Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06002334 |
| Other study ID # |
muscle weaknessinbroncheactsis |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 23, 2023 |
| Est. completion date |
June 15, 2024 |
Study information
| Verified date |
August 2023 |
| Source |
Assiut University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
To establish a relationship between malnutrion and respiratory muscle dysfunction in patients
with bronchectasis
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).
