Mobility and Activity Patterns in Hospitalised Severe Brain Injury

NCT05571462 | Active Not Recruiting

• 1 other identifier: H-22031667
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this observational study is to quantify physical activity patterns in patients with severe acquired brain injury admitted for in-hospital rehabilitation.

Conditions

Brain Injuries

Keywords

Exercise; Physical activity

Outcome Measures

Primary Outcomes (1)

• Early physical activity

  Activity data collected in the early phase will be the exposure variable. Amount of minutes patients are physically active.

  Continuous measure of physical activity during day three to ten of rehabilitation

Secondary Outcomes (8)

• Late physical activity

  Continuous measure of physical activity during day three to ten before discharge from rehabilitation

• Functional Independence Measure (discharge)

  Discharge from rehabilitation (3 months)

• Glasgow Coma Scale (GCS) (admission)

  Admission

• Comorbidities at admission

  Admission

• Early Functional Ability (EFA) score

  Admission

Other Outcomes (1)

• Complications during rehabilitation

  Rehabilitation period (3 months)

Study Arms (1)

Activity monitor group

No intervention will be applied. All patients will have activity monitors placed at the distal part of the femur and on the torso. Normal rehabilitation will be performed as usual.

Other: Activity monitor group

Interventions

Activity monitor group OTHER

No intervention will be applied. All included patients will be monitored with body-worn physical activity monitors during two periods.

Activity monitor group

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

Patients with acquired brain injury of any cause admitted for rehabilitation at the department will be recruited.

You may qualify if:

• years old

You may not qualify if:

• Planned discharge within two weeks
• Fractures of lower extremities, pelvis or spine prohibiting weight-bearing
• Amputation of lower extremities

Sponsors & Collaborators

• Christian Riberholt: lead
• SENS Innovation Aps: collaborator

Study Sites (1)

Department of Brain and Spinal Cord Injury

Glostrup Municipality, 2600, Denmark

Location

Related Publications (16)

• Okely AD, Kontsevaya A, Ng J, Abdeta C. 2020 WHO guidelines on physical activity and sedentary behavior. Sports Med Health Sci. 2021 May 14;3(2):115-118. doi: 10.1016/j.smhs.2021.05.001. eCollection 2021 Jun.

  PMID: 35782159 BACKGROUND

• Zeiler SR, Krakauer JW. The interaction between training and plasticity in the poststroke brain. Curr Opin Neurol. 2013 Dec;26(6):609-16. doi: 10.1097/WCO.0000000000000025.

  PMID: 24136129 BACKGROUND

• Nielsen JB, Willerslev-Olsen M, Christiansen L, Lundbye-Jensen J, Lorentzen J. Science-based neurorehabilitation: recommendations for neurorehabilitation from basic science. J Mot Behav. 2015;47(1):7-17. doi: 10.1080/00222895.2014.931273.

  PMID: 25575219 BACKGROUND

• Larsen RT, Wagner V, Korfitsen CB, Keller C, Juhl CB, Langberg H, Christensen J. Effectiveness of physical activity monitors in adults: systematic review and meta-analysis. BMJ. 2022 Jan 26;376:e068047. doi: 10.1136/bmj-2021-068047.

  PMID: 35082116 BACKGROUND

• Ferguson T, Olds T, Curtis R, Blake H, Crozier AJ, Dankiw K, Dumuid D, Kasai D, O'Connor E, Virgara R, Maher C. Effectiveness of wearable activity trackers to increase physical activity and improve health: a systematic review of systematic reviews and meta-analyses. Lancet Digit Health. 2022 Aug;4(8):e615-e626. doi: 10.1016/S2589-7500(22)00111-X.

  PMID: 35868813 BACKGROUND

• von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol. 2008 Apr;61(4):344-9. doi: 10.1016/j.jclinepi.2007.11.008.

  PMID: 18313558 BACKGROUND

• Vandenbroucke JP, von Elm E, Altman DG, Gotzsche PC, Mulrow CD, Pocock SJ, Poole C, Schlesselman JJ, Egger M; STROBE Initiative. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration. Epidemiology. 2007 Nov;18(6):805-35. doi: 10.1097/EDE.0b013e3181577511.

  PMID: 18049195 BACKGROUND

• Pedersen BS, Kristensen MT, Josefsen CO, Lykkegaard KL, Jonsson LR, Pedersen MM. Validation of Two Activity Monitors in Slow and Fast Walking Hospitalized Patients. Rehabil Res Pract. 2022 May 16;2022:9230081. doi: 10.1155/2022/9230081. eCollection 2022.

  PMID: 35615755 BACKGROUND

• Riberholt CG, Wagner V, Lindschou J, Gluud C, Mehlsen J, Moller K. Early head-up mobilisation versus standard care for patients with severe acquired brain injury: A systematic review with meta-analysis and Trial Sequential Analysis. PLoS One. 2020 Aug 13;15(8):e0237136. doi: 10.1371/journal.pone.0237136. eCollection 2020.

  PMID: 32790771 BACKGROUND

• Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.

  PMID: 26092476 BACKGROUND

• Kramer SF, Hung SH, Brodtmann A. The Impact of Physical Activity Before and After Stroke on Stroke Risk and Recovery: a Narrative Review. Curr Neurol Neurosci Rep. 2019 Apr 22;19(6):28. doi: 10.1007/s11910-019-0949-4.

  PMID: 31011851 BACKGROUND

• Fini NA, Bernhardt J, Said CM, Billinger SA. How to Address Physical Activity Participation After Stroke in Research and Clinical Practice. Stroke. 2021 Jun;52(6):e274-e277. doi: 10.1161/STROKEAHA.121.034557. Epub 2021 May 6. No abstract available.

  PMID: 33951930 BACKGROUND

• Adey-Wakeling Z, Jolliffe L, O'Shannessy E, Hunter P, Morarty J, Cameron ID, Liu E, Lannin NA. Activity, Participation, and Goal Awareness After Acquired Brain Injury: A Prospective Observational Study of Inpatient Rehabilitation. Ann Rehabil Med. 2021 Dec;45(6):413-421. doi: 10.5535/arm.21034. Epub 2021 Dec 31.

  PMID: 35000366 RESULT

• Norvang OP, Hokstad A, Taraldsen K, Tan X, Lydersen S, Indredavik B, Askim T. Correction to: Time spent lying, sitting, and upright during hospitalization after stroke: a prospective observation study. BMC Neurol. 2019 Jan 11;19(1):8. doi: 10.1186/s12883-018-1226-x.

  PMID: 30634934 RESULT

• Kjeldsen SS, Brodal L, Brunner I. Activity and rest in patients with severe acquired brain injury: an observational study. Disabil Rehabil. 2022 Jun;44(12):2744-2751. doi: 10.1080/09638288.2020.1844317. Epub 2020 Nov 8.

  PMID: 33161752 RESULT

• Wagner V, Gravesen P, Ghaziani E, Olsen MH, Riberholt CG. Mapping physical activity patterns in hospitalised patients with moderate to severe acquired brain injury - MAP-ABI: Protocol for an observational study. Heliyon. 2023 Nov 8;9(11):e21927. doi: 10.1016/j.heliyon.2023.e21927. eCollection 2023 Nov.

  PMID: 38034693 DERIVED

Related Links

• Wagner V, Gravesen P, Ghaziani E, Olsen MH, Riberholt CG. Mapping physical activity patterns in hospitalised patients with moderate to severe acquired brain injury - MAP-ABI: Protocol for an observational study. Heliyon. 2023 Nov 8;9(11):e21927.

MeSH Terms

Conditions

Brain Injuries; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Vibeke Wagner, MsC

  Rigshospitalet, Department of Brain and Spinal Cord Injury

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 7, 2022
• Study Start: November 3, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Two years after study completion. Data will be available for at least ten years.
• Access Criteria: Any researcher can make contact to primary investigator or sponsor with pre-planned project description.

Locations

DK (1)