The efficacy of high load-volume exercise versus low load-volume exercise for rotator cuff tendinopathy: A pilot and feasibility trial

Background: The most effective exercise variables for rotator cuff tendinopathy are unknown. Objective: Determine feasibility of a fully powered trial comparing high load-volume versus low load-volume exercise for adults with rotator cuff tendinopathy. Design: Two arm, multi-centre pilot and feasibility randomised controlled trial. Methods: Participants aged over 18 were recruited via social media and randomised into 12 weeks of either high load-volume exercise (i.e. with dumbbell resistance) or low load-volume exercise (i.e. without added resistance). Feasibility outcomes were rates of recruitment, retention, questionnaire completion, adverse events and adherence to prescribed exercise. Results: Fifteen participants were randomised to high load-volume and 16 to low load-volume (18/31 were female). Retention rate was 84% at 6 weeks, and 81% at 12 and 26 weeks. Five participants withdrew and one participant was lost to follow up. Questionnaire completion rate was 78%. Adherence to the prescribed exercise sets was 77%. Recruitment, conversion and retention rates were above the pre-defined success criterion. There were no serious adverse events. Conclusion: A fully powered multi-centre randomised trial is feasible with minor amendments addressing exercise adherence and questionnaire response rate. Future trials should utilise outcomes that consider participants baseline physical activity levels and adequately measure pain disparate from performance.