A double-blind randomised controlled trial of protein supplementation to enhance exercise capacity in COPD during pulmonary rehabilitation: a pilot study

Abdulelah M Aldhahir; Yousef S Aldabayan; Jaber S Alqahtani; Heidi A Ridsdale; Colette Smith; John R Hurst; Swapna Mandal

doi:10.1183/23120541.00077-2021

A double-blind randomised controlled trial of protein supplementation to enhance exercise capacity in COPD during pulmonary rehabilitation: a pilot study

ERJ Open Res. 2021 Mar 29;7(1):00077-2021. doi: 10.1183/23120541.00077-2021. eCollection 2021 Jan.

Authors

Abdulelah M Aldhahir^{1

2}, Yousef S Aldabayan^{1

3}, Jaber S Alqahtani^{1

4}, Heidi A Ridsdale⁵, Colette Smith⁶, John R Hurst^{1

7

8}, Swapna Mandal^{1

7

8}

Affiliations

¹ UCL Respiratory, Royal Free Campus, University College London, London, UK.
² Respiratory Therapy Dept, Faculty of Applied Medical Sciences, Jazan University, Jazan, Saudi Arabia.
³ Respiratory Care Dept, College of Applied Medical Sciences, King Faisal University, Al-Hasa, Saudi Arabia.
⁴ Dept of Respiratory Care, Prince Sultan Military College of Health Sciences, Dammam, Saudi Arabia.
⁵ Central and North West London NHS Foundation Trust, London, UK.
⁶ Research Dept of Infection and Population Health, University College London, London, UK.
⁷ Royal Free London NHS Foundation Trust, London, UK.
⁸ These authors contributed equally to this work.

Abstract

Background: Pulmonary rehabilitation 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 pulmonary rehabilitation outcomes but rigorous evidence is absent. We aimed to investigate the effect of high-protein supplementation (Fortisip Compact Protein (FCP)) during pulmonary rehabilitation on exercise capacity.

Methods: This was a double-blind randomised controlled trial comparing FCP (intervention) with PreOp (a carbohydrate control supplement) in COPD patients participating in a pulmonary rehabilitation programme. Participants consumed the supplement twice a day during pulmonary rehabilitation and attended twice-weekly pulmonary rehabilitation sessions, with pre- and post-pulmonary rehabilitation measurements, including the incremental shuttle walk test (ISWT) distance at 6 weeks as the primary outcome. Participants' experience using supplements was assessed.

Results: 68 patients were recruited (intervention n=36 and control n=32). The trial was stopped early due to the COVID-19 pandemic. Although statistical significance was not reached, there was the suggestion of a clinically meaningful difference in the ISWT distance at 6 weeks favouring the intervention group (intervention 342±149 m (n=22) versus control 305±148 m (n=22); p=0.1). Individuals who achieved an improvement in the ISWT had a larger mid-thigh circumference at baseline (responders 62±4 cm versus nonresponders 55±6 cm; p=0.006). 79% of the patients were satisfied with the taste and 43% would continue taking the FCP.

Conclusions: Although the data did not demonstrate a statistically significant difference in the ISWT, high-protein supplementation in COPD during pulmonary rehabilitation may result in a clinically meaningful improvement in exercise capacity and was acceptable to patients. Large, adequately powered studies are justified.