Effectiveness of Respiratory Muscle Training by Spirotiger in Chronic Patients

NCT01556139 | Completed

• 1 other identifier: Spirotiger
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Obstructive Pulmonary Disease; Congestive Heart Failure

Keywords

Endurance; exercise training; 6-min walking test

Outcome Measures

Primary Outcomes (1)

• Changes in MVV

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

  baseline and 20 days

Secondary Outcomes (2)

• Changes in 6-min Walking test

  baseline and 20 days

• Changes in Spirometry parameters

  baseline and 20 days

Study Arms (2)

Spirotiger

EXPERIMENTAL

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

Control

NO INTERVENTION

Control group with a placebo device

Interventions

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.

Spirotiger

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• Haemodynamic instability

Sponsors & Collaborators

• Fondazione Salvatore Maugeri: lead

Study Sites (1)

Fondazione Salvatore Maugeri

Lumezzane, Brescia, 25066, Italy

Location

Related Publications (10)

• Ribeiro JP, Chiappa GR, Neder JA, Frankenstein L. Respiratory muscle function and exercise intolerance in heart failure. Curr Heart Fail Rep. 2009 Jun;6(2):95-101. doi: 10.1007/s11897-009-0015-7.

  PMID: 19486593 BACKGROUND

• Frankenstein L, Nelles M, Meyer FJ, Sigg C, Schellberg D, Remppis BA, Katus HA, Zugck C. Validity, prognostic value and optimal cutoff of respiratory muscle strength in patients with chronic heart failure changes with beta-blocker treatment. Eur J Cardiovasc Prev Rehabil. 2009 Aug;16(4):424-9. doi: 10.1097/HJR.0b013e3283030a7e.

  PMID: 19474739 BACKGROUND

• Battaglia E, Fulgenzi A, Ferrero ME. Rationale of the combined use of inspiratory and expiratory devices in improving maximal inspiratory pressure and maximal expiratory pressure of patients with chronic obstructive pulmonary disease. Arch Phys Med Rehabil. 2009 Jun;90(6):913-8. doi: 10.1016/j.apmr.2008.12.019.

  PMID: 19480865 BACKGROUND

• Powell T, Williams EM. Inspiratory muscle training in adults with COPD. Respir Med. 2009 Aug;103(8):1239; author reply 1240-1. doi: 10.1016/j.rmed.2009.01.027. Epub 2009 Apr 11. No abstract available.

  PMID: 19362808 BACKGROUND

• Winkelmann ER, Chiappa GR, Lima CO, Viecili PR, Stein R, Ribeiro JP. Addition of inspiratory muscle training to aerobic training improves cardiorespiratory responses to exercise in patients with heart failure and inspiratory muscle weakness. Am Heart J. 2009 Nov;158(5):768.e1-7. doi: 10.1016/j.ahj.2009.09.005. Epub 2009 Oct 2.

  PMID: 19853695 BACKGROUND

• Chiappa GR, Roseguini BT, Vieira PJ, Alves CN, Tavares A, Winkelmann ER, Ferlin EL, Stein R, Ribeiro JP. Inspiratory muscle training improves blood flow to resting and exercising limbs in patients with chronic heart failure. J Am Coll Cardiol. 2008 Apr 29;51(17):1663-71. doi: 10.1016/j.jacc.2007.12.045.

  PMID: 18436118 BACKGROUND

• Koppers RJ, Vos PJ, Boot CR, Folgering HT. Exercise performance improves in patients with COPD due to respiratory muscle endurance training. Chest. 2006 Apr;129(4):886-92. doi: 10.1378/chest.129.4.886.

  PMID: 16608934 BACKGROUND

• Scherer TA, Spengler CM, Owassapian D, Imhof E, Boutellier U. Respiratory muscle endurance training in chronic obstructive pulmonary disease: impact on exercise capacity, dyspnea, and quality of life. Am J Respir Crit Care Med. 2000 Nov;162(5):1709-14. doi: 10.1164/ajrccm.162.5.9912026.

  PMID: 11069801 BACKGROUND

• McKenzie DK, Butler JE, Gandevia SC. Respiratory muscle function and activation in chronic obstructive pulmonary disease. J Appl Physiol (1985). 2009 Aug;107(2):621-9. doi: 10.1152/japplphysiol.00163.2009. Epub 2009 Apr 23.

  PMID: 19390004 BACKGROUND

• Paneroni M, Simonelli C, Saleri M, Trainini D, Fokom G, Speltoni I, Piaggi G, Ambrosino N, Vitacca M. Short-Term Effects of Normocapnic Hyperpnea and Exercise Training in Patients With Chronic Obstructive Pulmonary Disease: A Pilot Study. Am J Phys Med Rehabil. 2018 Dec;97(12):866-872. doi: 10.1097/PHM.0000000000000988.

  PMID: 29927750 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Heart Failure

Condition Hierarchy (Ancestors)

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

Study Officials

• Mara Paneroni, PT

  Fondazione Salvatore Maugeri, Lumezzzane

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Investigator

Study Record Dates

• First Submitted: March 7, 2012
• First Posted: March 16, 2012
• Study Start: June 1, 2011
• Primary Completion: November 1, 2015
• Study Completion: February 1, 2016
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)