Oral Supplementation During PR Participation in COPD

The main objectives for this pilot feasibility study are to document recruitment rates, collect information on participant acceptability of tests, establish the capacity to run the RCT at our site, to demonstrate successful molecular testing of specimens, and to generate pilot data for the outcomes being tested in the larger subsequent RCT. The overarching goal for the 'larger', future project will be to determine the effect of the oral supplement on exercise capacity, muscle strength, mitochondrial function, health-related quality of life, cognition, symptom burden, and safety/adherence in patients with COPD who are participating in a Pulmonary Rehabilitation program. The goal of the present research project is to complete a pilot and feasibility study testing the same clinical outcomes on a smaller sample of eligible study participants during which participants receive the intervention for 8 weeks. The primary objective is to determine whether administration of the oral supplement during participation in a standard multi-week in-person Pulmonary Rehabilitation (PR) program is associated with an improvement in exercise endurance capacity in patients with COPD, compared with PR participation and placebo supplementation. The secondary objectives are to determine the effect of the oral supplement on i) global conditioning and exercise capacity; ii) muscle strength; iii) mitochondrial function; iv) body composition; v) quality of life and burden of disease; vi) cognition; vii) adverse events/complications and adherence, and viii) blood levels of Urolithin A. We hypothesize that patients with COPD receiving oral supplementation during PR participation will demonstrate an improvement in Constant Work Rate Exercise Test (CRWET) time after 8 weeks when compared to patients with COPD who receive placebo and PR participation.