Background: <p>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.</p> Methods: <p>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 (<i>n</i> = 33) or PMT (<i>n</i> = 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.</p> Results: <p>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.</p> Conclusions: <p>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.</p>

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Increased physical performance after personalised physiotherapy and nutritional counselling in adults with post-COVID-19 condition: a feasibility randomised trial

  • Berenice G. Jimenez Garcia,
  • Stijn Roggeman,
  • Lynn Leemans,
  • Wilfried Cools,
  • David Beckwée,
  • Elisabeth De Waele

摘要

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.