NCT04767126

Peripheral Muscle Function in Patients With COPD

Completed Last updated 22 March 2022

What this trial tests

trial in Copd in 20 participants. Completed in 30 November 2021.

Timeline

13 January 2021

Primary endpoint
30 November 2021

30 November 2021

Quick facts

Lead sponsor	Fondazione Don Carlo Gnocchi Onlus
Status	Completed
Study type	OBSERVATIONAL
Enrollment	20
Start date	13 January 2021
Primary completion	30 November 2021
Estimated completion	30 November 2021
Sites	1 location across Italy

Conditions studied

• Copd — all drugs for Copd →

Sponsor

Fondazione Don Carlo Gnocchi Onlus — full company profile →

Who can join

Adults 35 to 85, any sex, with Copd. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Chronic obstructive pulmonary disease (COPD) is characterized by irreversible airway obstruction and progressive deterioration of respiratory function. Patients with COPD show a limited exercise tolerance, early fatigability and progressive dyspnea, with important consequences on the ability to sustain even mild efforts and a drastic restriction in the activities of daily living. Muscle dysfunction is a systemic manifestation of COPD that contributes to exertion intolerance in individuals with COPD to the point of compromising fundamental functional activities, such as walking. Previous studies have shown, in fact, that quadriceps strength can be reduced by 20% to 30% in patients with COPD and this value is associated with an increased risk of mortality in patients with lower strength levels. In addition, loss of muscle mass or sarcopenia also occurs with a prevalence of between 8% and 67% in patients with COPD, exacerbating the picture of muscle dysfunction.

One of the goals of respiratory rehabilitation is precisely the prevention of muscle dysfunction in patients with COPD. However, rehabilitation programs aimed at maintaining and recovering muscle strength are often lacking in guidance regarding target muscles, duration of sessions, and training intensity, while strength assessment is often limited by the timing and resources associated with the clinical setting in which it takes place. This makes it difficult to determine its short- and long-term effectiveness.

Therefore, assessment of muscle function in patients with COPD requires tests that are simple and quick to perform, but equally capable of providing quantitative data referable to a specific characteristic of muscle strength as well as indicative of the patient's overall function. In addition, complementary measurements such as body composition and muscle mass, as well as the development of predictive models and normative values of muscle function could provide additional information on the progression of muscle dysfunction in patients with COPD, allowing rehabilitation intervention to be directed toward recovery of the most compromised functions.

Therefore, the aims of this study are: 1) To evaluate the effectiveness of a standard pulmonary rehabilitation program in recovering peripheral muscle dysfunction in patients with COPD. 2) To evaluate the clinical reliability of tests commonly used to measure peripheral muscle function in the rehabilitation setting of patients with COPD.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Muscle function and functional performance after pulmonary rehabilitation in patients with chronic obstructive pulmonary disease: a prospective observational study.
   Pancera S, Bianchi LNC, Porta R, Villafañe JH, et al · · 2022 · cited 4× · PMID 36180466 · DOI 10.1038/s41598-022-20746-y