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Completed

NCT Number: NCT01606553

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital del Mar

Barcelona, 08003, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High-intensity IMT

Device

High intensity short duration respiratory muscle training with a valve prototype

Other names: Orygen-Dual valve prototype

Sham High-intensity IMT

Device

High intensity short duration respiratory muscle training using a sham valve prototype

Other names: Sham Orygen-Dual valve prototype

Primary outcomes

  1. Change in respiratory muscle function strength

    Time frame: Baseline to 4 weeks

    Transducer measuring maximal inspiratory and expiratory pressures

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Registry information

Official study title

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

Acronym: INCA

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 25, 2012
Registry last updated
Feb 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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