EarLy Exercise in blunt Chest wall Trauma: a feasibility trial (ELECT Trial)
Ceri Battle1, Claire O'Neill2, Hannah Toghill3
1Physiotherapy Department, Morriston Hospital, Swansea Bay University Health Board, Swansea, UK ceri.battle@wales.nhs.uk.
Background:
The aim was to complete a feasibility study that would test the methods of the main trial, that will investigate whether early thoracic and shoulder girdle exercises reduce chronic pain in patients with blunt chest wall trauma, when compared with normal care.
Methods:
A single centre, parallel, feasibility randomised controlled trial was completed at a University Teaching Hospital in Wales between June and September 2019. Adult patients with blunt chest wall trauma, admitted to hospital for greater than 24 hours, with no concurrent, immediately life-threatening injuries, were included. The intervention was a simple physiotherapy programme comprising thoracic and shoulder girdle exercises. Feasibility outcome measures included: primary outcomes: (1) 80% or more of identified eligible patients were approached for potential recruitment to the trial (2) 30% or less of approached, eligible patients dissented to participate in the trial; secondary outcomes: (3) follow-up data for patient secondary outcomes can be collected for 80% or more of patients, (4) there should be no greater than 10% increase in serious adverse events in the intervention group compared with the control group.
Results:
A total of 19/19 (100%) patients were deemed eligible for the trial and were approached for participation, 5/19 (26%) eligible patients declined to participate in the trial, follow-up data were collected for n=10/14 (71%) patients and there were no serious adverse events reported in either group.
Conclusions:
We have demonstrated that a fully powered randomised clinical trial of the EarLy Exercise in blunt Chest wall Trauma Trial is feasible.
Trial Registration Number:
ISRCTN16197429.
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