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BronchiectasisNCT06002334

Relationship Between Nutritional State and Respiratory Muscle Weakness in Adult Patients With Bronchietasis

An observational study of Bronchiectasis, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To establish a relationship between malnutrion and respiratory muscle dysfunction in patients with bronchectasis Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bronchiectasis
How many people
100 participants
Where
1 siteEgypt
Study dates
23 Feb 2023to 15 Jun 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: adult patient with bronchectasis

Who may be able to join

  • Adult patients of both genders who have bronchiectasis based on imaging

Who cannot join

  • Patients less than 18 years old Patients with neuromuscular disorders, muscle dystrophies or other causes of muscle weakness

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of medicine, Assiut University

    Asyut

Other trials in Egypt

About this study

To establish a relationship between malnutrion and respiratory muscle dysfunction in patients with bronchectasis

Read the detailed description

Many different and prevalent chronic respiratory disorders, such as chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF), non-CF bronchiectasis, idiopathic pulmonary fibrosis (IPF) and lung cancer, not only target the lungs but are often associated with systemic manifestations (1-5). The latter can be magnified by the concomitant presence of aging, comorbidities or unhealthy lifestyle habits. Nutritional abnormalities stand out amongst the systemic manifestations present in chronic respiratory conditions. When these nutritional abnormalities become very severe, with marked weight and muscle mass loss, they constitute a complex metabolic syndrome, known as cachexia. However, it should be kept in mind that the earliest stages of nutritional abnormalities do not necessarily involve evident body weight loss. Diagnosis and stratification of patients with impaired nutritional status is important to decide the appropriate therapeutic approach. In fact, it has been clearly demonstrated that therapeutic interventions, even with only moderate increases in body weight or lean mass, can improve the prognosis of respiratory patients with nutritional abnormalities (6). Therefore, medical professionals should be able to detect these deficiencies early.

One of the most important clinical consequences of nutritional deficiencies in patients with chronic respiratory disorders is the loss of muscle mass and functional impairment (2,4,9). However, nutritional deficiencies not only affect muscle mass and function, but can also have a negative impact on bone and fat tissues, reaching a state of severe cachexia in the more advanced situations. Moreover, malnutrition also targets patient's immunocompetence, facilitating infections and exacerbations, which reciprocally will contribute to worsen nutritional status.

Muscle dysfunction is defined by the loss of strength (i.e., the ability to develop a maximal effort and/or endurance (i.e., the ability to maintain a submaximal effort through time) (10,11). This functional impairment can be relatively stable (this is known as 'muscle weakness') or temporary (denominated 'fatigue', which is reversible with rest) (10,11). Muscle dysfunction can involve peripheral (limb) as well as respiratory muscles, and can appear in acute or chronic respiratory diseases due to different causes. However, the loss of muscle mass is probably the main one, at least for limb muscles, having deleterious consequences on patients' prognosis (12,13). The term 'loss of muscle mass' is generally used to express a decrease in global muscle proportion or weight, but at a cellular level it actually indicates the loss of fibers or more frequently, a reduction in their size. The loss of muscle mass is mainly because of a decrease in muscle contractile protein content through different mechanisms, including the activation of the ubiquitin-proteasome system, autophagy and apoptosis (14). Global muscle mass and fiber size are the main factors contributing to muscle strength, although other components such as fiber type proportions and muscle length also play a relevant role (12). Therefore, a loss in either muscle mass or fiber atrophy will involve a decrease in contractile strength. On the other hand, endurance depends mostly on the muscle aerobic capacity, which in turn is a subrogate of the percentage of fibers with a predominant aerobic metabolism ('slow-twitch' fibers), capillary and mitochondrial density, and the capacity of oxidative enzymes on metabolic pathways (12).

The presence of limb muscle dysfunction can even limit normal walking, leading to a reduction of patient daily activities and social life, with a strong negative impact on prognosis, quality of life, and utilization of social and health resources (3,7,8,15-18). Respiratory muscle dysfunction in turn is associated with increased dyspnea (10,11,19), a worse ventilatory response to both exercise and exacerbations (19-21), and can even lead to severe respiratory failure, as well as weaning difficulties in patients submitted to mechanical ventilation (22,23).

Bronchiectasis, defined as the abnormal and irreversible dilation of the bronchi, are frequently observed even in general population, especially since the wide use of the high-resolution computed tomography (122). Although bronchiectasis can be the result of different processes, they are currently classified in those linked to CF and those that are independent of such a genetic alteration (non-CF), being the latter much more prevalent (123-125). Moreover, the above-mentioned advances in image techniques have allowed for the identification of a variable number of COPD patients who also have bronchiectasis to a greater or lesser extent (1). Although the most common clinical presentation of non-CF bronchiectasis is the presence of daily cough with abundant sputum and repeated infections (123,124), nutritional abnormalities are also frequent (2). Since many of the deleterious factors present in COPD are also present in non-CF bronchiectasis (local and systemic inflammation, exacerbations, ventilatory limitation, deconditioning, etc.) (126,127), it could be speculated that muscle dysfunction would also be frequent in this case. However, the actual prevalence of this disorder in non-CF bronchiectasis remains unclear. Respiratory muscle dysfunction has only been occasionally described in this lung disease (2,126,128,129) and, so far little attention has been given to the eventual presence of limb muscle malfunctioning. In fact, only isolated reports suggest that this latter abnormality is common in non-CF bronchiectasis (130,131) and exercise tolerance can also be reduced (126).

Conditions
Bronchiectasis
Medical subject headings
Bronchiectasis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To establish a relationship between malnutrion and respiratory muscle dysfunction in patients with bronchectasis

    To establish a relationship between malnutrion and respiratory muscle dysfunction in patients with bronchectasis

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2023
  2. Study start23 Feb 2023
  3. Primary completion23 Apr 2024 (estimated)
  4. Study completion15 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06002334
Sponsor's protocol ID
muscle weaknessinbroncheactsis
Status last verified
Aug 2023
First submitted
13 Aug 2023
Last updated
21 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Bronchiectasis, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To establish a relationship between malnutrion and respiratory muscle dysfunction in patients with bronchectasis (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.

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