The Effects of Inspiratory Muscle Training in Patients With Heart Failure With Preserved Ejection Fraction
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ClinicalTrials.gov Identifier: NCT01707277 |
Recruitment Status
:
Completed
First Posted
: October 16, 2012
Last Update Posted
: February 4, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Heart Failure | Other: Inspiratory muscle training Other: Usual care | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Effects of Inspiratory Muscle Training in Patients With Heart Failure With Preserved Ejection Fraction |
Study Start Date : | March 2011 |
Actual Primary Completion Date : | January 2012 |
Actual Study Completion Date : | March 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Inspiratory muscle training
Inspiratory muscle training for improving maximum inspiratory pressure plus phrmacological treatment Pharmacological treatment (usual care)
|
Other: 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.
Other: Usual care
Usual pahramacological treatment
|
Active Comparator: Usual care
Pharmacological treatment
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Other: Usual care
Usual pahramacological treatment
|
- Changes in exercise capacity parameters at 12-weeks. [ Time Frame: 12 weeks ]Exercise parameters: peak exercise oxygen uptake (peak VO2), 6-minutes walk test
- Changes in 12-week quality of life, biomarkers related to the severity and parameters of left ventricular diastolic function. [ Time Frame: 12 weeks ]
Quality of life: Minnesota Living With Heart Failure Questionnaire. Biomarkers: plasma natriuretic peptides, estimaated glomerular filtration rate, antigen carbohydrate 125.
Diastolic function: E/e´.

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01707277
Spain | |
Hospital Clínico Universitario | |
Valencia, Spain, 46010 |
Principal Investigator: | Julio Núñez, MD | Hospital Clínico Universitario de Valencia |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Julio Nuñez, MD, PhD, University of Valencia |
ClinicalTrials.gov Identifier: | NCT01707277 History of Changes |
Other Study ID Numbers: |
EMI |
First Posted: | October 16, 2012 Key Record Dates |
Last Update Posted: | February 4, 2016 |
Last Verified: | February 2016 |
Keywords provided by Julio Nuñez, University of Valencia:
Heart failure with preserved ejection fraction Inspiratory muscle training Exercise capacity |
Additional relevant MeSH terms:
Heart Failure Respiratory Aspiration Heart Diseases Cardiovascular Diseases |
Respiration Disorders Respiratory Tract Diseases Pathologic Processes |