Inspiratory Muscle and Peripheral Muscle Training in Chronic Heart Failure

Chronic Heart Failure Clinical Trial

Official title:

Inspiratory Muscle and Peripheral Muscle Combined Training Effects on the Respiratory and Functional Capacity and Quality of Life in Chronic Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02263482
• Other study ID #: CEP 232/12
• Secondary ID: FAPESP 2013/1359
• Status: Completed
• Phase: N/A
• First received: September 29, 2014
• Last updated: December 4, 2015
• Start date: October 2012
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Brazil	Instituto Dante Pazzanese de Cardiologia	Sao Paulo

Sponsors (3)

Lead Sponsor	Collaborator
Naomi Kondo Nakagawa	Fundação de Amparo à Pesquisa do Estado de São Paulo, Instituto Dante Pazzanese de Cardiologia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in pulmonary function	Pulmonary function will be assessed by spirometry.	Before and after 8-weeks
Other	Change in functional capacity	1RM	Before and after 8-weeks
Other	Inflammation in the upper airway by cytokines in blood	MMP2, myoglobin, p-selectin, MPO, NGAL, sVCAM, IL-2, IL-3, IL-4, IL-8,MIP1-alpha, 17, VEGF by Multiplex analysis. Inflammatory cells in nasal lavage will be also investigated.	Before and after 8-weeks
Other	Change in heart rate variability (HRV)	HRV is obtained from the spectral analysis of R-R intervals obtained from a heart rate monitor (Polar, S810, Kempele, Finland)	Before and after 8-weeks
Other	Prevalence of cardiac events and arrhythmia	by a 24-hours holter system for continuous recording of ambulatory electrocardiographic signs	Before and after 8-weeks
Other	Change in international Physical Activity Questionnaire (IPAQ)	Patients will be classified as sedentary, irregularly active, active or verry active according to Matsudo`s classification (2001).	Before and after 8-weeks
Other	Change in quality of life using Minnesota Questionnaire	by Short Form-36 and by Minnesota Living with Heart Failure Questionnaire; - Minnesota living with heart failure questionaire: contains 21 questions of physical, social, economic and emotional aspects. Each question ranges from zero to five points, with a total score of 105 points which is the maximum severity degree related to personal perception of quality of life.	Before and after 8-weeks
Other	Change in brain natriuretic peptide (BNP) analysis	A blood sample of 5 ml will be collected in a tube and BNP measured	Before and after 8-weeks
Primary	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	walking distance	To assess functional capacity using walking distance (6-min walk test accordingly to ATS and ERS guidelines)	Before and after 8-weeks