Inspiratory Muscle and Peripheral Muscle Training in Chronic Heart Failure

Not Applicable

Completed

• Conditions: Chronic Heart Failure
• Interventions: Other: moderate-intensity group; Other: control; Other: low-intensity group

• Registration Number: NCT02263482
• Lead Sponsor: Naomi Kondo Nakagawa

Brief Summary

Heart failure is a clinical syndrome that is the common end of several cardiac diseases with symptoms such as muscle fatigue, dyspnea and reduction of quality of life. To improve respiratory and general functional capacity of these patients, there are strategies that can be used such as inspiratory muscle training and peripheral muscle training (dynamic resistance training).

Detailed Description

After agreement with the written informed consent, 35 subjects with severe heart failure were included in this study. They were randomized in three groups: controls, low-intensity and moderate-intensity group. All volunteers were assessed at Baseline and 8-weeks intervention. Cardiac events were registered following two years from baseline. The present study aimed to assess the effects of a combined program of inspiratory and peripheral muscle training on respiratory and general functional capacity and quality of life in patients with chronic heart failure.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2014-09-29
• Study First Submitted QC: 2014-10-10
• Study First Posted: 2014-10-13
• Primary Completion: 2015-10
• Status Verified: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-04
• Last Update Posted: 2015-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• chronic heart failure (functional class from NYHA II and III),
• left ventricle ejection fraction bellow or equal 40%.

Exclusion Criteria

• uncontrolled arrhythmia
• pulmonary edema or pulmonary congestion in the last 30 days
• peripheral oxygen saturation bellow 92% in resting condition
• respiratory infection in the previous 30 days to the enrollment into the study
• cognitive, neurological or orthopedic limitations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
moderate-intensity group	moderate-intensity group	Patients will be submitted to a 8-weeks training program, with inspiratory muscle trained at 30% of the maximal inspiratory pressure (30 minutes/session/7 days/week) and peripheral muscle trained with upper and lower exercises (50% of the 1-maximum repetition test).
Control group	control	patients awaiting for evaluation to cardiac rehabilitation or transplantation
low-intensity group	low-intensity group	Patients will be submited to a 8 weeks training program, with inspiratory muscle trained at 15% of the maximal inspiratory pressure (30 minutes/session/7 days/week) and peripheral muscle trained with exercises of upper limbs and lower limbs (0,5 Kg each).

Primary Outcome Measures

Name	Time	Method
Change in respiratory muscle strength (in centimeters of water)	Before and after 8-weeks	Inspiratory and expiratory muscle strength was assessed by using a pressure transducer (MVD-300 Microhard System, GlobalMed, Porto Alegre, Brazil).

Secondary Outcome Measures

Name	Time	Method
walking distance	Before and after 8-weeks	To assess functional capacity using walking distance (6-min walk test accordingly to ATS and ERS guidelines)

Trial Locations

Locations (1)

Instituto Dante Pazzanese de Cardiologia; 🇧🇷 Sao Paulo, Brazil