Clinical trial NCT02263482: Inspiratory Muscle and Peripheral Muscle Training in Chronic Heart Failure
Official title: Inspiratory Muscle and Peripheral Muscle Combined Training Effects on the Respiratory and Functional Capacity and Quality of Life in Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Heart Failure
Keywords: muscle training
walking test
chronic heart failure
functional capacity
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Instituto Dante Pazzanese de Cardiologia
First posted: 2014-10-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in respiratory muscle strength (in centimeters of water)
timeFrame: Before and after 8-weeks
Secondary outcomes:
measure: walking distance
timeFrame: Before and after 8-weeks
Other outcomes:
measure: Change in pulmonary function
timeFrame: Before and after 8-weeks
measure: Change in functional capacity
timeFrame: Before and after 8-weeks
measure: Inflammation in the upper airway by cytokines in blood
timeFrame: Before and after 8-weeks
measure: Change in heart rate variability (HRV)
timeFrame: Before and after 8-weeks
measure: Prevalence of cardiac events and arrhythmia
timeFrame: Before and after 8-weeks
measure: Change in international Physical Activity Questionnaire (IPAQ)
timeFrame: Before and after 8-weeks
measure: Change in quality of life using Minnesota Questionnaire
timeFrame: Before and after 8-weeks
measure: Change in brain natriuretic peptide (BNP) analysis
timeFrame: Before and after 8-weeks
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiologia
Study officials:
affiliation: USP
name: Naomi K Nakagawa, PhD
role: PRINCIPAL_INVESTIGATOR
References: