Inspiratory Muscle and Peripheral Muscle Training in Chronic Heart Failure

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

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).

Study Overview

• Status: Completed
• Conditions: Chronic Heart Failure
• Intervention / Treatment: Other: control; Other: moderate-intensity group; Other: low-intensity group

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 04012-909
    • Instituto Dante Pazzanese de Cardiologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group; patients awaiting for evaluation to cardiac rehabilitation or transplantation	Other: control; No intervention during the 8-weeks period of the study because of awaiting evaluation for cardiac rehabilitation or transplantation
Experimental: 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).	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).
Active Comparator: 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).	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pulmonary function	Pulmonary function will be assessed by spirometry.	Before and after 8-weeks
Change in functional capacity	1RM	Before and after 8-weeks
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
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
Prevalence of cardiac events and arrhythmia	by a 24-hours holter system for continuous recording of ambulatory electrocardiographic signs	Before and after 8-weeks
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
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
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

Collaborators and Investigators

• Sponsor: Naomi Kondo Nakagawa
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo; Instituto Dante Pazzanese de Cardiologia
• Investigators: Principal Investigator: Naomi K Nakagawa, PhD, USP

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: September 29, 2014
• First Submitted That Met QC Criteria: October 10, 2014
• First Posted (Estimate): October 13, 2014

Study Record Updates

• Last Update Posted (Estimate): December 7, 2015
• Last Update Submitted That Met QC Criteria: December 4, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: functional capacity; chronic heart failure; muscle training; walking test
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CEP 232/12; FAPESP 2013/13598-1 (Other Grant/Funding Number: FAPESP 2013/13598-1)