This trial is active, not recruiting.

Conditions chronic obstructive pulmonary disease, congestive heart failure
Treatment spirotiger
Sponsor Fondazione Salvatore Maugeri
Start date June 2011
End date November 2015
Trial size 40 participants
Trial identifier NCT01556139, Spirotiger


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking single blind (subject)
Primary purpose treatment
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
spirotiger 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.
(No Intervention)
Control group with a placebo device

Primary Outcomes

Changes in MVV
time frame: baseline and 20 days

Secondary Outcomes

Changes in 6-min Walking test
time frame: baseline and 20 days
Changes in Spirometry parameters
time frame: baseline and 20 days

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Evaluation of the Effectiveness of Respiratory Muscle Training by the Technique of Hypocapnia Hyperpnea (Spirotiger) in COPD and CHF Patients
Principal investigator Mara Paneroni, PT
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)
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Fondazione Salvatore Maugeri.