The Effects of Inspiratory Muscle Training in Patients With Heart Failure With Preserved Ejection Fraction
1 other identifier
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable heart-failure
Started Mar 2011
Shorter than P25 for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 9, 2012
CompletedFirst Posted
Study publicly available on registry
October 16, 2012
CompletedFebruary 4, 2016
February 1, 2016
10 months
October 9, 2012
February 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in exercise capacity parameters at 12-weeks.
Exercise parameters: peak exercise oxygen uptake (peak VO2), 6-minutes walk test
12 weeks
Secondary Outcomes (1)
Changes in 12-week quality of life, biomarkers related to the severity and parameters of left ventricular diastolic function.
12 weeks
Study Arms (2)
Inspiratory muscle training
EXPERIMENTALInspiratory muscle training for improving maximum inspiratory pressure plus phrmacological treatment Pharmacological treatment (usual care)
Usual care
ACTIVE COMPARATORPharmacological treatment
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Clínico Universitario
Valencia, Valencia, 46010, Spain
Related Publications (3)
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.
PMID: 22993500BACKGROUNDDiaz-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.
PMID: 23918838DERIVEDPalau 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.
PMID: 23864363DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julio Núñez, MD
Hospital Clínico Universitario de Valencia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
October 9, 2012
First Posted
October 16, 2012
Study Start
March 1, 2011
Primary Completion
January 1, 2012
Study Completion
March 1, 2012
Last Updated
February 4, 2016
Record last verified: 2016-02