Effects of Mud Bath Therapy in Chronic Obstructive Pulmonary Disease

NCT01253941 | Completed DMC

• 2 other identifiers: MBT-COPD2010_FORSTIII1050 FoRST
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD, Intensive Resistive Breathing, Cytokine IL6,

Outcome Measures

Primary Outcomes (3)

• Change from baseline in cytokine IL6 at 2weeks +2days (after Mud Bath Therapy)

  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.

  baseline test before IRB, at Day 17

• Change before-after IRB test in cytokine IL_6, at baseline

  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).

  before-after IRB test, at Day 0

• Change before-after IRB test in cytokine IL_6, at 2 weeks +2 days

  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).

  before-after IRB test, at Day 17

Secondary Outcomes (4)

• Change from baseline in respiratory muscle endurance time, at 2weeks +2days

  IRB test duration, at Day 17

• Change from baseline in Ventilatory Response to CO2, at 2weeks +2days

  Baseline test at day 17

• Change before-after IRB test in VRCO2, at day 0

  before-after IRB test, at Day 0

• Change before-after IRB test in VRCO2, at day 17

  before-after IRB test, at Day 17

Study Arms (2)

Mud Bath therapy

EXPERIMENTAL

Other: Mud bath Therapy

no Mud Bath Therapy

NO INTERVENTION

Interventions

Mud bath Therapy OTHER

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

Also known as: Thermal treatment

Mud Bath therapy

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Salvatore Maugeri: lead

Study Sites (2)

Fondazione Salvatore Maugeri- Istituto Scientifico di Montescano

Montescano, Pavia, 27047, Italy

Location

Salvatore Maugeri Foundation - Scientific Institute of Montescano

Montescano, Pavia, 27047, Italy

Location

Related Publications (5)

• 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.

  PMID: 17185492 RESULT

• 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.

  PMID: 3565939 RESULT

• 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.

  PMID: 7068493 RESULT

• 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.

  PMID: 26604728 DERIVED

• 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.

  PMID: 25336940 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Mud Therapy

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Balneology; Therapeutics

Study Officials

• Simonetta Baldi, MD

  Fondazione Salvatore Maugeri

  PRINCIPAL INVESTIGATOR

• Gian Domenico Pinna, Ph.D

  Fondazione Salvatore Maugeri

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 2, 2010
• First Posted: December 6, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: September 13, 2013

Record last verified: 2013-09

Locations

IT (2)