Effectiveness of Respiratory Muscle Training by Spirotiger in Chronic Patients - Full Text View

Purpose

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

Condition	Intervention
Chronic Obstructive Pulmonary Disease Congestive Heart Failure	Device: Spirotiger Other: Control group

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Evaluation of the Effectiveness of Respiratory Muscle Training by the Technique of Hypocapnia Hyperpnea (Spirotiger) in COPD and CHF Patients

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Exercise and Physical Fitness Heart Failure

U.S. FDA Resources

Further study details as provided by Fondazione Salvatore Maugeri:

Primary Outcome Measures:

Changes in MVV [ Time Frame: baseline and 20 days ] [ Designated as safety issue: No ]
In patients with COPD and CHF,endurance is measured by Maximum Voluntary Ventilation Test (MVV)

Secondary Outcome Measures:

Changes in 6-min Walking test [ Time Frame: baseline and 20 days ] [ Designated as safety issue: No ]
Changes in Spirometry parameters [ Time Frame: baseline and 20 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	June 2011
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Spirotiger 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	Device: Spirotiger 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. Other Name: Spirotiger
No Intervention: Control Control group with a placebo device	Other: Control group Control group perform 20 sessions of usual training and additional 20 sessions with a placebo device (Threshold) Other Name: Threshold

Arms

Assigned Interventions

Experimental: Spirotiger

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

Device: Spirotiger

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.

Other Name: Spirotiger

No Intervention: Control

Control group with a placebo device

Other: Control group

Control group perform 20 sessions of usual training and additional 20 sessions with a placebo device (Threshold)

Other Name: Threshold

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)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01556139

Contacts

Contact: Mara Paneroni, PT	0039+30+8253122	mara.paneroni@fsm.it
Contact: Michele Vitacca, MD	0039+30+8253182	michele.vitacca@fsm.it

Locations

Italy
Fondazione Salvatore Maugeri	Recruiting
Lumezzane, Brescia, Italy, 25066
Contact: Mara Paneroni, PT 0039+30+8253122 mara.paneroni@fsm.it

Sponsors and Collaborators

Fondazione Salvatore Maugeri

Investigators

Principal Investigator:

Mara Paneroni, PT

Fondazione Salvatore Maugeri, Lumezzzane

More Information

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. Review.

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.

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.

Powell T, Williams EM. Inspiratory muscle training in adults with COPD. Respir Med. 2009 Aug;103(8):1239; author reply 1240-1. Epub 2009 Apr 11.

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. Epub 2009 Oct 2.

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.

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.

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.

McKenzie DK, Butler JE, Gandevia SC. Respiratory muscle function and activation in chronic obstructive pulmonary disease. J Appl Physiol. 2009 Aug;107(2):621-9. Epub 2009 Apr 23. Review.

Responsible Party:	Mara Paneroni, Study Investigator, Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier:	NCT01556139 History of Changes
Other Study ID Numbers:	Spirotiger
Study First Received:	March 7, 2012
Last Updated:	March 15, 2012
Health Authority:	Italy: Ethics Committee

Keywords provided by Fondazione Salvatore Maugeri:

Endurance
exercise training
6-min walking test

Additional relevant MeSH terms:

Heart Failure
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

Lung Diseases, Obstructive
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013