Clinical trial NCT06439875: Effects of L-arginine and Liposomial Vitamin C on Severe Copd Patients Undergoing Pulmonary Rehabilitation.
Official title: Effects of the Association of L-arginine and Liposomal Vitamin C on Fatigue in COPD Patients With Chronic Respiratory Failure After Rehabilitation Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Respiratory Failure
Keywords: COPD
pulmonary rehabilitation
L-arginine
fatigue
respiratory failure
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 102
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The primary objective of this project is to assess the effects of L-arginine plus Vitamin C supplementation on the physical outcomes in a group of COPD patients with chronic respiratory failure who underwent a 28-day PR program.

Eligible participants will be randomized using a random number generator in a 1:1 ratio to receive a twice-daily oral supplementation with either a combination of 1.66 g l-arginine plus 500 mg liposomal vitamin C (Bioarginina® C, Farmaceutici Damor, Naples, Italy) or a placebo for 28 days. Vials containing the active supplement or the placebo will be supplied by Farmaceutici Damor and will be made indistinguishable in appearance. All patients will undergo an intensive multidisciplinary PR program based on endurance and strength training. The main outcome of the study is the fatigue severity scale (FSS) total score after rehabilitation. Secondary outcomes include: 6-minute walking distance, forced expiratory volume in the first second (FEV1), COPD assessment test (CAT) score, endothelial function assessed through flow-mediated dilation (FMD), and muscular strength assessed through handgrip measurement.

Anthropometric, clinical, and functional characteristics of the study participants will be reported as mean ± standard deviation (SD) or median (interquartile range, IQR) for continuous variables and as absolute values (percentages) for categorical variables. Changes from baseline for continuous variables will be expressed as deltas (values at 28 days minus the values at baseline), and differences between the interventional groups will be evaluated using the Student's t-test for normally distributed variables or the Mann-Whitney U test for skewed variables.

Eligibility criteria: Inclusion criteria:

* 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 criteria:

* 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

Primary outcomes:
measure: Fatigue Severity Scale
timeFrame: at baseline and after 28 days of intensive pulmonary rehabilitation
Secondary outcomes:
measure: Six minute walking test (6MWT)
timeFrame: at baseline and after 28 days of intensive pulmonary rehabilitation
measure: Sit to stand test (STST)
timeFrame: at baseline and after 28 days of intensive pulmonary rehabilitation
measure: COPD Assessment Test (CAT)
timeFrame: at baseline and after 28 days of intensive pulmonary rehabilitation
measure: Medical Research Council (MRC) for dyspnea test
timeFrame: at baseline and after 28 days of intensive pulmonary rehabilitation
measure: Flow-mediated dilation (FMD);
timeFrame: at baseline and after 28 days of intensive pulmonary rehabilitation
measure: Fractional exhaled nitric oxide (FeNO)
timeFrame: at baseline and after 28 days of intensive pulmonary rehabilitation
measure: Muscle Strength
timeFrame: at baseline and after 28 days of intensive pulmonary rehabilitation
Other outcomes:
Locations:
city: Telese Terme
country: Italy
facility: Istituti Clinici Scientifici Maugeri
state: Benevento
Study officials:
affiliation: IRCCS Maugeri Telese
name: mauro maniscalco
role: PRINCIPAL_INVESTIGATOR
References: