Effectiveness of Respiratory Muscle Training by Spirotiger in Chronic Patients
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
Chronic Obstructive Pulmonary Disease
Congestive Heart Failure
|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|
- 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)
- 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 ]
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||February 2016|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
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
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:
At the end of 15 minutes of exercise, further increases in ventilation are 10% of each previous step.
No Intervention: Control
Control group with a placebo device
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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556139
|Fondazione Salvatore Maugeri|
|Lumezzane, Brescia, Italy, 25066|
|Principal Investigator:||Mara Paneroni, PT||Fondazione Salvatore Maugeri, Lumezzzane|