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Completed

NCT Number: NCT01556139

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

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Cardiovascular Diseases Chronic Disease Congestive Heart Failure Disease Attributes Heart Diseases Heart Failure Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Salvatore Maugeri

Lumezzane, Brescia, 25066, Italy

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SpiroTiger

Device

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.

Primary outcomes

  1. Changes in MVV

    Time frame: baseline and 20 days

    In patients with COPD and CHF,endurance is measured by Maximum Voluntary Ventilation Test (MVV)

Secondary outcomes

  1. Changes in 6-min Walking test

    Time frame: baseline and 20 days

  2. Changes in Spirometry parameters

    Time frame: baseline and 20 days

Sponsors and collaborators

Lead sponsor

Fondazione Salvatore Maugeri

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Mar 16, 2012
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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