Effectiveness of Respiratory Muscle Training by Spirotiger in Chronic Patients

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; Congestive Heart Failure
• Interventions: Device: Spirotiger

• Registration Number: NCT01556139
• Lead Sponsor: Fondazione Salvatore Maugeri

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)

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2012-03-07
• Study First Submitted QC: 2012-03-15
• Study First Posted: 2012-03-16
• Primary Completion: 2015-11
• Study Completion: 2016-02
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-16
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Spirotiger	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

Primary Outcome Measures

Name	Time	Method
Changes in MVV	baseline and 20 days	In patients with COPD and CHF,endurance is measured by Maximum Voluntary Ventilation Test (MVV)

Secondary Outcome Measures

Name	Time	Method
Changes in 6-min Walking test	baseline and 20 days
Changes in Spirometry parameters	baseline and 20 days

Trial Locations

Locations (1)

Fondazione Salvatore Maugeri; 🇮🇹 Lumezzane, Brescia, Italy