Dietary nitrate supplementation for preventing and reducing the severity of winter infections, including COVID-19, in care homes (BEET-Winter): a randomised placebo-controlled feasibility trial.

PURPOSE: Infections cause considerable care home morbidity and mortality. Nitric oxide (NO) has broad-spectrum anti-viral, bacterial and yeast activity in vitro. We assessed the feasibility of supplementing dietary nitrate (NO substrate) intake in care home residents. METHODS: We performed a cluster-randomised placebo-controlled trial in UK residential and nursing care home residents and compared nitrate containing (400 mg) versus free (0 mg daily) beetroot juice given for 60 days. Outcomes comprised feasibility of recruitment, adherence, salivary and urinary nitrate, and ordinal infection/clinical events. RESULTS: Of 30 targeted care homes in late 2020, 16 expressed interest and only 6 participated. 49 residents were recruited (median 8 [interquartile range 7-12] per home), mean (standard deviation) age 82 (8) years, with proxy consent 41 (84%), advance directive for hospital non-admission 8 (16%) and ≥ 1 doses of COVID-19 vaccine 37 (82%). Background dietary nitrate was < 30% of acceptable daily intake. 34 (76%) residents received > 50% of juice. Residents randomised to nitrate vs placebo had higher urinary nitrate levels, median 50 [18-175] v 18 [10-50] mg/L, difference 25 [0-90]. Data paucity precluded clinical between-group comparisons; the outcome distribution was as follows: no infection 32 (67%), uncomplicated infection 0, infection requiring healthcare support 11 (23%), all-cause hospitalisation 5 (10%), all-cause mortality 0. Urinary tract infections were most common. CONCLUSIONS: Recruiting UK care homes during the COVID-19 pandemic was partially successful. Supplemented dietary nitrate was tolerated and elevated urinary nitrate. Together, infections, hospitalisations and deaths occurred in 33% of residents over 60 days. A larger trial is now required. TRIAL REGISTRATION: ISRCTN51124684. Application date 7/12/2020; assignment date 13/1/2021.

The feasibility and tolerability of using inspiratory muscle training with adults discharged from the hospital with community-acquired pneumonia.

INTRODUCTION: Patients experience substantial morbidity following discharge from hospital and during recovery from communi-ty-acquired pneumonia (CAP). Inspiratory muscle training (IMT) has demonstrated improved functional capacity and reduced patient-reported symptoms. To date the safety and tolerability of these methods have not been determined in CAP patients recovering following hospitalization. Accordingly, this study aimed to assess the safety and tolerability of IMT in adults discharged from hospital with CAP. MATERIAL AND METHODS: Participants received an IMT device (POWERbreathe KHP2) and completed 9-weeks IMT training with weekly follow-up. Frequency (twice daily) and load (50% PImax) were fixed throughout, but training volume increased incrementally (2-week habituation phase, 7-week training phase). Primary outcomes of interest included IMT safety and tolerability. RESULTS: Twenty-two participants were recruited; 16 were male, mean age 55.2 years (range 27.9-77.3). From 1183 possible training days, side effects were reported on 15 occasions by 10 individual participants. All reported side-effects were assessed as grade 1 and did not prevent further training. Participant-reported IMT acceptability was 99.4%. CONCLUSION: Inspiratory muscle training is safe and tolerable in patients following hospitalisation for CAP. Patient satisfaction with IMT is high and it is viewed by patients as being helpful in their recovery. Distinguishing CAP-related symptoms and device-related side effects is challenging. Symptom prevalence declined during follow-up with concurrent improvements in spirometry observed. Further research is required to determine the efficacy of IMT interventions following CAP and other acute respiratory infections.