Effectiveness of Respiratory Muscle Training by Spirotiger in Chronic Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Fondazione Salvatore Maugeri.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Mara Paneroni, Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier:
NCT01556139
First received: March 7, 2012
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention
Chronic Obstructive Pulmonary Disease
Congestive Heart Failure
Device: Spirotiger
Other: Control group

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Fondazione Salvatore Maugeri:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: June 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Device: 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.

Other Name: Spirotiger
No Intervention: Control
Control group with a placebo device
Other: Control group
Control group perform 20 sessions of usual training and additional 20 sessions with a placebo device (Threshold)
Other Name: Threshold

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01556139

Contacts
Contact: Mara Paneroni, PT 0039+30+8253122 mara.paneroni@fsm.it
Contact: Michele Vitacca, MD 0039+30+8253182 michele.vitacca@fsm.it

Locations
Italy
Fondazione Salvatore Maugeri Recruiting
Lumezzane, Brescia, Italy, 25066
Contact: Mara Paneroni, PT    0039+30+8253122    mara.paneroni@fsm.it   
Sponsors and Collaborators
Fondazione Salvatore Maugeri
Investigators
Principal Investigator: Mara Paneroni, PT Fondazione Salvatore Maugeri, Lumezzzane
  More Information

Publications:

Responsible Party: Mara Paneroni, Study Investigator, Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier: NCT01556139     History of Changes
Other Study ID Numbers: Spirotiger
Study First Received: March 7, 2012
Last Updated: March 15, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Fondazione Salvatore Maugeri:
Endurance
exercise training
6-min walking test

Additional relevant MeSH terms:
Heart Failure
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 01, 2014