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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02263482
Enrollment
30
Registered
2014-10-13
Start date
2012-10-31
Completion date
2015-12-31
Last updated
2015-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Heart Failure

Keywords

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

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.

Interventions

OTHERcontrol

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

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).

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)

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
Instituto Dante Pazzanese de Cardiologia
CollaboratorOTHER
Naomi Kondo Nakagawa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in respiratory muscle strength (in centimeters of water)Before and after 8-weeksInspiratory and expiratory muscle strength was assessed by using a pressure transducer (MVD-300 Microhard System, GlobalMed, Porto Alegre, Brazil).

Secondary

MeasureTime frameDescription
walking distanceBefore and after 8-weeksTo assess functional capacity using walking distance (6-min walk test accordingly to ATS and ERS guidelines)

Other

MeasureTime frameDescription
Inflammation in the upper airway by cytokines in bloodBefore and after 8-weeksMMP2, 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.
Change in heart rate variability (HRV)Before and after 8-weeksHRV is obtained from the spectral analysis of R-R intervals obtained from a heart rate monitor (Polar, S810, Kempele, Finland)
Prevalence of cardiac events and arrhythmiaBefore and after 8-weeksby a 24-hours holter system for continuous recording of ambulatory electrocardiographic signs
Change in pulmonary functionBefore and after 8-weeksPulmonary function will be assessed by spirometry.
Change in quality of life using Minnesota QuestionnaireBefore and after 8-weeksby 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.
Change in brain natriuretic peptide (BNP) analysisBefore and after 8-weeksA blood sample of 5 ml will be collected in a tube and BNP measured
Change in international Physical Activity Questionnaire (IPAQ)Before and after 8-weeksPatients will be classified as sedentary, irregularly active, active or verry active according to Matsudo's classification (2001).
Change in functional capacityBefore and after 8-weeks1RM

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026