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Inspiratory Muscle Training in Patients With Chronic Heart Failure (INCA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01606553
Recruitment Status : Completed
First Posted : May 25, 2012
Last Update Posted : February 17, 2016
Information provided by (Responsible Party):
Esther Marco Navarro, Parc de Salut Mar

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.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Device: High-intensity IMT Device: Sham High-intensity IMT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The INCA Study: Inspiratory Muscle Training in Patients With Chronic Heart Failure
Study Start Date : October 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: High-intensity IMT
High intensity short duration respiratory muscle training (IMT) using a dual-vave prototype
Device: High-intensity IMT
High intensity short duration respiratory muscle training with a valve prototype
Other Name: Orygen-Dual valve prototype

Active Comparator: Sham High-intensity IMT
High intensity short duration respiratory muscle training (IMT) using a sham dual-vave prototype
Device: Sham High-intensity IMT
High intensity short duration respiratory muscle training using a sham valve prototype
Other Name: Sham Orygen-Dual valve prototype

Primary Outcome Measures :
  1. Change in respiratory muscle function strength [ Time Frame: Baseline to 4 weeks ]
    Transducer measuring maximal inspiratory and expiratory pressures

Secondary Outcome Measures :
  1. Change in health-related quality of life [ Time Frame: Baseline to 4 weeks ]
    Minnesotta Living wih Heart Failure Questionnaire and Short Form 36

  2. Adverse effects from training [ Time Frame: Baseline to week 4 ]
    Adverse events collection by investigator

  3. Health care utilization [ Time Frame: Baseline to one year ]
    Hospital admissions and emergency room visits

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. age over 18 years;
  2. chronic heart failure (CHF) of any etiology;
  3. clinically stable condition, with no worsening of heart failure or change in cardiac medication in the previous 3 months and during the study; and
  4. ability to understand and accept the trial procedures and to sign an informed consent form in accordance with national legislation.

Exclusion Criteria:

  1. previous history of any chronic respiratory disease;
  2. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01606553

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Hospital del Mar
Barcelona, Spain, 08003
Sponsors and Collaborators
Parc de Salut Mar
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Study Director: Ferran Escalada, MD, PhD Parc de Salut Mar
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Esther Marco Navarro, MD, Parc de Salut Mar Identifier: NCT01606553    
Other Study ID Numbers: INCA
First Posted: May 25, 2012    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Keywords provided by Esther Marco Navarro, Parc de Salut Mar:
chronic heart failure
respiratory muscle weakness
inspiratory muscle training
Additional relevant MeSH terms:
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Respiratory Aspiration
Heart Failure
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes