The Effects of Inspiratory Muscle Training in Patients With Heart Failure With Preserved Ejection Fraction
This study has been completed.
Sponsor:
Fundación para la Investigación del Hospital Clínico de Valencia
Collaborator:
University of Valencia
Information provided by (Responsible Party):
Julio Nuñez, University of Valencia
ClinicalTrials.gov Identifier:
NCT01707277
First received: October 9, 2012
Last updated: February 3, 2016
Last verified: February 2016
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Heart Failure |
Other: Inspiratory muscle training Other: Usual care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Effects of Inspiratory Muscle Training in Patients With Heart Failure With Preserved Ejection Fraction |
Resource links provided by NLM:
Further study details as provided by Fundación para la Investigación del Hospital Clínico de Valencia:
Primary Outcome Measures:
- Changes in exercise capacity parameters at 12-weeks. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Exercise parameters: peak exercise oxygen uptake (peak VO2), 6-minutes walk test
Secondary Outcome Measures:
- Changes in 12-week quality of life, biomarkers related to the severity and parameters of left ventricular diastolic function. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Quality of life: Minnesota Living With Heart Failure Questionnaire. Biomarkers: plasma natriuretic peptides, estimaated glomerular filtration rate, antigen carbohydrate 125.
Diastolic function: E/e´.
| Enrollment: | 26 |
| Study Start Date: | March 2011 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Other: Usual care
Usual pahramacological treatment
|
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01707277
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707277
Locations
| Spain | |
| Hospital Clínico Universitario | |
| Valencia, Spain, 46010 | |
Sponsors and Collaborators
Fundación para la Investigación del Hospital Clínico de Valencia
University of Valencia
Investigators
| Principal Investigator: | Julio Núñez, MD | Hospital Clínico Universitario de Valencia |
More Information
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 |
| Study First Received: | October 9, 2012 |
| Last Updated: | February 3, 2016 |
| Health Authority: | Spain: Ethics Committee |
Keywords provided by Fundación para la Investigación del Hospital Clínico de 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 |
ClinicalTrials.gov processed this record on September 23, 2016