Effects of Home-Based Respiratory Physiotherapy and Telephone- Based Psychological Support on Pulmonary and Mental Health Outcomes in Peru: A Feasibility Randomized Controlled Trial

ABSTRACT

Introduction: We sought to determine whether a 6-week integrated rehabilitation program improved pulmonary function, physical and mental health outcomes in patients discharged alive after surviving a severe COVID-19 pneumonia. Methods: Parallel, open-label, feasibility randomized controlled trial in participants aged 18-75 years who were discharged for severe COVID-19 pneumonia. The intervention consisted of 12 in-person home respiratory rehabilitation sessions and 6 telephonebased, emotion-centered problem-solving therapy psychological sessions. We measured the 6- minute walk test (6MWT), forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC), Patient Health Questionnaire (PHQ-9), General Anxiety Disorder (GAD-7), Impact of Event Scale- Revised (IES-R) and Short Form 36 health survey (SF-36). Following the recommendation by Cocks and Torgerson, we used a one-sided 80% confidence interval to determine if this feasibility trial should proceed to a phase III trial. Results: We randomized 103 participants (mean age, 48 years;71% men). There were no differences at baseline assessments of outcomes between the two groups. Intervention participants walked 15 and 45 meters more during a 6MWT at 7 and 12 weeks, respectively, than controls after accounting for baseline distance. In both instances, the onesided 80% lower bound was above 0. Intervention participants also had a greater improvement of lung function for week 7 (mean difference FEV1, 0.05 L;95% CI, -0.14 to 0.24;mean difference FVC, 0.10 L;95% CI, -0.12 to 0.31) and at week 12 (mean difference FEV1, 0.10 L;95% CI, -0.18 to 0.37;mean difference FVC, 0.15 L;95% CI, -0.17 to 0.47). Likewise, the prevalence of depression (percentage difference PHQ-9, 24.3%;95% CI, -4.3 to 44.3), anxiety (percentage difference GAD-7, 20.7%;95% CI, 0.8 to 40.6) and post-traumatic stress (percentage difference IES-R, 14.0%;95% CI, -5.7 to 33.7) were lower in the intervention group at week 2 after hospital discharge. At week 7, the intervention group had a greater improvement of physical (mean difference, 10.8;95% CI, -1.8 to 23.4) and social (mean difference, 6.43;95% CI, -0.65 to 13.5) function on the SF-36. Conclusion: We demonstrated that an integrated rehabilitation program administered over a 6-week after discharge in Lima, Peru was both feasible and acceptable, and had positive benefits on physical and pulmonary function and on mental health during the 12 weeks of follow-up. Measured improvements in the primary outcome of 6MWT distance recommend that we consider a phase III trial to test the efficacy of our integrated rehabilitation intervention in a larger sample.