Inspiratory Muscle Training in Patients With Chronic Heart Failure (INCA)
Primary Purpose
Chronic Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
High-intensity IMT
Sham High-intensity IMT
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Heart Failure focused on measuring chronic heart failure, respiratory muscle weakness, inspiratory muscle training
Eligibility Criteria
Inclusion Criteria:
- age over 18 years;
- chronic heart failure (CHF) of any etiology;
- clinically stable condition, with no worsening of heart failure or change in cardiac medication in the previous 3 months and during the study; and
- ability to understand and accept the trial procedures and to sign an informed consent form in accordance with national legislation.
Exclusion Criteria:
- previous history of any chronic respiratory disease;
not to have performed any kind of general or respiratory training in the previous 3 months.
- Prior to randomization, all patients' clinical assessment and echocardiographic measurements were done by a cardiologist and all patients underwent pulmonary function tests.
Sites / Locations
- Hospital del Mar
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High-intensity IMT
Sham High-intensity IMT
Arm Description
High intensity short duration respiratory muscle training (IMT) using a dual-vave prototype
High intensity short duration respiratory muscle training (IMT) using a sham dual-vave prototype
Outcomes
Primary Outcome Measures
Change in respiratory muscle function strength
Transducer measuring maximal inspiratory and expiratory pressures
Secondary Outcome Measures
Change in health-related quality of life
Minnesotta Living wih Heart Failure Questionnaire and Short Form 36
Adverse effects from training
Adverse events collection by investigator
Health care utilization
Hospital admissions and emergency room visits
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01606553
Brief Title
Inspiratory Muscle Training in Patients With Chronic Heart Failure
Acronym
INCA
Official Title
The INCA Study: Inspiratory Muscle Training in Patients With Chronic Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parc de Salut Mar
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether a high intensity short duration inspiratory muscle training is feasible, secure and effective to improve respiratory muscle function (strength and resistance), health-related quality of life, and to assess potential correlations with health resources utilization.
Detailed Description
Patients with chronic heart failure (CHF) often refer exercise intolerance, marked fatigue and dyspnea at low exercise intensities. This characteristic feature might be generated by respiratory and skeletal muscle dysfunction, and it´s has been described as a comorbid status, reflecting the systemic impact of heart failure. Despite the availability of effective pharmacologic treatments, patients with CHF continue to experience progressively worsening symptoms, frequent hospital admission and premature death. Reduced physical functioning, role limitation, and lack of energy may interfere with daily activities as the condition worsens and thereby severely reduce the quality of life in CHF patients. The ACCF/AHA Guidelines for the diagnosis and management of heart failure recommend exercise training as an adjunctive approach to improve clinical status in stable adult patients with current or prior symptoms of heart failure and reduced left ventricular ejection fraction. A wide variety of studies have focussed on respiratory muscles abnormalities in CHF patients. Reduced strength and endurance of respiratory muscles are currently recognized as additional factors implicated in the limited exercise response and quality of life, as well as in a poor prognosis. Additionally, inspiratory muscle training (IMT) has shown to result in improvements on inspiratory strength, functional capacity, ventilatory response to exercise, recovery oxygen uptake kinetics, and quality of life of CHF patients with respiratory muscle weakness. The optimal training scheme remains still to be defined. Most of clinical trials have demonstrated the effectiveness of a low-intensity IMT (maximum 38 cmH2O), but there is little information of the training effects when using higher training loads. Our research group has demonstrated that a short-time high-intensity respiratory training in patients with chronic obstructive pulmonary disease afford to reach good functional results in a shorter time, which affords to make more efficient in terms of time the rehabilitation program and to reach to more patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
chronic heart failure, respiratory muscle weakness, inspiratory muscle training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High-intensity IMT
Arm Type
Experimental
Arm Description
High intensity short duration respiratory muscle training (IMT) using a dual-vave prototype
Arm Title
Sham High-intensity IMT
Arm Type
Active Comparator
Arm Description
High intensity short duration respiratory muscle training (IMT) using a sham dual-vave prototype
Intervention Type
Device
Intervention Name(s)
High-intensity IMT
Other Intervention Name(s)
Orygen-Dual valve prototype
Intervention Description
High intensity short duration respiratory muscle training with a valve prototype
Intervention Type
Device
Intervention Name(s)
Sham High-intensity IMT
Other Intervention Name(s)
Sham Orygen-Dual valve prototype
Intervention Description
High intensity short duration respiratory muscle training using a sham valve prototype
Primary Outcome Measure Information:
Title
Change in respiratory muscle function strength
Description
Transducer measuring maximal inspiratory and expiratory pressures
Time Frame
Baseline to 4 weeks
Secondary Outcome Measure Information:
Title
Change in health-related quality of life
Description
Minnesotta Living wih Heart Failure Questionnaire and Short Form 36
Time Frame
Baseline to 4 weeks
Title
Adverse effects from training
Description
Adverse events collection by investigator
Time Frame
Baseline to week 4
Title
Health care utilization
Description
Hospital admissions and emergency room visits
Time Frame
Baseline to one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age over 18 years;
chronic heart failure (CHF) of any etiology;
clinically stable condition, with no worsening of heart failure or change in cardiac medication in the previous 3 months and during the study; and
ability to understand and accept the trial procedures and to sign an informed consent form in accordance with national legislation.
Exclusion Criteria:
previous history of any chronic respiratory disease;
not to have performed any kind of general or respiratory training in the previous 3 months.
Prior to randomization, all patients' clinical assessment and echocardiographic measurements were done by a cardiologist and all patients underwent pulmonary function tests.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ferran Escalada, MD, PhD
Organizational Affiliation
Parc de Salut Mar
Official's Role
Study Director
Facility Information:
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
23512093
Citation
Marco E, Ramirez-Sarmiento AL, Coloma A, Sartor M, Comin-Colet J, Vila J, Enjuanes C, Bruguera J, Escalada F, Gea J, Orozco-Levi M. High-intensity vs. sham inspiratory muscle training in patients with chronic heart failure: a prospective randomized trial. Eur J Heart Fail. 2013 Aug;15(8):892-901. doi: 10.1093/eurjhf/hft035. Epub 2013 Mar 19.
Results Reference
derived
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Inspiratory Muscle Training in Patients With Chronic Heart Failure
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