Inspiratory Muscle Training in Patients With Chronic Heart Failure

NCT ID: NCT01606553

Last Updated: 2016-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-06-30

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.

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.

Conditions

Chronic Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

High-intensity IMT

High intensity short duration respiratory muscle training (IMT) using a dual-vave prototype

Group Type: EXPERIMENTAL

High-intensity IMT

Intervention Type: DEVICE

High intensity short duration respiratory muscle training with a valve prototype

Sham High-intensity IMT

High intensity short duration respiratory muscle training (IMT) using a sham dual-vave prototype

Group Type: ACTIVE_COMPARATOR

Sham High-intensity IMT

Intervention Type: DEVICE

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

Interventions

High-intensity IMT

High intensity short duration respiratory muscle training with a valve prototype

Intervention Type: DEVICE

Sham High-intensity IMT

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

Intervention Type: DEVICE

Other Intervention Names

Orygen-Dual valve prototype; Sham Orygen-Dual valve prototype

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parc de Salut Mar

OTHER

Sponsor Role: lead

Responsible Party

Esther Marco Navarro

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ferran Escalada, MD, PhD

Role: STUDY_DIRECTOR

Parc de Salut Mar

Locations

Hospital del Mar

Barcelona, Barcelona, Spain

Countries

Spain

References

Marco E, Ramirez-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.

Reference Type: DERIVED

PMID: 23512093 (View on PubMed)

Other Identifiers

INCA

Identifier Type: -

Identifier Source: org_study_id