Exercise Training Associated With Inspiratory Muscle Training in Heart Failure

Heart Failure Clinical Trial

Official title:

Effects of Aerobic Exercise Training Associated With Inspiratory Muscle Training in Patients With Heart Failure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01747395
• Other study ID #: ICRESP814/10
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2012
• Est. completion date: July 2021

Study information

• Verified date: April 2021
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: July 2021
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Exercise training
The heart failure patients are subjected to differents protocols of physical training

Locations

Country	Name	City	State
Brazil	Instituto do Coração - HC/FMUSP	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Autonomic control	Exercise training associated with inspiratory muscle training will reduce sympathetic nerve activity.	4 months
Secondary	Functional Capacity	Exercise training associated with inspiratory muscle training will improve peak oxygen consumption	4 months
Secondary	Quality of life	Exercise training associated with inspiratory muscle training will improve quality of life	4 months
Secondary	Blood inflammatory markers	Exercise training associated with inspiratory muscle training will reduces blood inflammatory markers	4 months
Secondary	Muscular evaluation	Exercise training associated with inspiratory muscle training will increase skeletal muscle strength	4 months
Secondary	Respiratoy muscle function	Exercise training associated with inspiratory muscle training will increase inspitarory muscle strength and endurance.	4 months