CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Spirotigerdevice
Likely dose
Not stated in record
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Search/NCT01556139
NCT01556139N/ACompleted

Evaluation of the Effectiveness of Respiratory Muscle Training by the Technique of Hypocapnia Hyperpnea (Spirotiger) in COPD and CHF Patients

Fondazione Salvatore Maugeri·interventional·Posted Mar 16, 2012·Updated Mar 31, 2022

In Brief

A clinical study evaluating Spirotiger for Chronic Obstructive Pulmonary Disease and Congestive Heart Failure. Completed, enrolled 40 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 16, 2012
Enrollment StartJun 1, 2011
Primary CompletionNov 1, 2015
Study CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 14.3 years ago

Interventions

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.