Effectiveness of Respiratory Muscle Training by Spirotiger in Chronic Patients
Primary Purpose
Chronic Obstructive Pulmonary Disease, Congestive Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Spirotiger
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Endurance, exercise training, 6-min walking test
Eligibility 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
Sites / Locations
- Fondazione Salvatore Maugeri
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Spirotiger
Control
Arm Description
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
Control group with a placebo device
Outcomes
Primary Outcome Measures
Changes in MVV
In patients with COPD and CHF,endurance is measured by Maximum Voluntary Ventilation Test (MVV)
Secondary Outcome Measures
Changes in 6-min Walking test
Changes in Spirometry parameters
Full Information
NCT ID
NCT01556139
First Posted
March 7, 2012
Last Updated
March 16, 2022
Sponsor
Fondazione Salvatore Maugeri
1. Study Identification
Unique Protocol Identification Number
NCT01556139
Brief Title
Effectiveness of Respiratory Muscle Training by Spirotiger in Chronic Patients
Official Title
Evaluation of the Effectiveness of Respiratory Muscle Training by the Technique of Hypocapnia Hyperpnea (Spirotiger) in COPD and CHF Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Salvatore Maugeri
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Congestive Heart Failure
Keywords
Endurance, exercise training, 6-min walking test
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spirotiger
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group with a placebo device
Intervention Type
Device
Intervention Name(s)
Spirotiger
Intervention Description
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 Outcome Measure Information:
Title
Changes in MVV
Description
In patients with COPD and CHF,endurance is measured by Maximum Voluntary Ventilation Test (MVV)
Time Frame
baseline and 20 days
Secondary Outcome Measure Information:
Title
Changes in 6-min Walking test
Time Frame
baseline and 20 days
Title
Changes in Spirometry parameters
Time Frame
baseline and 20 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mara Paneroni, PT
Organizational Affiliation
Fondazione Salvatore Maugeri, Lumezzzane
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione Salvatore Maugeri
City
Lumezzane
State/Province
Brescia
ZIP/Postal Code
25066
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Publication
Citations:
PubMed Identifier
19486593
Citation
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.
Results Reference
background
PubMed Identifier
19474739
Citation
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.
Results Reference
background
PubMed Identifier
19480865
Citation
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.
Results Reference
background
PubMed Identifier
19362808
Citation
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.
Results Reference
background
PubMed Identifier
19853695
Citation
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.
Results Reference
background
PubMed Identifier
18436118
Citation
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.
Results Reference
background
PubMed Identifier
16608934
Citation
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.
Results Reference
background
PubMed Identifier
11069801
Citation
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.
Results Reference
background
PubMed Identifier
19390004
Citation
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.
Results Reference
background
PubMed Identifier
29927750
Citation
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.
Results Reference
result
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Effectiveness of Respiratory Muscle Training by Spirotiger in Chronic Patients
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