Effects of Mud Bath Therapy in Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Mud bath Therapy
Intervention type(s): Other
Intervention description(s): patients will be randomized to Mud bath Therapy ( 12 sessions) or no treatment
Other intervention name(s): Thermal treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD, Intensive Resistive Breathing, Cytokine IL6,