Objectives: The SPeEDy study (Surgery vs. physiotherapist-led exercise for traumatic tears of the rotator cuff) is a two-arm, parallel group, pilot and feasibility randomised controlled trial aiming to evaluate the feasibility of a future main trial. In this paper, the development process and the resultant physiotherapist-led exercise programme used in the SPeEDy study is described.
Methods: Thirteen physiotherapists and three patients met to discuss and develop the key principles that should underpin the exercise programme.
Results: Taking in to account the current research evidence and incorporating expert clinical and patient opinion, the group developed an individualised, structured and progressive physiotherapist-led exercise programme based on the principle of self dosing. Exercise prescription within the programme is based on establishing the current functional capacity of the patient in relation to the most challenging shoulder movements and is supported over approximately six contact sessions across a 12-week period.
Conclusion: The SPeEDy study aims to recruit 76 participants across eight hospitals and will provide high quality evidence about the feasibility of a future main randomised controlled trial in a clinical area where there is a lack of evidence from randomised controlled trials to support clinical decision-making. ClinicalTrials.gov (NCT04027205) - Registered on 19 July 2019. Available via https://clinicaltrials.gov/ct2/show/NCT04027205.
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