The Effects of Inspiratory Muscle Training in Patients With Heart Failure With Preserved Ejection Fraction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-03-31

Brief Summary

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Previous studies have evaluated the effects of inspiratory muscle training in patiens with heart failure and reduced ejection fraction; nevertheless,no evidence endorse the therapeutic role of inspiratory muscle training in patients with heart failure and preserved ejection fraction. The investigators sought to evaluate whether 12-week inspiratory muscle training improves exercise capacity (peak exercise oxygen uptake and 6-minutes walk test), as well as left ventricular diastolic function, serum biomarkers and quality of life (Minnesota Living With Heart Failure Questionnaire) in patients with heart failure with preserved ejection fraction and non-reduced inspiratory muscle strength.

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Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Inspiratory muscle training

Inspiratory muscle training for improving maximum inspiratory pressure plus phrmacological treatment Pharmacological treatment (usual care)

Group Type EXPERIMENTAL

Inspiratory muscle training

Intervention Type OTHER

Patients were instructed to train at home twice daily for 20 minutes each session during 12 weeks with a threshold inspiratory muscle trainer (Threshold IMT®, Respironics Inc.). All of them were trained under the supervision of a physiotherapist and educated to maintain diaphragmatic breathing during training. The subjects started breathing at a resistance equal to 25-30% of their maximum inspiratory pressure for 1 week.

Usual care

Intervention Type OTHER

Usual pahramacological treatment

Usual care

Pharmacological treatment

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

Usual pahramacological treatment

Interventions

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Inspiratory muscle training

Patients were instructed to train at home twice daily for 20 minutes each session during 12 weeks with a threshold inspiratory muscle trainer (Threshold IMT®, Respironics Inc.). All of them were trained under the supervision of a physiotherapist and educated to maintain diaphragmatic breathing during training. The subjects started breathing at a resistance equal to 25-30% of their maximum inspiratory pressure for 1 week.

Intervention Type OTHER

Usual care

Usual pahramacological treatment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* a) previous history of symptomatic heart failure (New York Heart Association \[NYHA\] functional class ≥II)
* b) evidence of normal left ventricular ejection fraction, defined by an ejection fraction \>0.50 and an end-diastolic diameter \<60 mm by 2D echocardiography
* c) relevant structural heart disease (left ventricle hypertrophy/left atrial enlargement) and/or diastolic dysfunction estimated by 2D echocardiography
* d) clinical stability, including no admissions in the past 30 days

Exclusion Criteria

* a) Patients unable to perform a valid baseline exercise test.
* b) Unstable angina, myocardial infarction or cardiac surgery within the previous three months.
* c)Known chronic metabolic, orthopedic, infectious disease or previous pulmonary disease;
* d)Treatment with steroids, hormones, or cancer chemotherapy;
* e)Reduced maximal inspiratory pressure according to age and sex;
* f)Active smokers
* g)Acute decompensation;
* h)Other comorbidity with an expectancy of life less than one year

Eligible Sex

ALL

Accepts Healthy Volunteers

No