Chronic Obstructive Pulmonary DiseaseNCT01556139
Effectiveness of Respiratory Muscle Training by Spirotiger in Chronic Patients
A study testing Spirotiger in people with Chronic Obstructive Pulmonary Disease and Congestive Heart Failure, run by Fondazione Salvatore Maugeri at 1 site in Italy.
Trial summary
The reduction in effort tolerance as result of a decreased efficiency in ventilation is common both in patients affected by COPD (McKenzie) and chronic heart failure (CHF) (Ribeiro, Frankenstein). One of the most common cause is the reduced respiratory muscle strength and endurance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Congestive Heart Failure
- What is being tested?
- Spirotiger
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2011to Feb 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to perform 6-min walking test.
- Emogas analysis at rest (with PaO2>60mmHg and PCO2<45 mmHg)
- Mini Mental State Examination (MMSE) > 25
- Absence of major events in the last month (i.e. respiratory exacerbation treated with antibiotic therapy, CHF unstabilization with administration of vasopressor drugs to support the cardiac pump).
- Maximum Voluntary Ventilation (MVV) as evaluation of endurance <90%.
Who cannot join
- Haemodynamic instability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effectiveness of Respiratory Muscle Training by the Technique of Hypocapnia Hyperpnea (Spirotiger) in COPD and CHF Patients
The reduction in effort tolerance as result of a decreased efficiency in ventilation is common both in patients affected by COPD (McKenzie) and chronic heart failure (CHF) (Ribeiro, Frankenstein). One of the most common cause is the reduced respiratory muscle strength and endurance. Some studies have evaluated the effect of a specific training on the muscular strength both in pulmonary (Battaglia, Powell) and cardiac patients (Winkelmann, Chiappa). Moreover, only few studies investigated a specific training for such patients (Koppers, Sherer) because of the complicated equipment needed to prevent hypocapnia. Up to date, portable and economic systems for isocapnic hyperpnea have been developed for respiratory muscle training.
Primary aim of the study was to evaluate the effectiveness of the respiratory muscle training -by the technique of the isocapnic hyperpnea- on the effort tolerance and endurance in patients with COPD and CHF
Secondary aims were: A.to quantify the number of patients with deficit of respiratory muscles endurance and B.to verify different response of training between COPD and CHF patients
Read the detailed description
All consecutive stable patients with diagnosis of COPD or CHF and normal MMSE, admitted in Foundation S. Maugeri in Lumezzane (Brescia, Italy) for routinary rehabilitation at Respiratory and Cardiac Rehabilitative Divisions are enrolled.
All patients who met the inclusion criteria (see above)are informed about the aim of the project, sign an informed consent and are enrolled in the study.
40 patients are enrolled. They are divided in two groups of 20 each (10 cardiac and 10 respiratory patients) named:
- Spirotiger Group: these patients perform 20 sessions of usual training (cyclette and calisthenic exercises) and specific training (further 20 sessions) for respiratory muscles with SPIROTIGER
- Control Group: these patients perform 20 sessions of usual training (cyclette and calisthenic exercises) and additional 20 sessions with a placebo device (Threshold)
- Being tested
- Spirotiger
- Keywords
- Endurance, exercise training, 6-min walking test
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpirotigerDevice
The Training group perform 20 sessions of a specific training with Spirotiger, a device allowing respiratory muscle training with isocapnic hyperpnea.
The setting is the following:
- volume/size of the breathing bag: 50% of the vital capacity (VC) and ventilation (VE= Tidal volume x respiratory rate) at 66% of the MVV aiming to reach 15 minutes of training without breaks. During the initial sessions, the patient can interrupt training every 5 minutes and recover.
- increase in training: after 15 minutes of exercise VE is increased up to 75% of the MVV through modification of the volume of breathing bag or respiratory rate.
At the end of 15 minutes of exercise, further increases in ventilation are 10% of each previous step.
| Study group | Role | What they receive |
|---|---|---|
| Spirotiger | Experimental | Patients belonging to this group perform 20 sessions of usual training (cyclette and calisthenic exercises) and additional 20 sessions of a specific training for respiratory muscles with Spirotiger Receives: Device: Spirotiger |
| Control | No intervention | Control group with a placebo device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in MVV
In patients with COPD and CHF,endurance is measured by Maximum Voluntary Ventilation Test (MVV)
Measured: baseline and 20 days
Secondary outcomes (2)
Changes in 6-min Walking test
Measured: baseline and 20 days
Changes in Spirometry parameters
Measured: baseline and 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startJun 2011
- Primary completionNov 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Salvatore Maugeri
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mara Paneroni, Fondazione Salvatore Maugeri
- Investigators
- Mara Paneroni, PT, Principal investigator, Fondazione Salvatore Maugeri, Lumezzzane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556139
- Sponsor's protocol ID
- Spirotiger
- Status last verified
- Mar 2022
- First submitted
- 7 Mar 2012
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Publication
Publications
Ribeiro JP, Chiappa GR, Neder JA, Frankenstein L. Respiratory muscle function and exercise intolerance in heart failure. Curr Heart Fail Rep. 2009 Jun;6(2):95-101. doi: 10.1007/s11897-009-0015-7.
PubMed 19486593Frankenstein L, Nelles M, Meyer FJ, Sigg C, Schellberg D, Remppis BA, Katus HA, Zugck C. Validity, prognostic value and optimal cutoff of respiratory muscle strength in patients with chronic heart failure changes with beta-blocker treatment. Eur J Cardiovasc Prev Rehabil. 2009 Aug;16(4):424-9. doi: 10.1097/HJR.0b013e3283030a7e.
PubMed 19474739Battaglia E, Fulgenzi A, Ferrero ME. Rationale of the combined use of inspiratory and expiratory devices in improving maximal inspiratory pressure and maximal expiratory pressure of patients with chronic obstructive pulmonary disease. Arch Phys Med Rehabil. 2009 Jun;90(6):913-8. doi: 10.1016/j.apmr.2008.12.019.
PubMed 19480865Powell T, Williams EM. Inspiratory muscle training in adults with COPD. Respir Med. 2009 Aug;103(8):1239; author reply 1240-1. doi: 10.1016/j.rmed.2009.01.027. Epub 2009 Apr 11. No abstract available.
PubMed 19362808Winkelmann ER, Chiappa GR, Lima CO, Viecili PR, Stein R, Ribeiro JP. Addition of inspiratory muscle training to aerobic training improves cardiorespiratory responses to exercise in patients with heart failure and inspiratory muscle weakness. Am Heart J. 2009 Nov;158(5):768.e1-7. doi: 10.1016/j.ahj.2009.09.005. Epub 2009 Oct 2.
PubMed 19853695Chiappa GR, Roseguini BT, Vieira PJ, Alves CN, Tavares A, Winkelmann ER, Ferlin EL, Stein R, Ribeiro JP. Inspiratory muscle training improves blood flow to resting and exercising limbs in patients with chronic heart failure. J Am Coll Cardiol. 2008 Apr 29;51(17):1663-71. doi: 10.1016/j.jacc.2007.12.045.
PubMed 18436118Koppers RJ, Vos PJ, Boot CR, Folgering HT. Exercise performance improves in patients with COPD due to respiratory muscle endurance training. Chest. 2006 Apr;129(4):886-92. doi: 10.1378/chest.129.4.886.
PubMed 16608934Scherer TA, Spengler CM, Owassapian D, Imhof E, Boutellier U. Respiratory muscle endurance training in chronic obstructive pulmonary disease: impact on exercise capacity, dyspnea, and quality of life. Am J Respir Crit Care Med. 2000 Nov;162(5):1709-14. doi: 10.1164/ajrccm.162.5.9912026.
PubMed 11069801McKenzie DK, Butler JE, Gandevia SC. Respiratory muscle function and activation in chronic obstructive pulmonary disease. J Appl Physiol (1985). 2009 Aug;107(2):621-9. doi: 10.1152/japplphysiol.00163.2009. Epub 2009 Apr 23.
PubMed 19390004Paneroni M, Simonelli C, Saleri M, Trainini D, Fokom G, Speltoni I, Piaggi G, Ambrosino N, Vitacca M. Short-Term Effects of Normocapnic Hyperpnea and Exercise Training in Patients With Chronic Obstructive Pulmonary Disease: A Pilot Study. Am J Phys Med Rehabil. 2018 Dec;97(12):866-872. doi: 10.1097/PHM.0000000000000988.
PubMed 29927750
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Respiratory Muscle Training by the Technique of Hypocapnia Hyperpnea (Spirotiger) in COPD and CHF Patients
- ClinicalTrials.gov ID
- NCT01556139
- Acronym / sponsor ID
- Spirotiger
- Keywords
- Endurance, exercise training, 6-min walking test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fondazione Salvatore MaugeriUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Nov 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 16 Mar 2012 (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.
The reduction in effort tolerance as result of a decreased efficiency in ventilation is common both in patients affected by COPD (McKenzie) and chronic heart failure (CHF) (Ribeiro, Frankenstein). One of the most common cause is the reduced respiratory muscle strength and endurance. Some studies have evaluated the effect of a specific training on the muscular strength both in pulmonary (Battaglia, Powell) and cardiac patients (Winkelmann, Chiappa). Moreover, only few studies investigated a specific training for such patients (Koppers, Sherer) because of the complicated equipment needed to prevent hypocapnia. Up to date, portable and economic systems for isocapnic hyperpnea have been developed for respiratory muscle training.
Primary aim of the study was to evaluate the effectiveness of the respiratory muscle training -by the technique of the isocapnic hyperpnea- on the effort tolerance and endurance in patients with COPD and CHF
Secondary aims were: A.to quantify the number of patients with deficit of respiratory muscles endurance and B.to verify different response of training between COPD and CHF patients
Detailed description
All consecutive stable patients with diagnosis of COPD or CHF and normal MMSE, admitted in Foundation S. Maugeri in Lumezzane (Brescia, Italy) for routinary rehabilitation at Respiratory and Cardiac Rehabilitative Divisions are enrolled.
All patients who met the inclusion criteria (see above)are informed about the aim of the project, sign an informed consent and are enrolled in the study.
40 patients are enrolled. They are divided in two groups of 20 each (10 cardiac and 10 respiratory patients) named:
- Spirotiger Group: these patients perform 20 sessions of usual training (cyclette and calisthenic exercises) and specific training (further 20 sessions) for respiratory muscles with SPIROTIGER
- Control Group: these patients perform 20 sessions of usual training (cyclette and calisthenic exercises) and additional 20 sessions with a placebo device (Threshold)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spirotiger | Experimental | Device: SpirotigerPatients belonging to this group perform 20 sessions of usual training (cyclette and calisthenic exercises) and additional 20 sessions of a specific training for respiratory muscles with Spirotiger |
| Control | No intervention | –Control group with a placebo device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ability to perform 6-min walking test.
- Emogas analysis at rest (with PaO2>60mmHg and PCO2<45 mmHg)
- Mini Mental State Examination (MMSE) > 25
- Absence of major events in the last month (i.e. respiratory exacerbation treated with antibiotic therapy, CHF unstabilization with administration of vasopressor drugs to support the cardiac pump).
- Maximum Voluntary Ventilation (MVV) as evaluation of endurance <90%.
Key exclusion criteria (1 listed)
- Haemodynamic instability
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 |
|---|---|---|
| SpirotigerThe Training group perform 20 sessions of a specific training with Spirotiger, a device allowing respiratory muscle training with isocapnic hyperpnea. The setting is the following: * volume/size of the breathing bag: 50% of the vital capacity (VC) and ventilation (VE= Tidal volume x respiratory rate) at 66% of the MVV aiming to reach 15 minutes of training without breaks. During the initial sessions, the patient can interrupt training every 5 minutes and recover. * increase in training: after 15 minutes of exercise VE is increased up to 75% of the MVV through modification of the volume of breathing bag or respiratory rate. At the end of 15 minutes of exercise, further increases in ventilation are 10% of each previous step. | Device | Spirotiger |
Primary outcome
Changes in MVV
Time frame: baseline and 20 days
In patients with COPD and CHF,endurance is measured by Maximum Voluntary Ventilation Test (MVV)
2 secondary outcomes
Changes in 6-min Walking test
Time frame: baseline and 20 days
Changes in Spirometry parameters
Time frame: baseline and 20 days
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 31 Mar 2022.
- Background: PubMed 19486593Ribeiro JP, Chiappa GR, Neder JA, Frankenstein L. Respiratory muscle function and exercise intolerance in heart failure. Curr Heart Fail Rep. 2009 Jun;6(2):95-101. doi: 10.1007/s11897-009-0015-7.
- Background: PubMed 19474739Frankenstein L, Nelles M, Meyer FJ, Sigg C, Schellberg D, Remppis BA, Katus HA, Zugck C. Validity, prognostic value and optimal cutoff of respiratory muscle strength in patients with chronic heart failure changes with beta-blocker treatment. Eur J Cardiovasc Prev Rehabil. 2009 Aug;16(4):424-9. doi: 10.1097/HJR.0b013e3283030a7e.
- Background: PubMed 19480865Battaglia E, Fulgenzi A, Ferrero ME. Rationale of the combined use of inspiratory and expiratory devices in improving maximal inspiratory pressure and maximal expiratory pressure of patients with chronic obstructive pulmonary disease. Arch Phys Med Rehabil. 2009 Jun;90(6):913-8. doi: 10.1016/j.apmr.2008.12.019.
- Background: PubMed 19362808Powell T, Williams EM. Inspiratory muscle training in adults with COPD. Respir Med. 2009 Aug;103(8):1239; author reply 1240-1. doi: 10.1016/j.rmed.2009.01.027. Epub 2009 Apr 11. No abstract available.
- Background: PubMed 19853695Winkelmann ER, Chiappa GR, Lima CO, Viecili PR, Stein R, Ribeiro JP. Addition of inspiratory muscle training to aerobic training improves cardiorespiratory responses to exercise in patients with heart failure and inspiratory muscle weakness. Am Heart J. 2009 Nov;158(5):768.e1-7. doi: 10.1016/j.ahj.2009.09.005. Epub 2009 Oct 2.
- Background: PubMed 18436118Chiappa GR, Roseguini BT, Vieira PJ, Alves CN, Tavares A, Winkelmann ER, Ferlin EL, Stein R, Ribeiro JP. Inspiratory muscle training improves blood flow to resting and exercising limbs in patients with chronic heart failure. J Am Coll Cardiol. 2008 Apr 29;51(17):1663-71. doi: 10.1016/j.jacc.2007.12.045.
- Background: PubMed 16608934Koppers RJ, Vos PJ, Boot CR, Folgering HT. Exercise performance improves in patients with COPD due to respiratory muscle endurance training. Chest. 2006 Apr;129(4):886-92. doi: 10.1378/chest.129.4.886.
- Background: PubMed 11069801Scherer TA, Spengler CM, Owassapian D, Imhof E, Boutellier U. Respiratory muscle endurance training in chronic obstructive pulmonary disease: impact on exercise capacity, dyspnea, and quality of life. Am J Respir Crit Care Med. 2000 Nov;162(5):1709-14. doi: 10.1164/ajrccm.162.5.9912026.
- Background: PubMed 19390004McKenzie DK, Butler JE, Gandevia SC. Respiratory muscle function and activation in chronic obstructive pulmonary disease. J Appl Physiol (1985). 2009 Aug;107(2):621-9. doi: 10.1152/japplphysiol.00163.2009. Epub 2009 Apr 23.
- Results publication: PubMed 29927750Paneroni M, Simonelli C, Saleri M, Trainini D, Fokom G, Speltoni I, Piaggi G, Ambrosino N, Vitacca M. Short-Term Effects of Normocapnic Hyperpnea and Exercise Training in Patients With Chronic Obstructive Pulmonary Disease: A Pilot Study. Am J Phys Med Rehabil. 2018 Dec;97(12):866-872. doi: 10.1097/PHM.0000000000000988.
- Individual participant dataSharing planned: Yes. Publication
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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.
Mara Paneroni, PT principal investigator
Fondazione Salvatore Maugeri, Lumezzzane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spirotiger in people with Chronic Obstructive Pulmonary Disease and Congestive Heart Failure, run by Fondazione Salvatore Maugeri at 1 site 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 5 inclusion and 1 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 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Changes in MVV (time frame: baseline and 20 days). 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 NCT01556139, which also lists 10 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 31 Mar 2022.