Peripheral Muscle Function in Patients With COPD

Sponsor
Fondazione Don Carlo Gnocchi Onlus (Other)
Overall Status
Completed
CT.gov ID
NCT04767126
Collaborator
(none)
20
1
10.5
1.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Impact of Pulmonary Rehabilitation on Peripheral Skeletal Muscle Function in Patients With Chronic Obstructive Pulmonary Disease.
    Actual Study Start Date :
    Jan 13, 2021
    Actual Primary Completion Date :
    Nov 30, 2021
    Actual Study Completion Date :
    Nov 30, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Lower limbs muscle power [Change from baseline through study completion, an average of 6 weeks]

      Muscle power of the lower limbs measured during the sit-to-stand test

    2. Lower limbs muscle power [Change after 3 months from study completion]

      Muscle power of the lower limbs measured during the sit-to-stand test

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • COPD diagnosis (GOLD stage: II-III-IV), defined as post-bronchodilator forced expiratory volume in 1s (FEV1)/forced vital capacity < 0.7 and FEV1 < 80% predicted.
    Exclusion Criteria:
    • Restrictive lung disease, unstable conditions, recent exacerbation, infection, embolism, pneumothorax, thoracic or abdominal surgery (less than 3 months before recruitment).

    • Cardiologic conditions like myocardial infarction (less than 6 months before recruitment), heart failure, or severe angina.

    • Inability of perform the exercise training (e.g. orthopaedic conditions).

    • Incapability to understand the instructions required to carry out the tests and assessments planned.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IRCCS Fondazione Don Carlo Gnocchi Milan Italy 20100

    Sponsors and Collaborators

    • Fondazione Don Carlo Gnocchi Onlus

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Simone Pancera, PhD(s), Fondazione Don Carlo Gnocchi Onlus
    ClinicalTrials.gov Identifier:
    NCT04767126
    Other Study ID Numbers:
    • MAC_COPD_FDG
    First Posted:
    Feb 23, 2021
    Last Update Posted:
    Mar 22, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Simone Pancera, PhD(s), Fondazione Don Carlo Gnocchi Onlus

    Study Results

    No Results Posted as of Mar 22, 2022