Early rehabilitation in sepsis: a prospective randomised controlled trial investigating functional and physiological outcomes The i-PERFORM Trial(Protocol Article)

Kayambu, Geetha; Boots, Robert J; Paratz, Jennifer D

doi:10.1186/1471-2253-11-21

Cited by 37Intensive Care Unit Cognitive DisordersSepsis Diagnosis and TreatmentClinical Nutrition and Gastroenterology

Early rehabilitation in sepsis: a prospective randomised controlled trial investigating functional and physiological outcomes The i-PERFORM Trial(Protocol Article)

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Kayambu, Geetha, Boots, Robert J, Paratz, Jennifer D·2011·BMC Anesthesiology

DOI 10.1186/1471-2253-11-21PMC PMC3306201

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Abstract

BACKGROUND: Patients with sepsis syndromes in comparison to general intensive care patients can have worse outcomes for physical function, quality of life and survival. Early intensive care rehabilitation can improve the outcome in general Intensive Care Unit (ICU) patients, however no investigations have specifically looked at patients with sepsis syndromes. The 'i-PERFORM Trial' will investigate if early targeted rehabilitation is both safe and effective in patients with sepsis syndromes admitted to ICU. METHODS/DESIGN: A single-centred blinded randomized controlled trial will be conducted in Brisbane, Australia. Participants (n = 252) will include those ≥ 18 years, mechanically ventilated for ≥ 48 hours and diagnosed with a sepsis syndrome. Participants will be randomised to an intervention arm which will undergo an early targeted rehabilitation program according to the level of arousal, strength and cardiovascular stability and a control group which will receive normal care.The primary outcome measures will be physical function tests on discharge from ICU (The Acute Care Index of Function and The Physical Function ICU Test). Health-related quality of life will be measured using the Short Form-36 and the psychological component will be tested using The Hospital Anxiety and Depression Scale. Secondary measures will include inflammatory biomarkers; Interleukin-6, Interleukin-10 and Tumour Necrosis Factor-α, peripheral blood mitochondrial DNA content and lactate, fat free muscle mass, tissue oxygenation and microcirculatory flow. DISCUSSION: The 'i-PERFORM Trial' will determine whether early rehabilitation for patients with sepsis is effective at improving patient outcomes with functional and physiological parameters reflecting long and short-term effects of early exercise and the safety in its application in critical illness. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12610000808044.

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Muscle electrical stimulation may be an effective therapy to help alleviate muscle loss in individuals who cannot tolerate exercise or very high protein/amino acid supplementation.
“In these situations, muscle electrical stimulation may be an effective therapy to help alleviate muscle loss.186e188”
From Evidence-Based Recommendations for Optimal Dietary Protein Intake in Older People: A Position Paper From the PROT-AGE Study Group (2013) · cites this paper as [188]
The Methods/Design intervention table (page not specified) includes electrical muscle stimulation for sedated patients, who may be unable to exercise actively, and the secondary outcomes include muscle mass. But this is a trial protocol: it does not show that stimulation alleviates muscle loss, nor does it address people unable to tolerate high protein or amino acid supplementation. (LLM, conf=0.84)
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Evidence-Based Recommendations for Optimal Dietary Protein Intake in Older People: A Position Paper From the PROT-AGE Study Group
Bauer, J., Biolo, G., Cederholm, T., Cesari, M., Cruz-Jentoft, A. J., Morley, J. E., Phillips, S., Sieber, C., Stehle, P., Teta, D., et al. (2013) · Journal of the American Medical Directors Association · doi:10.1016/j.jamda.2013.05.021 · Cited by 2,553 · see citing works
Early physical rehabilitation in intensive care patients with sepsis syndromes: a pilot randomised controlled trial
Kayambu, G., Boots, R. J., & Paratz, J. D. (2015) · Intensive Care Medicine · doi:10.1007/s00134-015-3763-8 · Cited by 233 · see citing works
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Clinical review: Early patient mobilization in the ICU
Hodgson, C. L., Berney, S. C., Harrold, M., Saxena, M. K., & Bellomo, R. (2012) · Critical Care · doi:10.1186/cc11820 · Cited by 225 · see citing works
Association of Postdischarge Rehabilitation with Mortality in Intensive Care Unit Survivors of Sepsis
Chao, P.-W., Shih, C.-J., Lee, Y.-J., Tseng, C.-M., Kuo, S., Shih, Y.-N., Chou, K., Tarng, D., Li, S., Ou, S., et al. (2014) · American Journal of Respiratory and Critical Care Medicine · doi:10.1164/rccm.201406-1170oc · Cited by 121 · see citing works
Assessment and predictors of physical functioning post-hospital discharge in survivors of critical illness
Solverson, K., Grant, C. J., & Doig, C. J. (2016) · Annals of Intensive Care · doi:10.1186/s13613-016-0187-8 · Cited by 58 · see citing works
What factors affect implementation of early rehabilitation into intensive care unit practice? A qualitative study with clinicians
Parry, S. M., Remedios, L. J., Denehy, L., Knight, L. D., Beach, L. J., Rollinson, T. C., Berney, S. C., Puthucheary, Z., Morris, P. E., & Granger, C. L. (2016) · Journal of Critical Care · doi:10.1016/j.jcrc.2016.11.005 · Cited by 56 · see citing works
Intensive care unit nurses' knowledge, attitudes, and perceived barriers regarding early mobilization of patients
Wang, J., Xiao, Q., Zhang, C., Jia, Y., & Shi, C. (2020) · Nursing in Critical Care · doi:10.1111/nicc.12507 · Cited by 42 · see citing works
Prise en charge de la mobilisation précoce en réanimation, chez l’adulte et l’enfant (électrostimulation incluse)
Roeseler, J., Sottiaux, T. M., Lemiale, V., Lesny, M., Beduneau, G., Bialais, É., Bradaï, N., Castelain, V., Dinomais, M., Dousse, N., et al. (2013) · Réanimation · doi:10.1007/s13546-013-0658-y · Cited by 38 · see citing works
Trajectory of Cognitive Decline After Sepsis
Wang, H. E., Kabeto, M., Gray, M., Wadley, V. G., Muntner, P., Judd, S. E., Safford, M. M., Kempker, J. A., & Levine, D. A. (2021) · Critical Care Medicine · doi:10.1097/ccm.0000000000004897 · Cited by 35 · see citing works
Return to work after hospitalization for sepsis: a nationwide, registry-based cohort study
Skei, N. V., Moe, K., Nilsen, T. I. L., Aasdahl, L., Prescott, H. C., Damås, J. K., & Gustad, L. T. (2023) · Critical Care · doi:10.1186/s13054-023-04737-7 · Cited by 31 · see citing works
Early Mobilization in the Intensive Care Unit to Improve Long-Term Recovery
Paton, M., Lane, R., & Hodgson, C. L. (2018) · Critical Care Clinics · doi:10.1016/j.ccc.2018.06.005 · Cited by 30 · see citing works
IMPOSE (IMProving Outcomes after Sepsis)—the effect of a multidisciplinary follow-up service on health-related quality of life in patients postsepsis syndromes—a double-blinded randomised controlled trial: protocol
Paratz, J. D., Kenardy, J., Mitchell, G., Comans, T., Coyer, F., Thomas, P., Singh, S., Luparia, L., & Boots, R. J. (2014) · BMJ Open · doi:10.1136/bmjopen-2014-004966 · Cited by 29 · see citing works
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Improving physical function during and after critical care
Hough, C. L. (2013) · Current Opinion in Critical Care · doi:10.1097/mcc.0b013e328364d7ef · Cited by 27 · see citing works
Effects of Early Exercise Rehabilitation on Functional Recovery in Patients with Severe Sepsis
Ahn, J. Y., Song, J. E., Ann, H. W., Jeon, Y., Ahn, M. Y., Jung, I. Y., Kim, M. H., Jeong, W., Jeong, S. J., Ku, N. S., et al. (2018) · Yonsei Medical Journal · doi:10.3349/ymj.2018.59.7.843 · Cited by 25 · see citing works
Feasibility of Exercise Testing in Patients Who Are Critically Ill: A Prospective, Observational Multicenter Study
Sommers, J., Klooster, E., Zoethout, S. B., van den Oever, H. L. A., Nollet, F., Tepaske, R., Horn, J., Engelbert, R., & van der Schaaf, M. (2018) · Archives of Physical Medicine and Rehabilitation · doi:10.1016/j.apmr.2018.07.430 · Cited by 23 · see citing works
Mobilization in severe sepsis: An integrative review
Govindan, S., Iwashyna, T. J., Odden, A., Flanders, S. A., & Chopra, V. (2014) · Journal of Hospital Medicine · doi:10.1002/jhm.2281 · Cited by 18 · see citing works
Evaluating Physical Functioning in Survivors of Critical Illness: Development of a New Continuum Measure for Acute Care*
Parry, S. M., Knight, L. D., Baldwin, C. E., Sani, D., Kayambu, G., Silva, V. M. D., Phongpagdi, P., Clarke, S., Puthucheary, Z., Morris, P. E., et al. (2020) · Critical Care Medicine · doi:10.1097/ccm.0000000000004499 · Cited by 17 · see citing works
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Septic predictor index: A novel platform to identify thermally injured patients susceptible to sepsis
Chen, P., Stanojcic, M., & Jeschke, M. G. (2017) · Surgery · doi:10.1016/j.surg.2017.08.010 · Cited by 15 · see citing works
Roles and Molecular Mechanisms of Physical Exercise in Sepsis Treatment
Wu, Y., Guo, X., Peng, Y., Fang, Z., & Zhang, X. (2022) · Frontiers in Physiology · doi:10.3389/fphys.2022.879430 · Cited by 12 · see citing works
Intensive Care Unit-Acquired Weakness
Harvey, N. R., & Stanton, M. P. (2017) · Professional Case Management · doi:10.1097/ncm.0000000000000192 · Cited by 9 · see citing works
Entraînement en force des muscles inspirateurs du patient ventilé — de la dysfonction diaphragmatique au sevrage de la ventilation mécanique
Bonnevie, T. (2013) · Réanimation · doi:10.1007/s13546-013-0694-7 · Cited by 8 · see citing works
Efeitos da mobilização precoce em pacientes com sepse internados na unidade de terapia intensiva
de OLIVEIRA, D. C. A. (2019) · doi:10.14393/ufu.di.2019.2292 · Cited by 8 · see citing works
Preventive effects of kilohertz frequency electrical stimulation on sepsis-induced muscle atrophy.
Tanaka, M., Tanaka, K., Tategaki, J., & Fujino, H. (2016) · PubMed Central · Cited by 6 · see citing works
Improving physical function of patients following intensive care unit admission (EMPRESS): protocol of a randomised controlled feasibility trial
Cusack, R., Bates, A. S., Mitchell, K., van Willigen, Z., Denehy, L., Hart, N., Dushianthan, A., Reading, I., Chorozoglou, M., Sturmey, G., et al. (2022) · BMJ Open · doi:10.1136/bmjopen-2021-055285 · Cited by 3 · see citing works
Patient Characteristics and Acute PT and OT Utilization During the Initial Surge of COVID-19
Myszenski, A., Bello, R., Melican, C., & Pfitzenmaier, N. (2021) · Journal of Acute Care Physical Therapy · doi:10.1097/jat.0000000000000163 · Cited by 2 · see citing works
Impacto do nível de atividade física na funcionalidade de pacientes na unidade de terapia intensiva
Nogueira, D. S. S. (2016) · Digital Library of Theses and Dissertations (Universidade de São Paulo) · doi:10.11606/d.5.2016.tde-06092016-162425 · Cited by 1 · see citing works
Physical Function in Critical Care Tool Bridges the Waters of ICU and Post Acute Care Physical Functioning Assessments*
Rathore, S. S., & George, P. (2020) · Critical Care Medicine · doi:10.1097/ccm.0000000000004537 · Cited by 1 · see citing works
Activité physique et nutrition en réanimation
Lemaire, M., & Preiser, J. (2014) · Nutrition Clinique et Métabolisme · doi:10.1016/j.nupar.2014.10.009
Associação entre alterações musculares e perda funcional de pacientes críticos após a internação na unidade de terapia intensiva: estudo observacional, longitudinal
Lamano, M. Z. (2019) · Digital Library of Theses and Dissertations (Universidade de São Paulo) · doi:10.11606/d.5.2019.tde-14022019-093439
Barriers and Facilitators to Early Physical Rehabilitation in Mechanically Ventilated Patients
Goddard, S. L. (2017) · TSpace (University of Toronto)
Exercise interventions with critically ill patients in an Australian tertiary intensive care unit
Nickels, M. (2020) · Queensland University of Technology · doi:10.5204/thesis.eprints.206174
Progress in Rehabilitation Treatments for Sepsis Patients in ICU
Wang, L., & Zhang, Z. (2022) · Journal of Human Health Research · doi:10.14302/issn.2576-9383.jhhr-22-4146
Actualización en rehabilitación
Gutiérrez, T. (2018) · Revista Hospital Clínico Universidad de Chile · doi:10.5354/2735-7996.2018.70374
Mesure instantanée, aisée et non invasive de la pression artérielle, de la fréquence cardiaque et du débit cardiaque: application en kinésithérapie
Lamotte, M. (2012) · Réanimation · doi:10.1007/s13546-012-0521-6
Additional file 1 of Return to work after hospitalization for sepsis: a nationwide, registry-based cohort study
Skei, N. V., Moe, K., Nilsen, T. I. L., Aasdahl, L., Prescott, H. C., Damås, J. K., & Gustad, L. T. (2023) · Figshare · doi:10.6084/m9.figshare.24571885
Beyond muscle weakness: pathogenesis of sepsis-induced myopathy and its management
Liu, Y., Zhao, X., Xu, Z., Liu, Q., & Wang, Y.-C. (2026) · Open Medicine · doi:10.1515/med-2025-1342

Early physical rehabilitation in intensive care patients with sepsis syndromes: a pilot randomised controlled trial
Kayambu, G., Boots, R. J., & Paratz, J. D. (2015) · Intensive Care Medicine · doi:10.1007/s00134-015-3763-8 · Cited by 233 · see citing works
Self-citation
Early physical rehabilitation in intensive care patients with sepsis syndromes—a randomised controlled trial
Kayambu, G., Boots, R. J., & Paratz, J. D. (2015) · Physiotherapy · doi:10.1016/j.physio.2015.03.3597 · Cited by 4 · see citing works
Self-citation
Improving outcomes in critical illness with early physical rehabilitation
Kayambu, G. (2015) · The University of Queensland · doi:10.14264/uql.2015.1042
Self-citation
Rehabilitation for patients with sepsis: A systematic review and meta-analysis
Taito, S., Taito, M., Banno, M., Tsujimoto, H., Kataoka, Y., & Tsujimoto, Y. (2018) · PLoS ONE · doi:10.1371/journal.pone.0201292 · Cited by 27 · see citing works
Effects of Early Exercise Rehabilitation on Functional Recovery in Patients with Severe Sepsis
Ahn, J. Y., Song, J. E., Ann, H. W., Jeon, Y., Ahn, M. Y., Jung, I. Y., Kim, M. H., Jeong, W., Jeong, S. J., Ku, N. S., et al. (2018) · Yonsei Medical Journal · doi:10.3349/ymj.2018.59.7.843 · Cited by 25 · see citing works

Authors: Kayambu, G., Boots, R. J., & Paratz, J. D.
Affiliations: The University of Queensland (AU)
Corresponding author: Kayambu, Geetha
ORCID: Boots, Robert J
Paratz, Jennifer D
Venue: BMC Anesthesiology
Publisher: Springer Science and Business Media LLC
Published: 2011-10-31
Volume: 11
Issue: 1
Pages: 21-21
ISSN: 1471-2253 (ISSN-L)
DOI: 10.1186/1471-2253-11-21
PMC: PMC3306201
OpenAlex: W1966472590
Cited by: 37
References: 82
Citations by year: 2026: 1 · 2023: 3 · 2022: 3 · 2021: 2 · 2020: 4 · 2019: 2 · 2018: 4 · 2017: 3 · 2016: 4 · 2015: 1 · 2014: 4 · 2013: 4 · 2012: 2
FWCI: 2.59
Type: journal article
Language: en
Open access: gold
doi.org
Licence: cc-by
creativecommons.org/licenses/by/2.0 (tdm)
Locations: BMC Anesthesiology (publishedVersion, cc-by)
PubMed Central (publishedVersion, cc-by)
PubMed (publishedVersion)
DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
Griffith Research Online (submittedVersion, cc-by)
Funders: University of Queensland
Topics: Health Sciences › Medicine › Critical Care and Intensive Care Medicine › Intensive Care Unit Cognitive Disorders
Health Sciences › Medicine › Epidemiology › Sepsis Diagnosis and Treatment
Health Sciences › Nursing › Nutrition and Dietetics › Clinical Nutrition and Gastroenterology
Keywords: sepsis, early rehabilitation, intensive care unit, mechanical ventilation, physical function, health-related quality of life, anxiety and depression, inflammatory markers, interleukin-6, IL-10, TNF-α, mitochondrial DNA, lactate, tissue oxygenation, microvascular blood flow

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