Increased physical performance after personalised physiotherapy and nutritional counselling in adults with
Berenice G Jimenez Garcia1,2,3, Stijn Roggeman4, Lynn Leemans5,6,7
1Metabolism and Nutrition (MeNu) Research Unit, Vitality Research Group, Vrije Universiteit Brussel (VUB), Laarbeeklaan 103, 1090, Brussels, Belgium. berenice.gabriela.jimenez.garcia@vub.be.
Background:
Nutritional counselling and physiotherapy could provide synergistic effects in alleviating Post-COVID-19 Condition (PCC) symptoms. However, the feasibility of such personalised multimodal therapy (PMT) remains unclear. The aim was to examine feasibility and inform a future randomised controlled trial (RCT) by exploring preliminary clinical outcomes.
Methods:
This pilot and feasibility parallel-group RCT was conducted at a tertiary hospital (ClinicalTrials.gov: NCT05254301, KCE-trials funding: LCOV-211306). Adult participants with PCC according to the WHO criteria were block-randomised into either physiotherapy (n = 33) or PMT (n = 32) for 12 weeks with 6-week follow-up. The PMT included online nutritional counselling and pacing-based physiotherapy. Outcome assessment was assessor-blinded. Feasibility outcomes included study burden, recruitment, and attrition. The 1-min sit-to-stand test (1-MSTS) was assessed as an exploratory clinical outcome. Descriptive statistics and 95% confidence intervals (95% CI) were used to estimate between-group differences. Analyses used all available data, with varying sample sizes.
Results:
Here we show that study burden was higher than expected, affecting both recruitment and attrition. The PMT group attended 10 ± 4 dietitian teleconsultations and 14 ± 4 supervised physiotherapy sessions. Between-group mean differences in 1-MSTS repetitions from baseline were 0.97 [95% CI: -1.75, 3.70] at 12 weeks and 2.14 [95% CI: -1.26, 5.54] at follow-up. A definitive RCT would require 41 participants.
Conclusions:
The study demonstrated overall safety and feasibility despite a high study burden. Exploratory clinical outcomes showed potential improvement in both groups, with growing estimated differences between groups over time, suggesting a longer follow-up for a definitive RCT.
