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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Parc de Salut Mar.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Parc de Salut Mar
ClinicalTrials.gov Identifier:
NCT01606553
First received: May 21, 2012
Last updated: May 23, 2012
Last verified: May 2012

May 21, 2012
May 23, 2012
April 2012
December 2012   (final data collection date for primary outcome measure)
Change in respiratory muscle function strength [ Time Frame: Baseline to 4 weeks ] [ Designated as safety issue: No ]
Transducer measuring maximal inspiratory and expiratory pressures
Same as current
Complete list of historical versions of study NCT01606553 on ClinicalTrials.gov Archive Site
  • Change in health-related quality of life [ Time Frame: Baseline to 4 weeks ] [ Designated as safety issue: No ]
    Minnesotta Living wih Heart Failure Questionnaire and Short Form 36
  • Adverse effects from training [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: Yes ]
    Adversese events collection by investigator
  • Health care utilization [ Time Frame: Baseline to one year ] [ Designated as safety issue: No ]
    Hospital admissions and emergency room visits
Same as current
Not Provided
Not Provided
 
Inspiratory Muscle Training in Patients With Chronic Heart Failure
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Heart Failure
  • Device: High-intensity IMT
    High intensity short duration respiratory muscle training with a valve prototype
    Other Name: Orygen-Dual valve 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
  • Experimental: High-intensity IMT
    High intensity short duration respiratory muscle training (IMT) using a dual-vave prototype
    Intervention: Device: High-intensity IMT
  • Active Comparator: Sham High-intensity IMT
    High intensity short duration respiratory muscle training (IMT) using a sham dual-vave prototype
    Intervention: Device: Sham High-intensity IMT
Marco E, Ramírez-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
22
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Ester Marco, MD, PhD +34 933674214 emarco@hospitaldelmar.cat
Spain
 
NCT01606553
INCA
No
Parc de Salut Mar
Parc de Salut Mar
Not Provided
Study Director: Ferran Escalada, MD, PhD Parc de Salut Mar
Parc de Salut Mar
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP