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Completed

NCT Number: NCT02263482

Inspiratory Muscle and Peripheral Muscle Training 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).

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Key information

Conditions

Chronic Heart Failure

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Dante Pazzanese de Cardiologia

São Paulo, 04012-909, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Other

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

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).

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)

Primary outcomes

  1. Change in respiratory muscle strength (in centimeters of water)

    Time frame: Before and after 8-weeks

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

Secondary outcomes

  1. walking distance

    Time frame: Before and after 8-weeks

    To assess functional capacity using walking distance (6-min walk test accordingly to ATS and ERS guidelines)

Other outcomes

  1. Change in pulmonary function

    Time frame: Before and after 8-weeks

    Pulmonary function will be assessed by spirometry.

  2. Change in functional capacity

    Time frame: Before and after 8-weeks

    1RM

  3. Inflammation in the upper airway by cytokines in blood

    Time frame: Before and after 8-weeks

    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.

  4. Change in heart rate variability (HRV)

    Time frame: Before and after 8-weeks

    HRV is obtained from the spectral analysis of R-R intervals obtained from a heart rate monitor (Polar, S810, Kempele, Finland)

  5. Prevalence of cardiac events and arrhythmia

    Time frame: Before and after 8-weeks

    by a 24-hours holter system for continuous recording of ambulatory electrocardiographic signs

  6. Change in international Physical Activity Questionnaire (IPAQ)

    Time frame: Before and after 8-weeks

    Patients will be classified as sedentary, irregularly active, active or verry active according to Matsudo's classification (2001).

  7. Change in quality of life using Minnesota Questionnaire

    Time frame: Before and after 8-weeks

    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.

  8. Change in brain natriuretic peptide (BNP) analysis

    Time frame: Before and after 8-weeks

    A blood sample of 5 ml will be collected in a tube and BNP measured

Sponsors and collaborators

Lead sponsor

Naomi Kondo Nakagawa

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo
  • Instituto Dante Pazzanese de Cardiologia

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 13, 2014
Registry last updated
Dec 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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