Physical activity coaching programme for people with Long COVID: a pilot randomised clinical trial
摘要
Low physical activity-PA may affect health outcomes in people with Long COVID. This study assessed the feasibility, safety and preliminary efficacy and effectiveness of a PA coaching programme vs. usual care. A randomised, parallel-group, pilot trial compared a twelve-week multicomponent PA coaching intervention (EG: self-monitoring, feedback, and goal setting/review) with usual care (CG: self-managed PA). PA (inertial sensors-light/moderate/vigorous PA [min·day-1], steps·day-1), functional capacity (6-minute walk test-6MWD; 1-minute sit-to-stand test-1minSTS), dyspnoea (modified Medical Research Council scale-mMRC), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue scale-FACIT-FS) and health-related quality of life-HRQoL (European Quality of Life-Five Dimensions-Five Levels visual analogue scale-EQ-5D-5L) were assessed at baseline, three- and six-months afterwards. Recruitment (≥70%), retention, adherence (≥80%) and preliminary efficacy/effectiveness explored feasibility. Adverse events determined safety. Fifty participants (EG: n=25, 47±10y, 80%♀; CG: n=25, 46±11y, 76%♀) were enrolled. Recruitment (89%), retention (92%) and adherence (83%) met feasibility criteria. At three-months, the EG improved PA, sedentary behaviour and functional capacity compared to the CG (light PA: +53[19;89]min·day-1; steps·day-1: +4632[2626;6638]; sedentary time: -71[-141;-2]min·day-1; 6MWD: +119[51;187]m). Dyspnoea, fatigue and HRQoL also improved (mMRC: -1[-2;-1]; FACIT-FS: +11[6;17]; EQ-5D-5L: +21[13;29]). These changes were maintained or further improved at six-months/three-months post-intervention (light PA: +73[36;111]min·day-1; moderate-to-vigorous PA: +7[1;14]min·day-1; steps·day-1: +5236[3070;7402]; sedentary time: -98[-165;-31]min·day-1; 6MWD: +136[69;203]m; 1minSTS: +9[2;15]reps; mMRC: -1[-2;-1]; FACIT-FS: +19[13;24]; EQ-5D-5L: +25[18;33]). No adverse events occurred. The PA coaching programme was feasible, safe and may enhance and sustain PA, sedentary behaviour, functional capacity, symptoms, and HRQoL in Long COVID up to three-months post-intervention. A large trial is warranted. ClinicalTrials.gov: NCT06165978