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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Inspiratory muscle training
Usual care
Sponsored by
Fundación para la Investigación del Hospital Clínico de Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart failure with preserved ejection fraction, Inspiratory muscle training, Exercise capacity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Clínico Universitario

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Inspiratory muscle training

Usual care

Arm Description

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

Pharmacological treatment

Outcomes

Primary Outcome Measures

Changes in exercise capacity parameters at 12-weeks.
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.
Quality of life: Minnesota Living With Heart Failure Questionnaire. Biomarkers: plasma natriuretic peptides, estimaated glomerular filtration rate, antigen carbohydrate 125. Diastolic function: E/e´.

Full Information

First Posted
October 9, 2012
Last Updated
February 3, 2016
Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia
Collaborators
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT01707277
Brief Title
The Effects of Inspiratory Muscle Training in Patients With Heart Failure With Preserved Ejection Fraction
Official Title
The Effects of Inspiratory Muscle Training in Patients With Heart Failure With Preserved Ejection Fraction
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia
Collaborators
University of Valencia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure with preserved ejection fraction, Inspiratory muscle training, Exercise capacity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julio Núñez, MD
Organizational Affiliation
Hospital Clínico Universitario de Valencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínico Universitario
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
22993500
Citation
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.
Results Reference
background
PubMed Identifier
23918838
Citation
Diaz-Buschmann I, Jaureguizar KV, Calero MJ, Aquino RS. Programming exercise intensity in patients on beta-blocker treatment: the importance of choosing an appropriate method. Eur J Prev Cardiol. 2014 Dec;21(12):1474-80. doi: 10.1177/2047487313500214. Epub 2013 Aug 5.
Results Reference
derived
PubMed Identifier
23864363
Citation
Palau P, Dominguez E, Nunez E, Schmid JP, Vergara P, Ramon JM, Mascarell B, Sanchis J, Chorro FJ, Nunez J. Effects of inspiratory muscle training in patients with heart failure with preserved ejection fraction. Eur J Prev Cardiol. 2014 Dec;21(12):1465-73. doi: 10.1177/2047487313498832. Epub 2013 Jul 17.
Results Reference
derived

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

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