Effects of Functional Electrical Stimulation and Inspiratory Muscle Training in Heart Failure Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01325597
• Date of registration: 14/03/2011
• Primary sponsor: Instituto de Cardiologia do Rio Grande do Sul
• Public title: Effects of Functional Electrical Stimulation and Inspiratory Muscle Training in Heart Failure Patients
• Scientific title: Effects of Functional Electrical Stimulation and Inspiratory Muscle Training in Heart Failure Patients: Randomized Clinical Trial
• Date of first enrolment: March 2010
• Target sample size: 60
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01325597
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Brazil

Contacts

• Name: Rodrigo DM Plentz, PhD

• Name: Rodrigo DM Plentz, PhD

• Name: Rodrigo DM Plentz, PhD
• Affiliation: Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with stable heart failure and New York Heart Association (NYHA) class II-IV

- Aged 30-70 years

- Left ventricular ejection fraction less than 35% determined by echocardiography and
optimized pharmacological treatment (unchanged 1 month prior to study)

Exclusion Criteria:

- Patients with unstable heart failure

- NYHA class I

- Unstable angina pectoris and ventricular arrhythmia

- Implanted cardiac pacemaker

- Acute pulmonary diseases

- Chronic renal failure or dialysis

- Acute myocardial infarction 3 months before the inclusion in the study

- Acute inflammatory diseases

- Peripheral vascular disease

- Neurologic disease

- Musculoskeletal pathologies

- Malignancies or being an active smoker



Age minimum: 30 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Heart Failure

Intervention(s)

Other: Combined training

Other: Control group

Other: Electrical stimulation

Other: Inspiratory muscle training

Primary Outcome(s)

Functional capacity [Time Frame: 12 weeks]

Secondary Outcome(s)

Autonomic control [Time Frame: 12 weeks]

Endothelial function [Time Frame: 12 weeks]

Oxidative stress [Time Frame: 12 weeks]

Peripheral muscle strength [Time Frame: 12 weeks]

Pulmonary function [Time Frame: 12 weeks]

Quality of life [Time Frame: 12 weeks]

Respiratory muscle strength [Time Frame: 12 weeks]

Secondary ID(s)

UP 4546/10

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Conselho Nacional de Desenvolvimento Científico e Tecnológico