MedTrace Logo

Effects of Mud Bath Therapy in Chronic Obstructive Pulmonary Disease

NCT01253941 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2013-09-13

No results posted yet for this study

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.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

OTHER

Mud bath Therapy

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

Sponsors & Collaborators

  • Fondazione Salvatore Maugeri

    lead OTHER

Principal Investigators

  • Simonetta Baldi, MD · Fondazione Salvatore Maugeri

  • Gian Domenico Pinna, Ph.D · Fondazione Salvatore Maugeri

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01253941 on ClinicalTrials.gov