Effects of L-arginine and Liposomial Vitamin C on Severe Copd Patients Undergoing Pulmonary Rehabilitation.
Effects of the Association of L-arginine and Liposomal Vitamin C on Fatigue in COPD Patients With Chronic Respiratory Failure After Rehabilitation Intervention
Istituti Clinici Scientifici Maugeri SpA
102 participants
Jul 16, 2024
INTERVENTIONAL
Conditions
Summary
The hypothesis that is being tested is that the supplementation of L-arginine plus Vitamin C to multidisciplinary pulmonary rehabilitation (PR) in patients with a previous diagnosis of chronic obstructive pulmonary disease (COPD) and chronic respiratory failure can have a favorable influence on fatigue and on clinical indicators related to endothelial function, potentially mitigating the cardiovascular (CV) disease burden in this clinical context.
Eligibility
Inclusion Criteria2
- COPD patients of both sexes complicated by respiratory failure (PaO2 inferior to 60 mmHg while breathing room air)
- aged between 40 and 90 years selected from the inpatient/outpatient population admitted to perform a PR program in 12 Italian rehabilitation hospitals.
Exclusion Criteria13
- consuming any ergogenic supplement in the last 2 months;
- severe acute exacerbations in the 3 months before enrolment;
- clinical instability (pH inferior to 7.35, hemodynamic instability, tachypnea at rest);
- lung restrictive diseases;
- primitive pulmonary hypertension;
- recent lung thromboembolic events;
- orthopaedic clinical conditions interfering with exercise;
- coronary heart disease;
- cardiac failure with reduced ejection fraction;
- major cardiac arrhythmias;
- neuromuscular diseases;
- mini mental state examination (MMSE) \<24;
- any prior or current medical problem that would limit the subject participation
Interventions
Patients with a certified diagnosis of COPD and chronic respiratory failure will be randomized in a 1:1 ratio into the interventional arm or the placebo controller arm. All patients will undergo multidisciplinary intensive pulmonary rehabilitation for 28 days. The patients in the interventional group will receive a twice-daily oral supplementation with either a combination of 1.66 g l-arginine plus 500 mg liposomal vitamin C
Patients in this arm will undergo multidisciplinary intensive pulmonary rehabilitation without any dietary supplementation.
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT06439875