Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
Effects of Mud Bath Therapy in Chronic Obstructive Pulmonary Disease
Rehabilitation and physical therapy strategies targeting extra pulmonary manifestations of
Chronic Obstructive Pulmonary Disease (COPD)are far from being well defined. Studies,
performed in healthy subjects using threshold breathing device [a simple method to increase
inspiratory muscle load] have shown that ventilatory muscle overactivation during loaded
breathing may prime reactive oxygen species (ROS) production, thus initiating an
inflammatory response that results in elevation of pro-inflammatory cytokines, particularly
IL_6. Increase of cytokine IL_6 in turn, elicits a cascade of systemic responses, involving
hormone like glucoregulatory mechanisms, lipolysis and fat oxidation, as well as control of
breathing.
Thermal mud bath therapy has been acknowledged for its antioxidant and anti-inflammatory
effects in several chronic diseases. However, it is not considered among treatment options
of chronic pulmonary disease. Previous experimental studies indicate that trace elements of
thermal treatments, particularly iodide and bromide, may positively intervene in the setup
and maintenance of active state in skeletal muscle. These findings suggest that in COPD
patients these elements may improve the loading and endurance of respiratory muscles and
therefore blunt ventilatory muscle overactivation and the ensuing inflammatory cytokine
response.
In this study the investigators want to test two major hypotheses. First, that mud bath
therapy reduces systemic inflammatory processes in COPD patients, increases respiratory
muscle endurance and normalizes the ventilatory response. Second, that the increase in
systemic inflammation after IRB exercise is blunted by mud bath therapy.
The impact of extra pulmonary manifestations of Chronic Obstructive Pulmonary Disease (COPD)
on physical performance and quality of life, together with the notion that plasma cytokines
in COPD is not due to an overflow of inflammatory mediators from the lung compartment, raise
interest in understanding the potential link between lung and systemic inflammation.
Recent studies, performed in normal subjects using threshold breathing device [a simple
method to increase respiratory resistance and inspiratory muscle load] have shown that
ventilatory muscle activation during loaded breathing may prime reactive oxygen species
(ROS) production, thus initiating an inflammatory response within diaphragm that results in
systemic elevation of pro-inflammatory cytokines. These findings provide a sound working
hypothesis about the origin of systemic inflammation in COPD. Endurance and task failure of
inspiratory muscles can be challenged during inspiratory resistive breathing (IRB) exercise
performed with either nonlinear or threshold loading devices [4-6], thus allowing to
simulate resistive breathing caused by airway narrowing occurring during COPD exacerbations
Therapy with mineral water is a widely used modality of physical therapy in countries rich
in mineral water. Up to date, however, it is not considered among treatment options of
chronic pulmonary disease by recent guidelines. Mud bath therapy has been acknowledged for
its antioxidant and anti-inflammatory effects in several chronic diseases. Although full
mechanisms of such effects have not yet been fully elucidated, previous in vivo studies on
the effects of several anions on the duration of active state in skeletal muscle indicate
that trace elements of thermal treatments, particularly iodide and bromide, may positively
intervene in the setup and maintenance of this active state. These findings suggest that in
COPD patients these elements may improve the loading and endurance of respiratory muscles
and therefore blunt ventilatory muscle overactivation and the ensuing inflammatory cytokine
response.
In this study the investigators want to test two major hypotheses. First, that mud bath
therapy reduces systemic inflammatory processes in COPD patients, increases respiratory
muscle endurance and normalizes the ventilatory response. Second, that the increase in
systemic inflammation after IRB exercise is blunted by mud bath therapy.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
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