Effects of Mud Bath Therapy in Chronic Obstructive Pulmonary Disease

NCT ID: NCT01253941

Last Updated: 2013-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2013-06-30

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD, Intensive Resistive Breathing, Cytokine IL6,

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Mud Bath therapy

Group Type: EXPERIMENTAL

Mud bath Therapy

Intervention Type: OTHER

patients will be randomized to Mud bath Therapy ( 12 sessions) or no treatment

no Mud Bath Therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mud bath Therapy

patients will be randomized to Mud bath Therapy ( 12 sessions) or no treatment

Intervention Type: OTHER

Other Intervention Names

Thermal treatment

Eligibility Criteria

Inclusion Criteria

• Age >/= 45 years
• 34% </= FEV1 </= 70%
• stable clinical conditions

Exclusion Criteria

• idiopathic or acquired bronchiectasis
• cardiovascular, peripheral vascular or cerebrovascular disease
• systemic confounding inflammatory disease (e.g rheumatoid arthritis,Crohn's disease, systemic vasculitis etc.)
• malignancies

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Salvatore Maugeri

OTHER

Sponsor Role: lead

Responsible Party

Simonetta Baldi

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simonetta Baldi, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Salvatore Maugeri

Gian Domenico Pinna, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Fondazione Salvatore Maugeri

Locations

Fondazione Salvatore Maugeri- Istituto Scientifico di Montescano

Montescano, Pavia, Italy

Salvatore Maugeri Foundation - Scientific Institute of Montescano

Montescano, Pavia, Italy

Countries

Italy

References

Vassilakopoulos T, Hussain SN. Ventilatory muscle activation and inflammation: cytokines, reactive oxygen species, and nitric oxide. J Appl Physiol (1985). 2007 Apr;102(4):1687-95. doi: 10.1152/japplphysiol.01273.2006. Epub 2006 Dec 21.

Reference Type: RESULT

PMID: 17185492 (View on PubMed)

Martyn JB, Moreno RH, Pare PD, Pardy RL. Measurement of inspiratory muscle performance with incremental threshold loading. Am Rev Respir Dis. 1987 Apr;135(4):919-23. doi: 10.1164/arrd.1987.135.4.919.

Reference Type: RESULT

PMID: 3565939 (View on PubMed)

Nickerson BG, Keens TG. Measuring ventilatory muscle endurance in humans as sustainable inspiratory pressure. J Appl Physiol Respir Environ Exerc Physiol. 1982 Mar;52(3):768-72. doi: 10.1152/jappl.1982.52.3.768.

Reference Type: RESULT

PMID: 7068493 (View on PubMed)

Baldi S, Pinna GD, Bruschi C, Caldara F, Maestri R, Dacosto E, Rezzani A, Popovich E, Bellinzona E, Crotti P, Montemartini S, Fracchia C. Medicinal clays improve the endurance of loaded inspiratory muscles in COPD: a randomized clinical trial of nonpharmacological treatment. Int J Chron Obstruct Pulmon Dis. 2015 Oct 23;10:2235-48. doi: 10.2147/COPD.S87999. eCollection 2015.

Reference Type: DERIVED

PMID: 26604728 (View on PubMed)

Baldi S, Jose PE, Bruschi C, Pinna GD, Maestri R, Rezzani A, Bellinzona E, Fracchia C, Dacosto E, Crotti P, Montemartini S. The mediating role of cytokine IL-6 on the relationship of FEV(1) upon 6-minute walk distance in chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2014 Oct 7;9:1091-9. doi: 10.2147/COPD.S57845. eCollection 2014.

Reference Type: DERIVED

PMID: 25336940 (View on PubMed)

Other Identifiers

1050 FoRST

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MBT-COPD2010_FORSTIII

Identifier Type: -

Identifier Source: org_study_id