Exercise Training Associated With Inspiratory Muscle Training in Heart Failure

Not Applicable

• Conditions: Heart Failure
• Interventions: Other: Exercise training

• Registration Number: NCT01747395
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

The investigators hypothesize that aerobic exercise training associated with respiratory muscle training will cause additional benefits compared to isolated exercise training or respiratory training in chronic heart failure patients.

Detailed Description

The investigators hypothesize that aerobic exercise training associated with respiratory muscle training will cause additional benefits in the autonomic control and respiratory function compared to isolated exercise training or respiratory training in chronic heart failure patients.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-12-06
• Study First Submitted QC: 2012-12-07
• Study First Posted: 2012-12-11
• Primary Completion: 2020-04
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-30
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients with systolic heart failure and New York Heart Association (NYHA) class II-III
• Left ventricular ejection fraction less than 40%
• Peak Oxygen Consumption less than 20 ml/Kg/min

Exclusion Criteria

• Chronic Obstructive Pulmonary Disease
• Neuromuscular, Orthopedic, Neurologic and Neoplastic Diseases
• Recent myocardial infarction or cardiac surgery (less than 6 months)
• Unstable angina pectoris
• Atrial Fibrillation
• Pacemakers users
• Actual Smoker
• Pregnant
• Changing medication or hospital admission

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aerobic Exercise Training	Exercise training	Group undergoing isolate aerobic exercise training 3 times/week, during 40 minutes, for 04 mouths
Inspiratory Muscle Training	Exercise training	Group undergoing isolate inspiratory muscle training 7 times/week, during 30 minutes, for 04 mouths
Aerobic+Inspiratory Muscle Training	Exercise training	Group undergoing aerobic exercise training (3 times/week during 40 minutes) associate inspiratory muscle training (7 times/week during 30 minutes) for 04 mounths

Primary Outcome Measures

Name	Time	Method
Autonomic control	4 months	Exercise training associated with inspiratory muscle training will reduce sympathetic nerve activity.

Secondary Outcome Measures

Name	Time	Method
Respiratoy muscle function	4 months	Exercise training associated with inspiratory muscle training will increase inspitarory muscle strength and endurance.
Blood inflammatory markers	4 months	Exercise training associated with inspiratory muscle training will reduces blood inflammatory markers
Quality of life	4 months	Exercise training associated with inspiratory muscle training will improve quality of life
Functional Capacity	4 months	Exercise training associated with inspiratory muscle training will improve peak oxygen consumption
Muscular evaluation	4 months	Exercise training associated with inspiratory muscle training will increase skeletal muscle strength

Trial Locations

Locations (1)

Instituto do Coração - HC/FMUSP; 🇧🇷 São Paulo, SP, Brazil