TY - JOUR T1 - A double-blind, randomised, controlled trial of protein supplementation to enhance exercise capacity in COPD during pulmonary rehabilitation: a pilot study JF - ERJ Open Research JO - erjor DO - 10.1183/23120541.00077-2021 SP - 00077-2021 AU - Abdulelah M. Aldhahir AU - Yousef S. Aldabayan AU - Jaber S. Alqahtani AU - Heidi A. Ridsdale AU - Colette Smith AU - John R. Hurst AU - Swapna Mandal Y1 - 2021/01/01 UR - http://openres.ersjournals.com/content/early/2021/02/04/23120541.00077-2021.abstract N2 - Background Pulmonary rehabilitation (PR) is a cost-effective management strategy in chronic obstructive pulmonary disease (COPD) which improves exercise performance and health-related quality of life. Nutritional supplementation may counter malnutrition and enhance PR outcomes but rigorous evidence is absent. We aimed to investigate the effect of high protein-supplementation (Fortisip Compact Protein, FCP) during PR on exercise capacity.Methods A double-blind randomised controlled trial comparing FCP with preOp (a carbohydrate control supplement) in COPD patients participating in a PR programme. Participants consumed the supplement twice a day during PR and attended twice-weekly PR sessions, with pre- and post-PR measurements including the incremental shuttle walk test (ISWT) at 6-weeks as the primary outcome. Participants’ experience using supplements was assessed.Results Sixty-eight patients were recruited; (FCP: 36 and control: 32). The trial was stopped early due to COVID-19. Although statistical significance was not reached, there was the suggestion of a clinically meaningful difference in ISWT at 6 weeks favouring the intervention group (intervention: 342 m±149; n=22 versus control: 305 m±148; n=22, p=0.1). Individuals who achieved an improvement in ISWT had larger mid-thigh circumference at baseline (responder: 62 cm±4 versus non-responder: 55 cm±6; p=0.006). 79% were satisfied with the taste and 43% would continue taking the FCP.Conclusion Although the data did not demonstrate a statistically significant difference in ISWT, high protein supplementation in COPD during PR may result in a clinically meaningful improvement in exercise capacity and was acceptable to patients. Large, adequately powered studies are justified.FootnotesThis manuscript has recently been accepted for publication in the ERJ Open Research. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJOR online. Please open or download the PDF to view this article.Conflict of interest: Dr. Aldhahir has nothing to disclose.Conflict of interest: Dr. Aldabayan has nothing to disclose.Conflict of interest: Dr. Alqahtani has nothing to disclose.Conflict of interest: Dr. Ridsdale has nothing to disclose.Conflict of interest: C. Smith reports personal fees for educational materials from Gilead and grants from ViiV Healthcare outside the submitted work.Conflict of interest: Dr. Hurst reports support to attend meetings, and payment for educational and advisory work, personally, and University College London received payment for educational activity and advisory work from pharmaceutical companies that make medicines to treat COPD, outside the submitted work.Conflict of interest: Dr. Mandal has nothing to disclose. ER -