Trials (Sep 2020)
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
Abstract
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.
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