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| Name | Class |
|---|---|
| SENS Innovation Aps | UNKNOWN |
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The purpose of this observational study is to quantify physical activity patterns in patients with severe acquired brain injury admitted for in-hospital rehabilitation.
Patients admitted for rehabilitation will be included for two periods of one-week monitorization of physical activity. The investigators will include all patients with moderate to severe brain injury.
This is an observational cross-sectional study including patients 18 years or above. Patients with conditions such as unstable fractures that restricts mobilisation are excluded. Physical activity is measured continuously during rehabilitation at two separate seven-day periods using a body-worn activity tracker. The first period will be initiated in the early phase of rehabilitation (3 days after admission) and the second at the late phase (10 days before discharge).
Baseline variables considered predictors, confounders or modifiers for physical activity will be collected along with registration of variables during the measurement periods and functional outcome variables at discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activity monitor group | Other | No intervention will be applied. All included patients will be monitored with body-worn physical activity monitors during two periods. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Late 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 before discharge from rehabilitation |
| Functional Independence Measure (discharge) |
| Measure | Description | Time Frame |
|---|---|---|
| Complications during rehabilitation | Registration of the number of complications during rehabilitation stay at hospital (e.g. pneumonia, unrinary infection, hydrocephalus etc). Predefined in protocol. | Rehabilitation period (3 months) |
Inclusion Criteria:
Exclusion Criteria:
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Patients with acquired brain injury of any cause admitted for rehabilitation at the department will be recruited.
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| Name | Affiliation | Role |
|---|---|---|
| Vibeke Wagner, MsC | Rigshospitalet, Department of Brain and Spinal Cord Injury | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Brain and Spinal Cord Injury | Glostrup Municipality | 2600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35782159 | Background | 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. | |
| 24136129 | 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. |
| Label | URL |
|---|---|
| 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. | View source |
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Data that are truly anonymised will be uploaded to Zenodo after the publication of the study. Data that we are not able to truly anonymise will be available upon reasonable request.
Two years after study completion. Data will be available for at least ten years.
Any researcher can make contact to primary investigator or sponsor with pre-planned project description.
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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Functional scale evaluating independence from a score of 18 (worst) to 126 (best) |
| Discharge from rehabilitation (3 months) |
| Glasgow Coma Scale (GCS) (admission) | Coma scale with score between 3 (worst) to 15 (best) | Admission |
| Comorbidities at admission | Number of comorbidities | Admission |
| Early Functional Ability (EFA) score | Early signs of functional ability. Score between 20 (worst) and 100 (best) | Admission |
| Ranchos Los Amigos Score | Level of cognitive function. Score between 1 (worst) and 8 (best) | Admission |
| Length of stay at intensive care unit | Number of days at intensive care unit before admission to rehabilitation unit | Retrospectively recorded at admission to the rehabilitation department |
| Agitated Behaviour Scale (ABS) | Days with ABS above 22. Dichotomised outcome with scores above 22 indicating agitated behaviour. | Day three to ten of rehabilitation |
| 25575219 | 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. |
| 35082116 | 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. |
| 35868813 | 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. |
| 18313558 | 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. |
| 18049195 | 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. |
| 35615755 | 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. |
| 32790771 | 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. |
| 26092476 | 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. |
| 31011851 | 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. |
| 33951930 | 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. |
| 35000366 | Result | 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. |
| 30634934 | 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. |
| 33161752 | 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. |
| 38034693 | Derived | 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. |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D001519 | Behavior |