaard K, Krustrup P, Kristiansen J, Korshoj M. Effect of an aerobic exercise intervention on cardiac autonomic regulation: A worksite RCT among cleaners. Physiol Behav. 2017 Feb 1;169:90-97. doi: 10.1016/j.physbeh.2016.11.031. Epub 2016 Nov 24.

  PMID: 27889332 BACKGROUND

• van de Vooren H, Gademan MG, Swenne CA, TenVoorde BJ, Schalij MJ, Van der Wall EE. Baroreflex sensitivity, blood pressure buffering, and resonance: what are the links? Computer simulation of healthy subjects and heart failure patients. J Appl Physiol (1985). 2007 Apr;102(4):1348-56. doi: 10.1152/japplphysiol.00158.2006. Epub 2006 Dec 21.

  PMID: 17185500 BACKGROUND

• Henden PL, Sondergaard S, Rydenhag B, Reinsfelt B, Ricksten SE, Aneman A. Can baroreflex sensitivity and heart rate variability predict late neurological outcome in patients with traumatic brain injury? J Neurosurg Anesthesiol. 2014 Jan;26(1):50-9. doi: 10.1097/ANA.0b013e3182a47b62.

  PMID: 24064714 BACKGROUND

MeSH Terms

Conditions

Brain Injuries; Consciousness Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Behavior

Study Officials

• Christian Riberholt

  Department of Neurorehabilitation, TBI Unit

  PRINCIPAL INVESTIGATOR

• Ingrid Poulsen

  Department of Neurorehabilitation, TBI Unit

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of research department RUBRIC

Study Record Dates

• First Submitted: October 28, 2017
• First Posted: November 1, 2017
• Study Start: September 1, 2017
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: March 9, 2021

Record last verified: 2021-03

Locations

DK (1)