The effect of physiotherapy including frequent changes of body position and stimulation to physical activity for infants hospitalised with acute airway infections. Study protocol for a randomised controlled trial

Sonja Andersson-Marforio, Annika Lundkvist Josenby, Eva Ekvall Hansson, Christine Hansen, Sonja Andersson-Marforio, Annika Lundkvist Josenby, Eva Ekvall Hansson, Christine Hansen

Abstract

Background: Every year, many infants are infected with the respiratory syncytial virus (RSV) or other agents and need hospitalisation due to bronchiolitis. The disease causes much suffering and high costs. Thus, it is important that the treatment methods are both effective and cost-efficient. The use of different physiotherapy treatment methods is debated, and not all methods are evaluated scientifically. The clinical praxis in Sweden that includes frequent changes of body position and stimulation to physical activity has not previously been evaluated. The aim of this clinical study is to evaluate this praxis.

Methods: This study is a clinical two-centre individually randomised controlled trial (RCT) with three parallel groups. The participants will be randomly assigned to an individualised physiotherapy intervention, a non-individualised intervention, or a control group. All three groups will receive the standard care at the ward, and the two intervention groups will receive additional treatment, including different movements of the body. The primary outcome measure is a clinical index based on determinants for hospitalisation. Baseline assessments will be compared with the assessments after 24 h. The secondary outcome measures include vital signs, the parents' observations, time spent at the hospital ward, and referrals to an intensive care unit. We also want see if there is any immediate effect of the first intervention, after 20 min.

Discussion: This study will add knowledge about the effect of two physiotherapy interventions that are commonly in use in Swedish hospitals for infants with bronchiolitis or other acute lower respiratory tract infections.

Trial registration: ClinicalTrials.gov NCT03575091 . Registered July 2, 2018-retrospectively registered.

Keywords: Bronchiolitis; Chest physiotherapy; Infants; Physiotherapy; Pneumonia; Randomised controlled trial; Treatment.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow chart of the study design
Fig. 2
Fig. 2
The SPIRIT figure of enrolment, interventions, assessments, and outcomes
Fig. 3
Fig. 3
Example of movement in the individualised intervention group. The physiotherapist bounces on a large ball while holding the infant in different body positions approximately 20 s in each position
Fig. 4
Fig. 4
Example of body position in the non-individualised intervention group, where the nursing staff changes the infant’s body position in their arms

References

    1. Midulla F, Nicolai A, Moretti C. Acute viral bronchiolitis. In: Eber E, Midulla F, editors. ERS Handbook of paediatric respiratory medicine. 1 ed. Sheffield: The European Respiratory Society; 2013. pp. 305–309.
    1. Nair H, Simoes EA, Rudan I, Gessner BD, Azziz-Baumgartner E, Zhang JS, et al. Global and regional burden of hospital admissions for severe acute lower respiratory infections in young children in 2010: a systematic analysis. Lancet (London, England) 2013;381(9875):1380–1390. doi: 10.1016/S0140-6736(12)61901-1.
    1. Munoz-Quiles C, Lopez-Lacort M, Ubeda-Sansano I, Aleman-Sanchez S, Perez-Vilar S, Puig-Barbera J, et al. Population-based analysis of bronchiolitis epidemiology in Valencia, Spain. Pediatr Infect Dis J. 2016;35(3):275–280. doi: 10.1097/INF.0000000000000993.
    1. Florin TA, Plint AC, Zorc JJ. Viral bronchiolitis. Lancet. 2017;389(10065):211–224. doi: 10.1016/S0140-6736(16)30951-5.
    1. Gajdos V, Katsahian S, Beydon N, Abadie V, de Pontual L, Larrar S, et al. Effectiveness of chest physiotherapy in infants hospitalized with acute bronchiolitis: a multicenter, randomized, controlled trial. PLoS Med. 2010;7(9):e1000345. doi: 10.1371/journal.pmed.1000345.
    1. Lannefors L. Cystic fibrosis-long term results of a treatment package including preventive physical exercise [dissertation] Lund: Lund University; 2010.
    1. Postiaux G, Zwaenepoel B, Louis J. Chest physical therapy in acute viral bronchiolitis: an updated review. Respir Care. 2013;58(9):1541–1545. doi: 10.4187/respcare.01890.
    1. Gomes EL, Postiaux G, Medeiros DR, Monteiro KK, Sampaio LM, Costa D. Chest physical therapy is effective in reducing the clinical score in bronchiolitis: randomized controlled trial. Rev Bras Fisioter. 2012;16(3):241–247. doi: 10.1590/S1413-35552012005000018.
    1. Rochat I, Leis P, Bouchardy M, Oberli C, Sourial H, Friedli-Burri M, et al. Chest physiotherapy using passive expiratory techniques does not reduce bronchiolitis severity: a randomised controlled trial. Eur J Pediatr. 2012;171(3):457–462. doi: 10.1007/s00431-011-1562-y.
    1. Gomes GR, Donadio MF. Effects of the use of respiratory physiotherapy in children admitted with acute viral bronchiolitis. Archives de Pédiatrie. 2018;25(6):394–98.
    1. Roque i Figuls M, Gine-Garriga M, Granados Rugeles C, Perrotta C, Vilaro J. Chest physiotherapy for acute bronchiolitis in paediatric patients between 0 and 24 months old. Cochrane Database Syst Rev. 2016;2:CD004873.
    1. DiDario AG, Whelan MA, Hwan WH, Yousef E, Cox TJ, Oldham HM, et al. Efficacy of chest physiotherapy in pediatric patients with acute asthma exacerbations. Pediatric Asthma Allergy Immunol. 2009;22(2):69–74. doi: 10.1089/pai.2009.0004.
    1. Giannantonio C, Papacci P, Ciarniello R, Tesfagabir MG, Purcaro V, Cota F, et al. Chest physiotherapy in preterm infants with lung diseases. Ital J Pediatr. 2010;36:65. doi: 10.1186/1824-7288-36-65.
    1. Jacinto CP, Gastaldi AC, Aguiar DY, Maida KD, Souza HC. Physical therapy for airway clearance improves cardiac autonomic modulation in children with acute bronchiolitis. Brazilian J Phys Ther. 2013;17(6):533–540. doi: 10.1590/S1413-35552012005000120.
    1. Kugelman A, Feferkorn I, Riskin A, Chistyakov I, Kaufman B, Bader D. Nasal intermittent mandatory ventilation versus nasal continuous positive airway pressure for respiratory distress syndrome: a randomized, controlled, prospective study. J Pediatr. 2007;150(5):521–526. doi: 10.1016/j.jpeds.2007.01.032.
    1. Lukrafka JL, Fuchs SC, Fischer GB, Flores JA, Fachel JM, Castro-Rodriguez JA. Chest physiotherapy in paediatric patients hospitalised with community-acquired pneumonia: a randomised clinical trial. Arch Dis Child. 2012;97(11):967–971. doi: 10.1136/archdischild-2012-302279.
    1. Milesi C, Matecki S, Jaber S, Mura T, Jacquot A, Pidoux O, et al. 6 cmH2O continuous positive airway pressure versus conventional oxygen therapy in severe viral bronchiolitis: a randomized trial. Pediatr Pulmonol. 2013;48(1):45–51. doi: 10.1002/ppul.22533.
    1. Paludo C, Zhang L, Lincho CS, Lemos DV, Real GG, Bergamin JA. Chest physical therapy for children hospitalised with acute pneumonia: a randomised controlled trial. Thorax. 2008;63(9):791–794. doi: 10.1136/thx.2007.088195.
    1. Postiaux G, Louis J, Labasse HC, Gerroldt J, Kotik AC, Lemuhot A, et al. Evaluation of an alternative chest physiotherapy method in infants with respiratory syncytial virus bronchiolitis. Respir Care. 2011;56(7):989–994. doi: 10.4187/respcare.00721.
    1. Pupin MK, Riccetto AG, Ribeiro JD, Baracat EC. Comparison of the effects that two different respiratory physical therapy techniques have on cardiorespiratory parameters in infants with acute viral bronchiolitis. J Bras Pneumol. 2009;35(9):860–867. doi: 10.1590/S1806-37132009000900007.
    1. Thia LP, McKenzie SA, Blyth TP, Minasian CC, Kozlowska WJ, Carr SB. Randomised controlled trial of nasal continuous positive airways pressure (CPAP) in bronchiolitis. Arch Dis Child. 2008;93(1):45–47. doi: 10.1136/adc.2005.091231.
    1. Andersson-Marforio S, Hansen C, Ekvall Hansson E, Lundkvist Josenby A. A survey of the physiotherapy treatment methods for infants hospitalised with acute airway infections in Sweden. Eur J Phys. 2019. 10.1080/21679169.2019.1663925.
    1. Dean E. Body positioning. In: Frownfelter DL, Dean E, editors. Cardiovascular and pulmonary physical therapy: evidence to practice. 5. St. Louis, Mo: Elsevier/Mosby; 2013. pp. 293–308.
    1. Dean E, Butchers S. Mobilization and exercise: physiological basis for assessment, evaluation and training. In: Frownfelter D, Dean E, editors. Cardiovascular and pulmonary physical therapy: evidence to practice. 5. St. Louis, Mo: Elsevier/Mosby; 2013. pp. 293–308.
    1. Lumb AB. Nunn’s applied respiratory physiology. 8. New York: Elsevier; 2017. pp. 451–452.
    1. Gillies D, Wells D, Bhandari AP. Positioning for acute respiratory distress in hospitalised infants and children. Cochrane Database Syst Rev. 2012;7:CD003645.
    1. Baudin F, Emeriaud G, Essouri S, Beck J, Portefaix A, Javouhey E, et al. Physiological effect of prone position in children with severe bronchiolitis: a randomized cross-over study (BRONCHIO-DV) J Pediatr. 2019;205:112–119. doi: 10.1016/j.jpeds.2018.09.066.
    1. The National Institute for Health and Care Excellence (NICE). Bronchiolitis in children: diagnosis and management. NICE guideline NG9 [Internet]. Manchester: The National Institute for Health and Care Excellence; 2015 [cited 2019 16 August]. Available from: .
    1. Läkemedelskommittén i Västra Götalandsregionen. Vätske- och nutritionsbehandling [Internet]. [Therapy group Fluids and nutrition] Göteborg: Läkemedelskommittén i Västa Götalandsregionen; 2011 [cited 2019 30 Oktober]. Available from: .
    1. Shaw V, Lawson M. Nutritional assessment, dietary requirements, feed supplementation. In: Shaw V, Lawson M, editors. Clinical paediatric dietetics. 3. Oxford: Wiley-Blackwell; 2007. p. 13.
    1. Wang EE, Milner RA, Navas L, Maj H. Observer agreement for respiratory signs and oximetry in infants hospitalized with lower respiratory infections. Am Rev Respir Dis. 1992;145(1):106–109. doi: 10.1164/ajrccm/145.1.106.
    1. Chin HJ, Seng QB. Reliability and validity of the respiratory score in the assessment of acute bronchiolitis. Malaysian J Med Sciences : MJMS. 2004;11(2):34–40.
    1. Gajdos V, Beydon N, Bommenel L, Pellegrino B, de Pontual L, Bailleux S, et al. Inter-observer agreement between physicians, nurses, and respiratory therapists for respiratory clinical evaluation in bronchiolitis. Pediatr Pulmonol. 2009;44(8):754–762. doi: 10.1002/ppul.21016.
    1. Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP) Arthritis Care Res (Hoboken) 2011;63(Suppl 11):S240–S252. doi: 10.1002/acr.20543.
    1. Oldenmenger WH, de Raaf PJ, de Klerk C, van der Rijt CC. Cut points on 0-10 numeric rating scales for symptoms included in the Edmonton Symptom Assessment Scale in cancer patients: a systematic review. J Pain Symptom Manag. 2013;45(6):1083–1093. doi: 10.1016/j.jpainsymman.2012.06.007.
    1. Wikström L, Nilsson M, Broström A, Eriksson K. Patients’ self-reported nausea: Validation of the Numerical Rating Scale and of a daily summary of repeated Numerical Rating Scale scores. J Clin Nurs. 2019;28(5–6):959–968. doi: 10.1111/jocn.14705.
    1. Horn KK, Jennings S, Richardson G, Vliet DV, Hefford C, Abbott JH. The patient-specific functional scale: psychometrics, clinimetrics, and application as a clinical outcome measure. J Orthop Sports Phys Ther. 2012;42(1):30–42. doi: 10.2519/jospt.2012.3727.
    1. Selby D, Cascella A, Gardiner K, Do R, Moravan V, Myers J, et al. A single set of numerical cutpoints to define moderate and severe symptoms for the Edmonton Symptom Assessment System. J Pain Symptom Manag. 2010;39(2):241–249. doi: 10.1016/j.jpainsymman.2009.06.010.
    1. Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008;337:a2390. doi: 10.1136/bmj.a2390.
    1. Nagakumar P, Doull I. Current therapy for bronchiolitis. Arch Dis Child. 2012;97(9):827. doi: 10.1136/archdischild-2011-301579.
    1. Sveriges riksdag. Lag (2003:460) om etikprövning av forskning som avser människor Stockholm: The Swedish parliament (Riksdag); 2003 [cited 2019 28 August]. Summary in English p 31-44. Available from: .

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