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

This study is currently recruiting participants.
Verified May 2012 by Parc de Salut Mar
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
  Purpose

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 Intervention
Chronic Heart Failure
Device: High-intensity IMT
Device: Sham High-intensity IMT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The INCA Study: Inspiratory Muscle Training in Patients With Chronic Heart Failure

Resource links provided by NLM:


Further study details as provided by Parc de Salut Mar:

Primary Outcome Measures:
  • Change in respiratory muscle function strength [ Time Frame: Baseline to 4 weeks ] [ Designated as safety issue: No ]
    Transducer measuring maximal inspiratory and expiratory pressures


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 22
Study Start Date: April 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01606553

Contacts
Contact: Ester Marco, MD, PhD +34 933674214 emarco@hospitaldelmar.cat

Locations
Spain
Hospital del Mar Recruiting
Barcelona, Spain, 08003
Sub-Investigator: Anna Coloma, MD         
Sub-Investigator: Alba L Ramirez-Sarmiento, Physioter         
Sub-Investigator: Monique Sator, Physioter         
Sub-Investigator: Josep Comin, MD, PhD         
Sub-Investigator: Ferran Escalada, MD, PhD         
Sub-Investigator: Joaquim Gea, MD, PhD         
Principal Investigator: Ester Marco, MD, PhD         
Sponsors and Collaborators
Parc de Salut Mar
Investigators
Study Director: Ferran Escalada, MD, PhD Parc de Salut Mar
  More Information

No publications provided by Parc de Salut Mar

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT01606553     History of Changes
Other Study ID Numbers: INCA
Study First Received: May 21, 2012
Last Updated: May 23, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Parc de Salut Mar:
chronic heart failure
respiratory muscle weakness
inspiratory muscle training

Additional relevant MeSH terms:
Respiratory Aspiration
Heart Failure
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 14, 2014