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Published in: Trials 1/2019

Open Access 01-12-2019 | ICU-Acquired Weakness | Study protocol

Repetitive vascular occlusion stimulus (RVOS) versus standard care to prevent muscle wasting in critically ill patients (ROSProx):a study protocol for a pilot randomised controlled trial

Authors: Ismita Chhetri, Julie E. A. Hunt, Jeewaka R. Mendis, Stephen D. Patterson, Zudin A. Puthucheary, Hugh E. Montgomery, Benedict C. Creagh-Brown

Published in: Trials | Issue 1/2019

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Abstract

Background

Forty per cent of critically ill patients are affected by intensive care unit-acquired weakness (ICU-AW), to which skeletal muscle wasting makes a substantial contribution. This can impair outcomes in hospital, and can cause long-term physical disability after hospital discharge. No effective mitigating strategies have yet been identified.
Application of a repetitive vascular occlusion stimulus (RVOS) a limb pressure cuff inducing brief repeated cycles of ischaemia and reperfusion, can limit disuse muscle atrophy in both healthy controls and bed-bound patients recovering from knee surgery. We wish to determine whether RVOS might be effective in mitigating against muscle wasting in the ICU. Given that RVOS can also improve vascular function in healthy controls, we also wish to assess such effects in the critically ill. We here describe a pilot study to assess whether RVOS application is safe, tolerable, feasible and acceptable for ICU patients.

Methods

This is a randomised interventional feasibility trial. Thirty-two ventilated adult ICU patients with multiorgan failure will be recruited within 48 h of admission and randomised to either the intervention arm or the control arm. Intervention participants will receive RVOS twice daily (except only once on day 1) for up to 10 days or until ICU discharge.
Serious adverse events and tolerability (pain score) will be recorded; feasibility of trial procedures will be assessed against pre-specified criteria and acceptability by semi-structured interview. Together with vascular function, muscle mass and quality will be assessed using ultrasound and measures of physical function at baseline, on days 6 and 11 of study enrolment, and at ICU and hospital discharge. Blood and urine biomarkers of muscle metabolism, vascular function, inflammation and DNA damage/repair mechanism will also be analysed. The Health questionnaire will be completed 3 months after hospital discharge.

Discussion

If this study demonstrates feasibility, the derived data will be used to inform the design (and sample size) of an appropriately-powered prospective trial to clarify whether RVOS can help preserve muscle mass/improve vascular function in critically ill patients.

Trial registration

ISRCTN Registry, ISRCTN44340629. Registered on 26 October 2017.
Appendix
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Literature
1.
Hutchings A, Durand MA, Grieve R, Harrison D, Rowan K, Green J, et al. Evaluation of modernisation of adult critical care services in England: time series and cost effectiveness analysis. BMJ. 2009;339:b4353.PubMedPubMedCentralCrossRef
2.
Milbrandt E, Kersten A, Watson S, Rahim M, Clermont G, Angus D, et al. Rising use of intensive care unit services in Medicare. Crit Care. 2005;9(1):112.CrossRef
3.
Zimmerman JE, Kramer AA, Knaus WA. Changes in hospital mortality for United States intensive care unit admissions from 1988 to 2012. Crit Care. 2013;17(2):R81.PubMedPubMedCentralCrossRef
4.
Iwashyna TJ, Ely EW, Smith DM, Langa KM. Long-term cognitive impairment and functional disability among survivors of severe sepsis. JAMA. 2010;304(16):1787–94.PubMedPubMedCentralCrossRef
5.
Herridge M, Tansey C, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, et al. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011;364(14):1293–304.PubMedCrossRef
6.
National Institute for Health and Clinical Excellence. Rehabilitation after critical illness: NICE clinical guideline 83. London: National Institute for Health and Clinical Excellence; 2009. Available from: www.​nice.​org.​uk/​CG83.
7.
Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, et al. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003;348(8):683–93.PubMedCrossRef
8.
Wieske L, Dettling-Ihnenfeldt DS, Verhamme C, Nollet F, van Schaik IN, Schultz MJ, et al. Impact of ICU-acquired weakness on post-ICU physical functioning: a follow-up study. Crit Care. 2015;19(1):1–8.CrossRef
9.
Stevens RD, Marshall SA, Cornblath DR, Hoke A, Needham DM, De Jonghe B, et al. A framework for diagnosing and classifying intensive care unit-acquired weakness. Crit Care Med. 2009;37(Suppl 10):299–308.CrossRef
10.
Kress JP, Hall JB. ICU-acquired weakness and recovery from critical illness. N Engl J Med. 2014;370(17):1626–35.PubMedCrossRef
11.
Appleton RTD, Kinsella J, Quasim T. The incidence of intensive care unit-acquired weakness syndromes: a systematic review. J Intensive Care Soc. 2015;16(2):126–36.PubMedCrossRef
12.
13.
Khan J, Harrison TB, Rich MM, Moss M. Early development of critical illness myopathy and neuropathy in patients with severe sepsis. Neurology. 2006;67(8):1421–5.PubMedCrossRef
14.
Lewis A, Riddoch-Contreras J, Natanek SA, Donaldson A, Man WD-C, Moxham J, et al. Downregulation of the serum response factor/miR-1 axis in the quadriceps of patients with COPD. Thorax. 2012;67(1):26–34.PubMedCrossRef
15.
Mirzakhani H, Williams J-N, Mello J, Joseph S, Meyer MJ, Waak K, et al. Muscle weakness predicts pharyngeal dysfunction and symptomatic aspiration in long-term ventilated patients. Anesthesiology. 2013;119(2):1–9.CrossRef
16.
de Letter M-ACJ, Schmitz PIM, Visser LH, Verheul FAM, Schellens RLLA, Op de Coul DAW, et al. Risk factors for the development of polyneuropathy and myopathy in critically ill patients. Crit Care Med. 2001;29(12):2281–6.PubMedCrossRef
17.
Hodgson C, Bellomo R, Berney S, Bailey M, Buhr H, Denehy L, et al. Early mobilization and recovery in mechanically ventilated patients in the ICU: a bi-national, multi-centre, prospective cohort study. Crit Care. 2015;19(1):81.PubMedCrossRef
18.
Hermans G, Van Mechelen H, Clerckx B, Vanhullebusch T, Mesotten D, Wilmer A, et al. Acute outcomes and 1-year mortality of intensive care unit-acquired weakness: a cohort study and propensity-matched analysis. Am J Respir Crit Care Med. 2014;190(4):410–20.PubMedCrossRef
19.
Kelmenson DA, Held N, Allen RR, Quan D, Burnham EL, Clark BJ, et al. Outcomes of ICU patients with a discharge diagnosis of critical illness polyneuromyopathy: a propensity-matched analysis. Crit Care Med. 2017;45(12):2055–60.PubMedPubMedCentralCrossRef
20.
Garnacho-Montero J, Madrazo-Osuna J, García-Garmendia JL, Ortiz-Leyba C, Jimønez-Jimønez FJ, Barrero-Almodóvar A, et al. Critical illness polyneuropathy: risk factors and clinical consequences. A cohort study in septic patients. Intensive Care Med. 2001;27:1288–96.PubMedCrossRef
21.
Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, et al. Acute skeletal muscle wasting in critical illness. JAMA. 2013;310(15):1591–600.PubMedCrossRef
22.
23.
24.
25.
26.
Wollersheim T, Woehlecke J, Krebs M, Hamati J, Lodka D, Luther-Schroeder A, et al. Dynamics of myosin degradation in intensive care unit-acquired weakness during severe critical illness. Intensive Care Med. 2014;40(4):528–39.PubMedCrossRef
27.
Puthucheary ZA, Astin R, McPhail MJW, Saeed S, Pasha Y, Bear DE, et al. Metabolic phenotype of skeletal muscle in early critical illness. Thorax. 2018;73(10):926–35.PubMedCrossRef
28.
Reid MB, Judge AR, Bodine SC. CrossTalk opposing view: The dominant mechanism causing disuse muscle atrophy is proteolysis. J Physiol. 2014;592(24):5345–7.PubMedPubMedCentralCrossRef
29.
Fischer JR, Baer RK. Acute myopathy associated with combined use of corticosteroids and neuromuscular blocking agents. Ann Pharmacother. 1996;30(12):1437–45.PubMedCrossRef
30.
Puthucheary Z, Rawal J, Ratnayake G, Harridge S, Montgomery H, Hart N. Neuromuscular blockade and skeletal muscle weakness in critically ill patients: time to rethink the evidence? Am J Respir Crit Care Med. 2012;185(9):911–7.PubMedCrossRef
31.
Weber-Carstens S, Deja M, Koch S, Spranger J, Bubser F, Wernecke KD, et al. Risk factors in critical illness myopathy during the early course of critical illness: a prospective observational study. Crit Care. 2010;14(3):R119.PubMedPubMedCentralCrossRef
32.
Shepherd SJ, Newman R, Brett SJ, Griffith DM. Pharmacological therapy for the prevention and treatment of weakness after critical illness: a systematic review. Crit Care Med. 2016;44(6):1198–205.PubMedCrossRef
33.
Hermans G, De Jonghe B, Bruyninckx F, Van den Berghe G. Interventions for preventing critical illness polyneuropathy and critical illness myopathy. Cochrane Database Syst Rev. 2014;1:CD006832.
34.
Burtin C, Clerckx B, Robbeets C, Ferdinande P, Langer D, Troosters T, et al. Early exercise in critically ill patients enhances short-term functional recovery. Crit Care Med. 2009;37(9):2499–505.PubMedCrossRef
35.
Morris PE, Goad A, Thompson C, Taylor K, Harry B, Passmore L, et al. Early intensive care unit mobility therapy in the treatment of acute respiratory failure. Crit Care Med. 2008;36(8):2238–43.PubMedCrossRef
36.
Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, et al. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009;373(9678):1874–82.PubMedCrossRef
37.
Eggmann S, Verra ML, Luder G, Takala J, Jakob SM. Effects of early, combined endurance and resistance training in mechanically ventilated, critically ill patients: a study protocol for a randomised controlled trial. PLoS One. 2018;13(11):e0207428.PubMedPubMedCentralCrossRef
38.
Fossat G, Baudin F, Courtes L, Bobet S, Dupont A, Bretagnol A, et al. Effect of in-bed leg cycling and electrical stimulation of the quadriceps on global muscle strength in critically ill adults. JAMA. 2018;320(4):368.PubMedPubMedCentralCrossRef
39.
Fischer A, Spiegl M, Altmann K, Winkler A, Salamon A, Themessl-Huber M, et al. Muscle mass, strength and functional outcomes in critically ill patients after cardiothoracic surgery: does neuromuscular electrical stimulation help? The Catastim 2 randomized controlled trial. Crit Care. 2016;20(1):1–13.CrossRef
40.
Kho ME, Truong AD, Zanni JM, Ciesla ND, Brower RG, Palmer JB, et al. Neuromuscular electrical stimulation in mechanically ventilated patients: a randomized, sham-controlled pilot trial with blinded outcome assessment. J Crit Care. 2015;30(1):32–9.PubMedCrossRef
41.
Maffiuletti NA, Roig M, Karatzanos E, Nanas S. Neuromuscular electrical stimulation for preventing skeletal-muscle weakness and wasting in critically ill patients: a systematic review. BMC Med. 2013;11(1):137.PubMedPubMedCentralCrossRef
42.
Burke D, Gorman E, Stokes D, Lennon O. An evaluation of neuromuscular electrical stimulation in critical care using the ICF framework: a systematic review and meta-analysis. Clin Respir J. 2016;4:407–20.CrossRef
43.
Takarada Y, Takazawa H, Ishii N. Applications of vascular occlusion diminish disuse atrophy of knee extensor muscles. Med Sci Sports Exerc. 2000;32(12):2035–9.PubMedCrossRef
44.
De Groot PCE, Thijssen DHJ, Sanchez M, Ellenkamp R, Hopman MTE. Ischemic preconditioning improves maximal performance in humans. Eur J Appl Physiol. 2010;108(1):141–6.PubMedCrossRef
45.
Bailey TG, Jones H, Gregson W, Atkinson G, Cable NT, Thijssen DHJ. Effect of ischemic preconditioning on lactate accumulation and running performance. Med Sci Sports Exerc. 2012;44(11):2084–9.PubMedCrossRef
46.
Crisafulli A, Tangianu F, Tocco F, Concu A, Mameli O, Mulliri G, et al. Ischemic preconditioning of the muscle improves maximal exercise performance but not maximal oxygen uptake in humans. J Appl Physiol. 2011;111(2):530–6.PubMedCrossRef
47.
Jean-St-Michel E, Manlhiot C, Li J, Tropak M, Michelsen MM, Schmidt MR, et al. Remote preconditioning improves maximal performance in highly trained athletes. Med Sci Sports Exerc. 2011;43(7):1280–6.PubMedCrossRef
48.
Scott BR, Loenneke JP, Slattery KM, Dascombe BJ. Exercise with blood flow restriction: an updated evidence-based approach for enhanced muscular development. Sports Med. 2015;45(3):313–25.PubMedCrossRef
49.
Sumide T, Sakuraba K, Sawaki K, Ohmura H, Tamura Y. Effect of resistance exercise training combined with relatively low vascular occlusion. J Sci Med Sport. 2009;12(1):107–12.PubMedCrossRef
50.
Abe T, Yasuda T, Midorikawa T, Sato Y, Kearns CF, Inoue K, et al. Skeletal muscle size and circulating IGF-1 are increased after two weeks of twice daily ‘KAATSU’ resistance training. Int J Kaatsu Train Res. 2005;1:6–12.CrossRef
51.
Patterson SD, Ferguson RA. Increase in calf post-occlusive blood flow and strength following short-term resistance exercise training with blood flow restriction in young women. Eur J App Physiol. 2010;108:1025–33.CrossRef
52.
Abe T, Kearns CF, Sato Y. Muscle size and strength are increased following walk training with restricted venous blood flow from the leg muscle, Kaatsu-walk training. J Appl Physiol. 2006;100(5):1460–6.PubMedCrossRef
53.
Takarada Y, Sato Y, Ishii N. Effects of resistance exercise combined with vascular occlusion on muscular function in athletes. Eur J Appl Physiol. 2002;86:308–14.PubMedCrossRef
54.
Karabulut M, Abe T, Sato Y, Bemben MG. The effects of low-intensity resistance training with vascular restriction on leg muscle strength in older men. Eur J Appl Physiol. 2010;108(1):147–55.PubMedCrossRef
55.
Ozaki H, Sakamaki M, Yasuda T, Fujita S, Ogasawara R, Sugaya M, et al. Increases in thigh muscle volume and strength by walk training with leg blood flow reduction in older participants. J Gerontol A Biol Sci Med Sci. 2011;66(3):257–63.PubMedCrossRef
56.
Yasuda T, Fukumura K, Fukuda T, Uchida Y, Iida H, Meguro M, et al. Muscle size and arterial stiffness after blood flow-restricted low-intensity resistance training in older adults. Scand J Med Sci Sports. 2014;24(5):799–806.PubMedCrossRef
57.
Patterson SD, Ferguson RA. Enhancing strength and postocclusive calf blood flow in older people with training with blood-flow restriction. J Aging Phys Act. 2011;19(3):201–13.PubMedCrossRef
58.
Vechin FC, Libardi CA, Conceição MS, Damas FR, Lixandrão ME, Berton RPB, et al. Comparisons between low-intensity resistance training with blood flow restriction and high-intensity resistance training on quadriceps muscle mass and strength in elderly. J Strength Cond Res. 2015;29(4):1071–6.PubMedCrossRef
59.
Libardi CA, Chacon-Mikahil MP, Cavaglieri CR, Tricoli V, Roschel H, Vechin FC, et al. Effect of concurrent training with blood flow restriction in the elderly. Int J Sport Med. 2015;36:395–9.CrossRef
60.
Takarada Y, Takazawa H, Sato Y, Takebayashi S, Tanaka Y, Ishii N. Effects of resistance exercise combined with moderate vascular occlusion on muscular function in humans. J Appl Physiol. 2000;88:2097–106.PubMedCrossRef
61.
Mattar MA, Gualano B, Perandini LA, Shinjo SK, Lima FR, Sá-Pinto AL, et al. Safety and possible effects of low-intensity resistance training associated with partial blood flow restriction in polymyositis and dermatomyositis. Arthritis Res Ther. 2014;16(1):1–8.CrossRef
62.
Gualano B, Neves M, Lima FR, Pinto ALDS, Laurentino G, Borges C, et al. Resistance training with vascular occlusion in inclusion body myositis: a case study. Med Sci Sports Exerc. 2010;42(2):250–4.PubMedCrossRef
63.
Loenneke JP, Thiebaud RS, Abe T, Manfro IG, Marin PJ, Duan D, et al. Acute blood flow restricted exercise to treat Duchenne muscular dystrophy: would it be efficacious? Front Physiol. 2013;4(114):1–3.
64.
Kubota A, Sakuraba K, Sawaki K, Sumide T, Tamura Y. Prevention of disuse muscular weakness by restriction of blood flow. Med Sci Sports Exerc. 2008;40(3):529–34.PubMedCrossRef
65.
Cook SB, Brown KA, DeRuisseau K, Kanaley JA, Ploutz-Snyder LL. Skeletal muscle adaptations following blood flow-restricted training during 30 days of muscular unloading. J Appl Physiol. 2010;109(2):341–9.PubMedCrossRef
66.
Nakajima T, Yasuda T, Koide S, Yamasoba T, Obi S, Toyoda S, et al. Repetitive restriction of muscle blood flow enhances mTOR signaling pathways in a rat model. Heart Vessel. 2016;31(10):1685–95.CrossRef
67.
Cannavino J, Brocca L, Sandri M, Grassi B, Bottinelli R, Pellegrino MA. The role of alterations in mitochondrial dynamics and PGC-1α over-expression in fast muscle atrophy following hindlimb unloading. J Physiol. 2015;593(8):1981–95.PubMedPubMedCentralCrossRef
68.
Thaveau F, Zoll J, Rouyer O, Chafke N, Kretz JG, Piquard F, et al. Ischemic preconditioning specifically restores complexes I and II activities of the mitochondrial respiratory chain in ischemic skeletal muscle. J Vasc Surg. 2007;46(3):541–7.PubMedCrossRef
69.
Nakajima T, Koide S, Yasuda T, Hasegawa T, Yamasoba T, Obi S, et al. Muscle hypertrophy following blood flow-restricted low force isometric electrical stimulation in rat tibialis anterior: role for muscle hypoxia. J Appl Physiol. 2018;125:134–45.PubMedCrossRef
70.
Jeffries O, Waldron M, Pattison JR, Patterson SD. Enhanced local skeletal muscle oxidative capacity and microvascular blood flow following 7-day ischemic preconditioning in healthy humans. Front Physiol. 2018;9:463.PubMedPubMedCentralCrossRef
71.
Jones H, Hopkins N, Bailey TG, Green DJ, Cable NT, Thijssen DHJ. Seven-day remote ischemic preconditioning improves local and systemic endothelial function and microcirculation in healthy humans. Am J Hypertens. 2014;27(7):918–25.PubMedCrossRef
72.
Jones H, Nyakayiru J, Bailey TG, Green DJ, Cable NT, Sprung VS, et al. Impact of eight weeks of repeated ischaemic preconditioning on brachial artery and cutaneous microcirculatory function in healthy males. Eur J Prev Cardiol. 2015;22(8):1083–7.PubMedCrossRef
73.
Kimura M, Ueda K, Goto C, Jitsuiki D, Nishioka K, Umemura T, et al. Repetition of ischemic preconditioning augments endothelium-dependent vasodilation in humans: role of endothelium-derived nitric oxide and endothelial progenitor cells. Arterioscler Thromb Vasc Biol. 2007;27(6):1403–10.PubMedCrossRef
74.
Hamburg NM, Mcmackin CJ, Huang AL, Shenouda SM, Michael E, Schulz E, et al. Physical inactivity rapidly induces insulin resistance and microvascular dysfunction in healthy volunteers. Arterioscler Thromb Vasc Biol. 2007;27(12):2650–6.PubMedPubMedCentralCrossRef
75.
Birk GK, Dawson EA, Timothy Cable N, Green DJ, Thijssen DHJ. Effect of unilateral forearm inactivity on endothelium-dependent vasodilator function in humans. Eur J Appl Physiol. 2013;113(4):933–40.PubMedCrossRef
76.
Van Duijnhoven NTL, Green DJ, Felsenberg D, Belavý DL, Hopman MTE, Thijssen DHJ. Impact of bed rest on conduit artery remodeling: effect of exercise countermeasures. Hypertension. 2010;56(2):240–6.PubMedCrossRef
77.
Wexler O, Morgan MA, Gough MS, Steinmetz SD, Mack CM, Darling DC, et al. Brachial artery reactivity in patients with severe sepsis: an observational study. Crit Care. 2012;16(2):R38.PubMedPubMedCentralCrossRef
78.
Doerschug KC, Delsing AS, Schmidt GA, Haynes WG. Impairments in microvascular reactivity are related to organ failure in human sepsis. Am J Physiol Heart Circ Physiol. 2007;293:1065–71.CrossRef
79.
Creteur J, Carollo T, Soldati G, Buchele G, De Backer D, Vincent J-L. The prognostic value of muscle StO2 in septic patients. Intensive Care Med. 2007;33:1549–56.PubMedCrossRef
80.
Cheung MMH, Kharbanda RK, Konstantinov IE, Shimizu M, Frndova H, Li J, et al. Randomized controlled trial of the effects of remote ischemic preconditioning on children undergoing cardiac surgery. First clinical application in humans. J Am Coll Cardiol. 2006;47(11):2277–82.PubMedCrossRef
81.
Hausenloy DJ, Mwamure PK, Venugopal V, Harris J, Barnard M, Grundy E, et al. Effect of remote ischaemic preconditioning on myocardial injury in patients undergoing coronary artery bypass graft surgery: a randomised controlled trial. Lancet. 2007;370:575–9.PubMedCrossRef
82.
Ali ZA, Callaghan CJ, Lim E, Ali AA, Nouraei SAR, Akthar AM, et al. Remote ischemic preconditioning reduces myocardial and renal injury after elective abdominal aortic aneurysm repair: a randomized controlled trial. Circulation. 2007;116:98–105.CrossRef
83.
Hoole SP, Heck PM, Sharples L, Khan SN, Duehmke R, Densem CG, et al. Cardiac Remote Ischemic Preconditioning in Coronary Stenting (CRISP Stent) Study. A prospective, randomized control trial. Circulation. 2009;119(6):820–7.PubMedCrossRef
84.
Zarbock A, Schmidt C, Van Aken H, Wempe C, Martens S, Zahn PK, et al. Effect of remote ischemic preconditioning on kidney injury among high-risk patients undergoing cardiac surgery: a randomized clinical trial. JAMA. 2015;313(21):2133–41.PubMedCrossRef
85.
86.
Meng R, Asmaro K, Meng L, Liu Y, Ma C, Xi C, et al. Upper limb ischemic preconditioning prevents recurrent stroke in intracranial arterial stenosis. Neurology. 2012;79(18):1853–61.PubMedCrossRef
87.
Hausenloy DJ, Yellon DM. Remote ischaemic preconditioning: underlying mechanisms and clinical application. Cadiovasc Res. 2008;79:377–86.CrossRef
88.
Loenneke JP, Wilson JM, Wilson GJ, Pujol TJ, Bemben MG. Potential safety issues with blood flow restriction training. Scand J Med Sci Sport. 2011;21(4):510–8.CrossRef
89.
Takarada Y, Nakamura Y, Aruga S, Onda T, Miyazaki S, Ishii N. Rapid increase in plasma growth hormone after low-intensity resistance exercise with vascular occlusion. J Appl Physiol. 2000;88:61–5.PubMedCrossRef
90.
Page W, Swan R, Patterson SD. The effect of intermittent lower limb occlusion on recovery following exercise-induced muscle damage: a randomized controlled trial. J Sci Med Sport. 2017;20(8):729–33.PubMedCrossRef
91.
Franz A, Behringer M, Harmsen JF, Mayer C, Krauspe R, Zilkens C, et al. Ischemic preconditioning blunts muscle damage responses induced by eccentric exercise. Med Sci Sports Exerc. 2018;50(1):109–15.PubMedCrossRef
92.
Nakajima T, Kurano M, Iida H, Takano H, Oonuma H, Morita T, et al. Use and safety of KAATSU training: results of a national survey. Int J KAATSU Train Res. 2006;2(1):5–13.CrossRef
93.
Madarame H, Kurano M, Fukumura K, Fukuda T, Nakajima T. Haemostatic and inflammatory responses to blood flow-restricted exercise in patients with ischaemic heart disease: a pilot study. Clin Physiol Funct Imaging. 2013;33(1):11–7.PubMedCrossRef
94.
Staunton CA, May AK, Brandner CR, Warmington SA. Haemodynamics of aerobic and resistance blood flow restriction exercise in young and older adults. Eur J Appl Physiol. 2015;115(11):2293–302.PubMedCrossRef
95.
Clark BC, Manini TM, Hoffman RL, Williams PS, Guiler MK, Knutson MJ, et al. Relative safety of 4 weeks of blood flow-restricted resistance exercise in young, healthy adults. Scand J Med Sci Sport. 2011;21(5):653–62.CrossRef
96.
Koch S, Katsnelson M, Dong C, Perez-Pinzon M. Remote ischemic limb preconditioning after subarachnoid hemorrhage: a phase Ib study of safety and feasibility. Stroke. 2011;42(5):1387–91.PubMedPubMedCentralCrossRef
97.
Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004;10(2):307–12.PubMedCrossRef
98.
Sharma V, Cunniffe B, Verma AP, Cardinale M, Yellon D. Characterization of acute ischemia-related physiological responses associated with remote ischemic preconditioning: a randomized controlled, crossover human study. Physiol Rep. 2014;2:11.
99.
Seymour JM, Ward K, Sidhu PS, Puthucheary Z, Steier J, Jolley CJ, et al. Ultrasound measurement of rectus femoris cross-sectional area and the relationship with quadriceps strength in COPD. Thorax. 2009;64(5):418–23.PubMedCrossRef
100.
Sarwal A, Parry SM, Berry MJ, Hsu FC, Lewis MT, Justus NW, et al. Interobserver reliability of quantitative muscle sonographic analysis in the critically ill population. J Ultrasound Med. 2015;34(7):1191–200.PubMedCrossRef
101.
Parry SM, El-Ansary D, Cartwright MS, Sarwal A, Berney S, Koopman R, et al. Ultrasonography in the intensive care setting can be used to detect changes in the quality and quantity of muscle and is related to muscle strength and function. J Crit Care. 2015;30(5):1151.PubMedCrossRef
102.
Hunt JEA, Galea D, Tufft G, Bunce D, Ferguson RA. Time course of regional vascular adaptations to low load resistance training with blood flow restriction. J Appl Physiol. 2013;115:403–11.PubMedCrossRef
103.
Hermans G, Clerckx B, Vanhullebusch T, Segers J, Vanpee G, Robbeets C, et al. Interobserver agreement of Medical Research Council sum-score and handgrip strength in the intensive care unit. Muscle Nerve. 2012;45(1):18–25.PubMedCrossRef
104.
Hodgson C, Needham D, Haines K, Bailey M, Ward A, Harrold M, et al. Feasibility and inter-rater reliability of the ICU Mobility Scale. Hear Lung. 2014;43(1):19–24.CrossRef
105.
Tipping CJ, Bailey MJ, Bellomo R, Berney S, Buhr H, Denehy L, et al. The ICU Mobility Scale has construct and predictive validity and is responsive: a multicenter observational study. Ann Am Thorac Soc. 2016;13(6):887–93.PubMedCrossRef
106.
Mehta RL, Kellum JA, Shah SV, Molitoris BA, Ronco C, Warnock DG, et al. Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care. 2007;11(2):R31.PubMedPubMedCentralCrossRef
107.
de Roos B, Duthie SJ, Polley AC, Mulholland F, Bouwman FG, Heim C, et al. Proteomic methodological recommendations for studies involving human plasma, platelets, and peripheral blood mononuclear cells. J Proteome Res. 2008;7(6):2280–90.PubMedCrossRef
108.
van de Worp WRPH, Theys J, van Helvoort A, Langen RCJ. Regulation of muscle atrophy by microRNAs: ‘AtromiRs’ as potential target in cachexia. Curr Opin Clin Nutr Metab Care. 2018;21(6):423–9.PubMedCrossRef
109.
Harvey SE, Parrott F, Harrison DA, Bear DE, Segaran E, Beale R, et al. Trial of the route of early nutritional support in critically ill adults. N Engl J Med. 2014;371(18):1673–84.PubMedCrossRef
110.
Cook D, Crowther M, Meade M, Rabbat C, Griffith L, Schiff D, et al. Deep venous thrombosis in medical-surgical critically ill patients: prevalence, incidence, and risk factors. Crit Care Med. 2005;33(7):1565–71.PubMedCrossRef
111.
Hausenloy DJ, Candilio L, Evans R, Ariti C, Jenkins DP, Kolvekar S, et al. Remote ischemic preconditioning and outcomes of cardiac surgery. N Engl J Med. 2015;373(15):1408–17.PubMedCrossRef
Metadata
Title
Repetitive vascular occlusion stimulus (RVOS) versus standard care to prevent muscle wasting in critically ill patients (ROSProx):a study protocol for a pilot randomised controlled trial
Authors
Ismita Chhetri
Julie E. A. Hunt
Jeewaka R. Mendis
Stephen D. Patterson
Zudin A. Puthucheary
Hugh E. Montgomery
Benedict C. Creagh-Brown
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3547-5

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