Clinical trial NCT01556139: Effectiveness of Respiratory Muscle Training by Spirotiger in Chronic Patients
Official title: Evaluation of the Effectiveness of Respiratory Muscle Training by the Technique of Hypocapnia Hyperpnea (Spirotiger) in COPD and CHF Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Congestive Heart Failure
Keywords: Endurance
exercise training
6-min walking test
Lead sponsor: Fondazione Salvatore Maugeri
Sponsor class: OTHER
First posted: 2012-03-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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:

1. 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
2. Control Group: these patients perform 20 sessions of usual training (cyclette and calisthenic exercises) and additional 20 sessions with a placebo device (Threshold)

Eligibility criteria: Inclusion Criteria:

* 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%.

Exclusion Criteria:

* Haemodynamic instability

Primary outcomes:
measure: Changes in MVV
timeFrame: baseline and 20 days
Secondary outcomes:
measure: Changes in 6-min Walking test
timeFrame: baseline and 20 days
measure: Changes in Spirometry parameters
timeFrame: baseline and 20 days
Other outcomes:
Locations:
city: Lumezzane
country: Italy
facility: Fondazione Salvatore Maugeri
state: Brescia
Study officials:
affiliation: Fondazione Salvatore Maugeri, Lumezzzane
name: Mara Paneroni, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Frankenstein 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.
citation: Battaglia 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.
citation: Powell 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.
citation: Winkelmann 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.
citation: Chiappa 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.
citation: Koppers 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.
citation: Scherer 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.
citation: McKenzie 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.
citation: Paneroni 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.