Effectiveness of Respiratory Muscle Training by Spirotiger in Chronic Patients

Fondazione Salvatore Maugeri

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease; Congestive Heart Failure

Treatments: Device: Spirotiger

Study type: Interventional

Funder types: Other

Identifiers

NCT01556139

Spirotiger

Details and patient eligibility

About

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

Full 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)

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Spirotiger

Experimental group

Description:

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

Treatment:

Device: Spirotiger

Control

No Intervention group

Description:

Control group with a placebo device