Chronic Obstructive Pulmonary Disease (COPD)NCT01253941
Effects of Mud Bath Therapy in Chronic Obstructive Pulmonary Disease
A study testing Mud bath Therapy in people with Chronic Obstructive Pulmonary Disease (COPD), run by Fondazione Salvatore Maugeri at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Mud bath Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesItaly
- Study dates
- Jun 2010to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >/= 45 years
- 34% </= FEV1 </= 70%
- stable clinical conditions
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Fondazione Salvatore Maugeri- Istituto Scientifico di Montescano
Montescano, Pavia, 27047
Salvatore Maugeri Foundation - Scientific Institute of Montescano
Montescano, Pavia, 27047
About this study
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.
Read the 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.
- Being tested
- Mud bath Therapy
- Keywords
- COPD, Intensive Resistive Breathing, Cytokine IL6,
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mud bath TherapyOther
Also called Thermal treatment
patients will be randomized to Mud bath Therapy ( 12 sessions) or no treatment
| Study group | Role | What they receive |
|---|---|---|
| Mud Bath therapy | Experimental | Not described Receives: Other: Mud bath Therapy |
| no Mud Bath Therapy | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: before-after IRB test, at Day 17
Secondary outcomes (4)
Change from baseline in respiratory muscle endurance time, at 2weeks +2days
Time duration of sustainable inspiratory pressure, set at 50% of MIP
Measured: IRB test duration, at Day 17
Change from baseline in Ventilatory Response to CO2, at 2weeks +2days
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.
Measured: Baseline test at day 17
Change before-after IRB test in VRCO2, at day 0
Ventilatory response to CO2 (VRCO2), conducted according to Read's technique, will be obtained before and after IRB test, at day 0
Measured: before-after IRB test, at Day 0
Change before-after IRB test in VRCO2, at day 17
Ventilatory response to CO2 (VRCO2), conducted according to Read's technique, will be obtained before and after IRB test, at day 17
Measured: before-after IRB test, at Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Salvatore Maugeri
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simonetta Baldi, Fondazione Salvatore Maugeri
- Investigators
- Simonetta Baldi, MD, Principal investigator, Fondazione Salvatore MaugeriGian Domenico Pinna, Ph.D, Principal investigator, Fondazione Salvatore Maugeri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01253941
- Sponsor's protocol ID
- MBT-COPD2010_FORSTIII
- Other IDs
- 1050 FoRST
- Status last verified
- Sep 2013
- First submitted
- 2 Dec 2010
- Last updated
- 13 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17185492Martyn 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.
PubMed 3565939Nickerson 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.
PubMed 7068493Baldi 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.
PubMed 26604728Baldi 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.
PubMed 25336940
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mud Bath Therapy in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01253941
- Acronym / sponsor ID
- MBT-COPD2010_FORSTIII
- Keywords
- COPD, Intensive Resistive Breathing, Cytokine IL6,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Fondazione Salvatore MaugeriUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 6 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mud Bath therapy | Experimental | Other: Mud bath Therapy |
| no Mud Bath Therapy | No intervention | – |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >/= 45 years
- 34% </= FEV1 </= 70%
- stable clinical conditions
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mud bath TherapyAlso: Thermal treatmentpatients will be randomized to Mud bath Therapy ( 12 sessions) or no treatment | Other | Mud Bath therapy |
Primary outcome
Change from baseline in cytokine IL6 at 2weeks +2days (after Mud Bath Therapy)
Time frame: baseline test before IRB, at Day 17
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
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
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).
4 secondary outcomes
Change from baseline in respiratory muscle endurance time, at 2weeks +2days
Time frame: IRB test duration, at Day 17
Change from baseline in Ventilatory Response to CO2, at 2weeks +2days
Time frame: Baseline test at day 17
Change before-after IRB test in VRCO2, at day 0
Time frame: before-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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2013.
- Results publication: PubMed 17185492Vassilakopoulos 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.
- Results publication: PubMed 3565939Martyn 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.
- Results publication: PubMed 7068493Nickerson 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.
- Derived from this study: PubMed 26604728Baldi 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.
- Derived from this study: PubMed 25336940Baldi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simonetta Baldi, MD principal investigator
Fondazione Salvatore Maugeri
Gian Domenico Pinna, Ph.D principal investigator
Fondazione Salvatore Maugeri
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mud bath Therapy in people with Chronic Obstructive Pulmonary Disease (COPD), run by Fondazione Salvatore Maugeri at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in cytokine IL6 at 2weeks +2days (after Mud Bath Therapy) (time frame: baseline test before IRB, at Day 17). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01253941, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2013.