Trial reportPloS one2025
Is non-invasive ventilation effective in improving the exercise capacity in patients with cardiac heart failure?: A randomised crossover trial.
Trial report in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Is Non-invasive Ventilation Effective in Improving the Exercise Capacity in Patients With Cardiac Heart Failure?: A Randomized Controlled Trial
Effect of High-Flow Nasal Cannula Use on Exercise Tolerance and Physical Performance in Heart Failure Patients Enrolled in a Cardiac Rehabilitation Program: A Randomized Crossover Trial
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionHeart failure (HF) is a prevalent global health issue, characterized by the heart's inability to effectively pump or fill with blood, leading to inadequate cardiac output. Despite advances in medical treatments, exercise intolerance remains a significant challenge, impacting their quality of life and contributing to frequent hospitalizations. Recent studies suggest that non-invasive ventilation (NIV) may further enhance exercise performance by reducing ventilatory workload and fatigue. However, limited research has directly compared different ventilatory modes during exercise in patients with heart failure. This study aims to evaluate the effects of two NIV devices on exercise capacity.
methodsA randomised crossover trial was conducted in patients with HF, reduced ejection fraction (≤ 40%), New York Heart Association functional class I-III and clinically stable. All participants underwent an initial assessment followed by an incremental exercise test to determine maximum aerobic velocity. They were then randomized to perform three constant work rate tests on separate days under three conditions: (1) with Continuous Positive Airway Pressure (CPAP), (2) with pressure support (PS) and (3) without NIV. The primary outcome was time to exhaustion. Key physiological variables were recorded during each test. Participants were recruited and completed all testing between April 29 and July 18, 2022. ClinicalTrials.gov registration number: NCT05433610.
resultsA total of 11 patients (mean age: 67 ± 9.6 years) completed the study. Exercise duration was significantly longer in the pressure support group (9.8 ± 6.2 minutes) compared to the CPAP group (8.9 ± 6.0 minutes) and the control group (7.3 ± 6.2 minutes) (p = 0.043). No significant differences were found in average heart rate (HR), final HR, or oxygen saturation (SpO₂) between the groups (p > 0.05). Similarly, dyspnea and leg fatigue (modified Borg scale) showed no statistically significant differences between conditions (p > 0.05).
conclusionThe use of NIV, particularly the PS mode, during exercise significantly improved exercise duration in patients with HF compared to CPAP or no ventilatory support. CLINICAL
trial registrationClinicalTrials.gov Identifier: NCT05433610.
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