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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01707277
• Other study ID #: EMI
• Status: Completed
• Phase: N/A
• First received: October 9, 2012
• Last updated: February 3, 2016
• Start date: March 2011
• Est. completion date: March 2012

Study information

• Verified date: February 2016
• Source: Fundación para la Investigación del Hospital Clínico de Valencia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Respiratory Aspiration

Intervention

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.
• Usual care
Usual pahramacological treatment

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Fundación para la Investigación del Hospital Clínico de Valencia	University of Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Lin SJ, McElfresh J, Hall B, Bloom R, Farrell K. Inspiratory muscle training in patients with heart failure: a systematic review. Cardiopulm Phys Ther J. 2012 Sep;23(3):29-36. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in exercise capacity parameters at 12-weeks.	Exercise parameters: peak exercise oxygen uptake (peak VO2), 6-minutes walk test	12 weeks	No
Secondary	Changes in 12-week quality of life, biomarkers related to the severity and parameters of left ventricular diastolic function.	Quality of life: Minnesota Living With Heart Failure Questionnaire. Biomarkers: plasma natriuretic peptides, estimaated glomerular filtration rate, antigen carbohydrate 125.; Diastolic function: E/e´.	12 weeks	No