Physiotherapy interventions encouraging frequent changes of the body position and physical activity for infants hospitalised with bronchiolitis : an internal feasibility study of a randomised control trial
Andersson-Marforio, Sonja LU
; Lundkvist Josenby, Annika
LU
; Hansen, Christine
and Ekvall Hansson, Eva
LU
(2022)
In Pilot and Feasibility Studies
8.
p.1-10
- Abstract
BACKGROUND: The effect of a treatment that includes frequent changes of the body position for infants with bronchiolitis has not been evaluated, although it is often used in Swedish hospitals. Because of this, a randomised control trial (RCT) has begun with the aim to evaluate this treatment, comparing the effect of an individualised physiotherapy intervention, a non-individualised intervention, and standard care in a control group. The objective of this internal pilot study was to address uncertainties concerning the ongoing RCT and to determine whether the trial is feasible or not, possibly with adjustments to the protocol.
METHODS: Descriptive analyses of the recruitment, retention, data supply for the primary end point, and... (More)
BACKGROUND: The effect of a treatment that includes frequent changes of the body position for infants with bronchiolitis has not been evaluated, although it is often used in Swedish hospitals. Because of this, a randomised control trial (RCT) has begun with the aim to evaluate this treatment, comparing the effect of an individualised physiotherapy intervention, a non-individualised intervention, and standard care in a control group. The objective of this internal pilot study was to address uncertainties concerning the ongoing RCT and to determine whether the trial is feasible or not, possibly with adjustments to the protocol.
METHODS: Descriptive analyses of the recruitment, retention, data supply for the primary end point, and the usability of the primary outcome measure in the full RCT were performed. A safety analysis was conducted by an independent analysis group.
RESULTS: Ninety-one infants were included, 33 (36.3%), 28 (30.8%), and 30 (33.0%) in the respective allocation groups. Fifty-nine (64.8%) were boys. The median age was 2.5 (min-max 0.2-23.7) months. They remained in the study for a median of 46 hours (min-max 2-159). The recruitment rate was 19%. The data supply for the primary end point and for the primary outcome measure was lower than anticipated in the original sample size calculation. Difficulties concerning utilising the primary outcome measure were identified. The safety analysis detected no risks of harm related to participation in the study.
CONCLUSIONS: It is feasible to continue the RCT with modifications of the analysis plan. Participation in the study was not associated with any safety risks.
TRIAL REGISTRATION: ClinicalTrials.gov NCT03575091 . Registered 2 July 2018. Retrospectively registered.
(Less)
- author
- Andersson-Marforio, Sonja
LU
; Lundkvist Josenby, Annika
LU
; Hansen, Christine
and Ekvall Hansson, Eva
LU
- organization
- publishing date
- 2022
- type
- Contribution to journal
- publication status
- published
- subject
- in
- Pilot and Feasibility Studies
- volume
- 8
- article number
- 76
- pages
- 1 - 10
- publisher
- BioMed Central (BMC)
- external identifiers
-
- scopus:85127524859
- pmid:35351205
- ISSN
- 2055-5784
- DOI
- 10.1186/s40814-022-01030-2
- project
- Infants hospitalised with acute respiratory tract infections Mapping, description, and evaluation of physiotherapy treatment methods including frequent changes in body position and stimulation of physical activity
- language
- English
- LU publication?
- yes
- additional info
- © 2022. The Author(s).
- id
- 78fee53c-1e36-4e84-9e38-948afea90a68
- date added to LUP
- 2022-04-11 13:05:52
- date last changed
- 2024-06-16 13:54:09
@article{78fee53c-1e36-4e84-9e38-948afea90a68,
abstract = {{<p>BACKGROUND: The effect of a treatment that includes frequent changes of the body position for infants with bronchiolitis has not been evaluated, although it is often used in Swedish hospitals. Because of this, a randomised control trial (RCT) has begun with the aim to evaluate this treatment, comparing the effect of an individualised physiotherapy intervention, a non-individualised intervention, and standard care in a control group. The objective of this internal pilot study was to address uncertainties concerning the ongoing RCT and to determine whether the trial is feasible or not, possibly with adjustments to the protocol.</p><p>METHODS: Descriptive analyses of the recruitment, retention, data supply for the primary end point, and the usability of the primary outcome measure in the full RCT were performed. A safety analysis was conducted by an independent analysis group.</p><p>RESULTS: Ninety-one infants were included, 33 (36.3%), 28 (30.8%), and 30 (33.0%) in the respective allocation groups. Fifty-nine (64.8%) were boys. The median age was 2.5 (min-max 0.2-23.7) months. They remained in the study for a median of 46 hours (min-max 2-159). The recruitment rate was 19%. The data supply for the primary end point and for the primary outcome measure was lower than anticipated in the original sample size calculation. Difficulties concerning utilising the primary outcome measure were identified. The safety analysis detected no risks of harm related to participation in the study.</p><p>CONCLUSIONS: It is feasible to continue the RCT with modifications of the analysis plan. Participation in the study was not associated with any safety risks.</p><p>TRIAL REGISTRATION: ClinicalTrials.gov NCT03575091 . Registered 2 July 2018. Retrospectively registered.</p>}},
author = {{Andersson-Marforio, Sonja and Lundkvist Josenby, Annika and Hansen, Christine and Ekvall Hansson, Eva}},
issn = {{2055-5784}},
language = {{eng}},
pages = {{1--10}},
publisher = {{BioMed Central (BMC)}},
series = {{Pilot and Feasibility Studies}},
title = {{Physiotherapy interventions encouraging frequent changes of the body position and physical activity for infants hospitalised with bronchiolitis : an internal feasibility study of a randomised control trial}},
url = {{http://dx.doi.org/10.1186/s40814-022-01030-2}},
doi = {{10.1186/s40814-022-01030-2}},
volume = {{8}},
year = {{2022}},
}