Inspiratory Muscle Training in Patients With Chronic Heart Failure

NCT01606553 | Completed

• 1 other identifier: INCA
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Heart Failure

Keywords

chronic heart failure; respiratory muscle weakness; inspiratory muscle training

Outcome Measures

Primary Outcomes (1)

• Change in respiratory muscle function strength

  Transducer measuring maximal inspiratory and expiratory pressures

  Baseline to 4 weeks

Secondary Outcomes (3)

• Change in health-related quality of life

  Baseline to 4 weeks

• Adverse effects from training

  Baseline to week 4

• Health care utilization

  Baseline to one year

Study Arms (2)

High-intensity IMT

EXPERIMENTAL

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

Device: High-intensity IMT

Sham High-intensity IMT

ACTIVE COMPARATOR

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

Device: Sham High-intensity IMT

Interventions

High-intensity IMT DEVICE

High intensity short duration respiratory muscle training with a valve prototype

Also known as: Orygen-Dual valve prototype

High-intensity IMT

Sham High-intensity IMT DEVICE

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

Also known as: Sham Orygen-Dual valve prototype

Sham High-intensity IMT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Related Publications (1)

• 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.

  PMID: 23512093 DERIVED

Study Officials

• Ferran Escalada, MD, PhD

  Parc de Salut Mar

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 21, 2012
• First Posted: May 25, 2012
• Study Start: October 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 17, 2016

Record last verified: 2016-02

Locations

ES (1)