Inspiratory Muscle and Peripheral Muscle Training in Chronic Heart Failure

NCT ID: NCT02263482

Last Updated: 2015-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2015-12-31

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.

Conditions

Chronic Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

patients awaiting for evaluation to cardiac rehabilitation or transplantation

Group Type: OTHER

control

Intervention Type: OTHER

No intervention during the 8-weeks period of the study because of awaiting evaluation for cardiac rehabilitation or transplantation

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).

Group Type: EXPERIMENTAL

moderate-intensity group

Intervention Type: OTHER

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) + peripheral muscle trained with exercises of upper limbs and lower limbs (50% 1 RM, increased every 2-weeks).

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).

Group Type: ACTIVE_COMPARATOR

low-intensity group

Intervention Type: OTHER

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) + peripheral muscle trained with exercises of upper limbs and lower limbs (0,5 kg each)

Interventions

control

No intervention during the 8-weeks period of the study because of awaiting evaluation for cardiac rehabilitation or transplantation

Intervention Type: OTHER

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) + peripheral muscle trained with exercises of upper limbs and lower limbs (50% 1 RM, increased every 2-weeks).

Intervention Type: OTHER

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) + peripheral muscle trained with exercises of upper limbs and lower limbs (0,5 kg each)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

Instituto Dante Pazzanese de Cardiologia

OTHER

Sponsor Role: collaborator

Naomi Kondo Nakagawa

OTHER

Sponsor Role: lead

Responsible Party

Naomi Kondo Nakagawa

Associate Professor of Medical School of Sao Paulo University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Naomi K Nakagawa, PhD

Role: PRINCIPAL_INVESTIGATOR

USP

Locations

Instituto Dante Pazzanese de Cardiologia

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

FAPESP 2013/13598-1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CEP 232/12

Identifier Type: -

Identifier Source: org_study_id