Effects of L-arginine and Vitamin C on COPD patients in rehabilitation

Effects of the Association of L-arginine and Liposomal Vitamin C on Fatigue in COPD Patients With Chronic Respiratory Failure After Rehabilitation Intervention

This study is testing if taking L-arginine and Vitamin C can help people with COPD feel less tired and improve their overall health during a 28-day rehab program.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 102 (estimated)
• Ages: 40 Years to 90 Years
• Sex: All
• Sponsor: Istituti Clinici Scientifici Maugeri SpA (Academic / other)
• Locations: 1 site (Telese Terme, Benevento)
• Trial ID: NCT06439875 on ClinicalTrials.gov

What this trial studies

This study investigates the impact of L-arginine and liposomal Vitamin C supplementation on patients with chronic obstructive pulmonary disease (COPD) and chronic respiratory failure undergoing a 28-day pulmonary rehabilitation program. Participants will be randomly assigned to receive either the active supplement or a placebo, with the primary focus on measuring changes in fatigue severity and various clinical indicators. Secondary outcomes will include assessments of walking distance, lung function, and muscular strength. The goal is to determine if these supplements can improve physical outcomes and reduce cardiovascular disease burden in this patient population.

Who should consider this trial

Good fit: Ideal candidates are COPD patients aged 40 to 90 years with chronic respiratory failure who are participating in a pulmonary rehabilitation program.

Not a fit: Patients with severe acute exacerbations, significant cardiac issues, or other conditions that limit participation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the quality of life and physical capabilities of COPD patients undergoing rehabilitation.

How similar studies have performed: While the specific combination of L-arginine and Vitamin C in this context is novel, previous studies have shown potential benefits of similar interventions in related conditions.

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

Where this trial is running

Telese Terme, Benevento

• Istituti Clinici Scientifici Maugeri — Telese Terme, Benevento, Italy (Recruiting)

Study contacts

• Principal investigator: mauro maniscalco — IRCCS Maugeri Telese
• Study coordinator: Mauro Maniscalco

Conditions Chronic Obstructive Pulmonary Disease; Respiratory Failure; COPD; pulmonary rehabilitation; L-arginine; fatigue; respiratory failure