Effects of Mud Bath Therapy in Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Simonetta Baldi, Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier:
NCT01253941
First received: December 2, 2010
Last updated: September 11, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease (COPD)
Other: Mud bath Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Mud Bath Therapy in Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by Fondazione Salvatore Maugeri:

Primary Outcome Measures:
  • Change from baseline in cytokine IL6 at 2weeks +2days (after Mud Bath Therapy) [ Time Frame: baseline test before IRB, at Day 17 ] [ Designated as safety issue: No ]
    Subjects for the study will be 42 mild-to-severe COPD outpatients. They will carry out baseline venous and arterial capillary blood sampling, ventilatory response tests and assessment of pulmonary function, before and after loaded breathing (IRB)test. Patients will then be randomized to standard mud bath therapy (12 sessions) or no-treatment. All tests and measurements will be repeated afterwards.

  • Change before-after IRB test in cytokine IL_6, at baseline [ Time Frame: before-after IRB test, at Day 0 ] [ Designated as safety issue: No ]
    Subjects for the study will be 42 mild-to-severe COPD outpatients. They will carry out baseline venous blood sampling, before and after loaded breathing (IRB)test. Change before-after IRB test in IL_6 will be assessed at baseline(day 0).

  • Change before-after IRB test in cytokine IL_6, at 2 weeks +2 days [ Time Frame: before-after IRB test, at Day 17 ] [ Designated as safety issue: No ]
    Subjects for the study will be 42 mild-to-severe COPD outpatients. They will carry out baseline venous blood sampling, before and after loaded breathing (IRB) test. Change before-after IRB test in IL_6 will be assessed again at 2 weeks + 2days(day 17, after Mud Bath Therapy).


Secondary Outcome Measures:
  • Change from baseline in respiratory muscle endurance time, at 2weeks +2days [ Time Frame: IRB test duration, at Day 17 ] [ Designated as safety issue: No ]
    Time duration of sustainable inspiratory pressure, set at 50% of MIP

  • Change from baseline in Ventilatory Response to CO2, at 2weeks +2days [ Time Frame: Baseline test at day 17 ] [ Designated as safety issue: No ]
    Ventilatory response to CO2 (VRCO2), is conducted according to Read's technique. The subjects will be seated comfortably, attached to the mouthpiece with a noseclip in place and breathing room air until the end-tidal PCO2 (Pet,CO2) stabilized. They then will start rebreathing a mixture of approximately 7% CO2 and 93% O2. Rebreathing was continued for at least 3 minutes.

  • Change before-after IRB test in VRCO2, at day 0 [ Time Frame: before-after IRB test, at Day 0 ] [ Designated as safety issue: No ]
    Ventilatory response to CO2 (VRCO2), conducted according to Read's technique, will be obtained before and after IRB test, at day 0

  • Change before-after IRB test in VRCO2, at day 17 [ Time Frame: before-after IRB test, at Day 17 ] [ Designated as safety issue: No ]
    Ventilatory response to CO2 (VRCO2), conducted according to Read's technique, will be obtained before and after IRB test, at day 17


Enrollment: 42
Study Start Date: June 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mud Bath therapy Other: Mud bath Therapy
patients will be randomized to Mud bath Therapy ( 12 sessions) or no treatment
Other Name: Thermal treatment
No Intervention: no 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.

  Eligibility

Ages Eligible for Study:   45 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01253941

Locations
Italy
Salvatore Maugeri Foundation - Scientific Institute of Montescano
Montescano, Pavia, Italy, 27047
Fondazione Salvatore Maugeri- Istituto Scientifico di Montescano
Montescano, Pavia, Italy, 27047
Sponsors and Collaborators
Fondazione Salvatore Maugeri
Investigators
Principal Investigator: Simonetta Baldi, MD Fondazione Salvatore Maugeri
Principal Investigator: Gian Domenico Pinna, Ph.D Fondazione Salvatore Maugeri
  More Information

Publications:
Responsible Party: Simonetta Baldi, Dr., Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier: NCT01253941     History of Changes
Other Study ID Numbers: MBT-COPD2010_FORSTIII, 1050 FoRST
Study First Received: December 2, 2010
Last Updated: September 11, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by Fondazione Salvatore Maugeri:
COPD, Intensive Resistive Breathing, Cytokine IL6,

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014