Clinical trial NCT02763982: Cardiac Function and Inspiratory Muscles Performance
Official title: Correlation Between Cardiac Function and Inspiratory Muscles Performance, Chest Wall Volumes and Quality of Life in Individuals With Heart Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Keywords: left ventricular ejection fraction
peak oxygen uptake
respiratory muscles
quality of life
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Both female and male participants are being studied, between 18 to 65 years old, diagnosed with heart failure.

Brief summary: The purpose of this study is to determine whether ejection fraction and peak oxygen uptake have correlation on inspiratory muscle strength, chest wall volumes and quality of life in individuals with heart failure.


Eligibility criteria: Inclusion Criteria:

* Will be included individuals diagnosed with heart failure, both sexes, aged 18-65 years;
* hemodynamically stable (systolic blood pressure ≤ 140 mmHg; diastolic blood pressure ≤ 90 mmHg; heart rate = 90 bpm);
* self-reported sedentary.

Exclusion Criteria:

* Will be excluded individuals with unstable angina were excluded;
* acute myocardial infarction or previous surgery up to three months before the survey;
* musculoskeletal changes, respiratory or chronic metabolic diseases;
* treatment with steroids, hormones or chemotherapy;
* gestation;
* smokers and former smokers assets or liabilities;
* inability to comply with verbal commands appraiser or unsuitability to the evaluation devices.

Primary outcomes:
measure: Correlation between left ventricular ejection fraction and peak oxygen uptake on inspiratory muscle strength as assessed by echocardiography, ergospirometer and mouth pressure maneuver, respectively
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Correlation between left ventricular ejection fraction and peak oxygen uptake on chest wall volumes as assessed by echocardiography, ergospirometer and opto-electronic plethysmography, respectively
timeFrame: through study completion, an average of 6 months
measure: Correlation between left ventricular ejection fraction and peak oxygen uptake on quality of life as assessed by echocardiography, ergospirometer and Minnesota Living with Heart Failure Questionnaire, respectively
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: Yamada K, Kinugasa Y, Sota T, Miyagi M, Sugihara S, Kato M, Yamamoto K. Inspiratory Muscle Weakness is Associated With Exercise Intolerance in Patients With Heart Failure With Preserved Ejection Fraction: A Preliminary Study. J Card Fail. 2016 Jan;22(1):38-47. doi: 10.1016/j.cardfail.2015.10.010. Epub 2015 Oct 23.
citation: Verissimo P, Casalaspo TJ, Goncalves LH, Yang AS, Eid RC, Timenetsky KT. High prevalence of respiratory muscle weakness in hospitalized acute heart failure elderly patients. PLoS One. 2015 Feb 11;10(2):e0118218. doi: 10.1371/journal.pone.0118218. eCollection 2015.
citation: Adamopoulos S, Schmid JP, Dendale P, Poerschke D, Hansen D, Dritsas A, Kouloubinis A, Alders T, Gkouziouta A, Reyckers I, Vartela V, Plessas N, Doulaptsis C, Saner H, Laoutaris ID. Combined aerobic/inspiratory muscle training vs. aerobic training in patients with chronic heart failure: The Vent-HeFT trial: a European prospective multicentre randomized trial. Eur J Heart Fail. 2014 May;16(5):574-82. doi: 10.1002/ejhf.70. Epub 2014 Mar 14.
citation: Stamm O, Latscha U, Janecek P, Campana A. Development of a special electrode for continuous subcutaneous pH measurement in the infant scalp. Am J Obstet Gynecol. 1976 Jan 15;124(2):193-5. doi: 10.1016/s0002-9378(16)33297-5.