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

February 15, 2016 updated by: Esther Marco Navarro, Parc de Salut Mar

The INCA Study: Inspiratory Muscle Training in Patients With Chronic Heart Failure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Sham Orygen-Dual valve prototype

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in respiratory muscle function strength
Time Frame: Baseline to 4 weeks
Transducer measuring maximal inspiratory and expiratory pressures
Baseline to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in health-related quality of life
Time Frame: Baseline to 4 weeks
Minnesotta Living wih Heart Failure Questionnaire and Short Form 36
Baseline to 4 weeks
Adverse effects from training
Time Frame: Baseline to week 4
Adverse events collection by investigator
Baseline to week 4
Health care utilization
Time Frame: Baseline to one year
Hospital admissions and emergency room visits
Baseline to one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parc de Salut Mar

Investigators

  • Study Director: Ferran Escalada, Md, PhD, Parc de Salut Mar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

May 21, 2012

First Submitted That Met QC Criteria

May 23, 2012

First Posted (Estimate)

May 25, 2012

Study Record Updates

Last Update Posted (Estimate)

February 17, 2016

Last Update Submitted That Met QC Criteria

February 15, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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