Inspiratory Muscle and Peripheral Muscle Training in Chronic Heart Failure

NCT02263482 | Completed

• 2 other identifiers: CEP 232/12FAPESP 2013/13598-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Heart Failure

Keywords

muscle training; walking test; chronic heart failure; functional capacity

Outcome Measures

Primary Outcomes (1)

• Change in respiratory muscle strength (in centimeters of water)

  Inspiratory and expiratory muscle strength was assessed by using a pressure transducer (MVD-300 Microhard System, GlobalMed, Porto Alegre, Brazil).

  Before and after 8-weeks

Secondary Outcomes (1)

• walking distance

  Before and after 8-weeks

Other Outcomes (8)

• Change in pulmonary function

  Before and after 8-weeks

• Change in functional capacity

  Before and after 8-weeks

• Inflammation in the upper airway by cytokines in blood

  Before and after 8-weeks

Study Arms (3)

Control group

OTHER

patients awaiting for evaluation to cardiac rehabilitation or transplantation

Other: control

moderate-intensity group

EXPERIMENTAL

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).

Other: moderate-intensity group

low-intensity group

ACTIVE COMPARATOR

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).

Other: low-intensity group

Interventions

control OTHER

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

Control group

moderate-intensity group 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).

moderate-intensity group

low-intensity group 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)

low-intensity group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Naomi Kondo Nakagawa: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• Instituto Dante Pazzanese de Cardiologia: collaborator

Study Sites (1)

Instituto Dante Pazzanese de Cardiologia

São Paulo, São Paulo, 04012-909, Brazil

Location

Study Officials

• Naomi K Nakagawa, PhD

  USP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medical School of Sao Paulo University

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: October 13, 2014
• Study Start: October 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 7, 2015

Record last verified: 2015-12

Locations

BR (1)