Effects of L-arginine and Liposomial Vitamin C on Severe Copd Patients Undergoing Pulmonary Rehabilitation.

NCT06439875 | Completed

• 1 other identifier: CTSM109-23
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Obstructive Pulmonary Disease; Respiratory Failure

Keywords

COPD; pulmonary rehabilitation; L-arginine; fatigue; respiratory failure

Outcome Measures

Primary Outcomes (1)

• Fatigue Severity Scale

  The Fatigue Severity Scale (FSS) is a 9-item scale that measures the severity of fatigue and how much it affects the person's activities and lifestyle in patients with a variety of disorders. The items are scored on a 7 point scale with 1=strongly disagree and 7=strongly agree. The minimum score=9 and maximum score possible=63. Higher the score=greater fatigue severity. More common way of scoring: mean of all the scores with minimum score being 1 and maximum score being 7. Mean (SD) FSS scores for healthy individuals; 2.3 (0.7). Cut-off score of 4 or more considered indicative of problematic fatigue.

  at baseline and after 28 days of intensive pulmonary rehabilitation

Secondary Outcomes (7)

• Six minute walking test (6MWT)

  at baseline and after 28 days of intensive pulmonary rehabilitation

• Sit to stand test (STST)

  at baseline and after 28 days of intensive pulmonary rehabilitation

• COPD Assessment Test (CAT)

  at baseline and after 28 days of intensive pulmonary rehabilitation

• Medical Research Council (MRC) for dyspnea test

  at baseline and after 28 days of intensive pulmonary rehabilitation

• Flow-mediated dilation (FMD);

  at baseline and after 28 days of intensive pulmonary rehabilitation

Study Arms (2)

L-arginine (arm 1)

EXPERIMENTAL

Participants in this arm of the study will have an oral supplementation of l-arginine and liposomial vitamin C on a daily basis for 28 days.

Dietary Supplement: effect of L-arginine and liposomial vitamin C on pulmonary rehabilitation

Placebo (arm 2)

PLACEBO COMPARATOR

This arm will be given a placebo comparator on a daily basis for 28 days.

Other: placebo

Interventions

placebo OTHER

Patients in this arm will undergo multidisciplinary intensive pulmonary rehabilitation without any dietary supplementation.

Placebo (arm 2)

effect of L-arginine and liposomial vitamin C on pulmonary rehabilitation DIETARY_SUPPLEMENT

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

L-arginine (arm 1)

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead
• Azienda Ospedaliera dei Colli: collaborator
• Fondazione Don Carlo Gnocchi Onlus: collaborator

Study Sites (3)

Istituti Clinici Scientifici Maugeri Irccs

Telese Terme, Benevento, 82037, Italy

Location

Istituti Clinici Scientifici Maugeri IRCCS

Lumezzane, Brescia, 25065, Italy

Location

Istituti Clinici Scientifici Maugeri IRCCS

Bari, 70124, Italy

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency; Fatigue

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms

Study Officials

• mauro maniscalco

  IRCCS Maugeri Telese

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 3, 2024
• Study Start: July 16, 2024
• Primary Completion: February 16, 2026
• Study Completion: March 9, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)