Improved 6-minute walk distance after Pulmonary Rehabilitation in primary care: a randomized, controlled, pragmatic trial in patients with long COVID (PuRe-COVID)

<bold>Introduction:</bold> Long COVID is a prevalent condition, often involving fatigue and dyspnoea. The evidence for beneficial effects of pulmonary rehabilitation (PR) in primary care is not available. <bold>Aim:</bold> To study the effect of primary care PR on exercise capacity in patients with long COVID. <bold>Methods:</bold> Long COVID patients, with dyspnea and/or fatigue, were randomized to a 12-week PR program in primary care, supervised by a physiotherapist, or to a control group not following PR, with a subsequent follow-up period up to 24-weeks (<ext-link>NCT05244044</ext-link>; <italic>Volckaerts et al. 2023</italic>). As primary outcome analysis a linear mixed model using 6-minute walking distance (6MWD) measurements at baseline, week 6, 12 and 24 was fitted to estimate the treatment effect between the two groups at 12 weeks. In this model time, group (PR versus control) and the interaction between both were considered as fixed effects and subject as random effect. <bold>Results:</bold> In the intention-to-treat dataset 76 randomized patients (39 PR, 37 control) were considered (64.5% females, age 49±13 years). A highly significant interaction term was found (p-value <0.0001) revealing a significant different evolution of the 6MWD over 24 weeks between both groups. The linear mixed model estimated the treatment effect at week 12, the primary endpoint, as 43.3m 95% CI [−4.8,91.3] m (p=0.077). Adjustment for confounders, different sensitivity analyses and analyses of secondary and exploratory outcomes will be considered next to describe all aspects of the PR effect. <bold>Conclusions:</bold> Primary care PR may improve exercise capacity in patients with long COVID who present with dyspnoea and/or fatigue.