Inspiratory Muscle Training With Normocapnic Hyperpnea in Chronic Obstructive Pulmonary Disease (COPD)
Efficacy of Inspiratory Muscle Training by Means of Spirotiger® in COPD Patients.
1 other identifier
interventional
20
1 country
1
Brief Summary
Many studies suggest that inspiratory muscles training by means of normocapnic hyperpnea improves exercise tolerance in healthy subjects. No information is available about the use of this training in COPD patients even if other methods (such as threshold loading and resistive loading) have been shown to be effective in terms of Inspiratory Muscle Function, Health-Related Quality of Life and Exercise Tolerance. This study is designed to evaluate the effects of normocapnic hyperventilation by means of Spirotiger®, an instrument training the respiratory muscles, avoiding hypocapnia (using the methodology of isocapnic hyperpnoea)in COPD patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 7, 2010
CompletedFirst Posted
Study publicly available on registry
October 11, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedOctober 11, 2010
October 1, 2010
2.1 years
October 7, 2010
October 8, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Exercise Capacity
1 month
Study Arms (1)
Respiratory muscle training
EXPERIMENTALPatients assigned to this arm train the respiratory muscles by means of normocapnic hyperpnea.
Interventions
training session :10 minutes twice a day X 4 weeks
Eligibility Criteria
You may qualify if:
- COPD patients. All patients are at stable state, free from an exacerbation from at least 3 months.
You may not qualify if:
- COPD patients with a recent history of cardiovascular disease, neurologic disease and other diseases that would interfere with the training.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pulmonary Respiratory Unit- University Hospital
Ferrara, Ferrara, 44100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Annalisa Cogo, MD
Università di Ferrara
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 7, 2010
First Posted
October 11, 2010
Study Start
May 1, 2009
Primary Completion
June 1, 2011
Study Completion
July 1, 2011
Last Updated
October 11, 2010
Record last verified: 2010-10