Cardiac Function and Inspiratory Muscles Performance

Heart Failure Clinical Trial

Official title:

Correlation Between Cardiac Function and Inspiratory Muscles Performance, Chest Wall Volumes and Quality of Life in Individuals With Heart Failure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02763982
• Other study ID #: 39797414.2.0000.520
• Status: Not yet recruiting
• Phase: N/A
• First received: May 2, 2016
• Last updated: May 4, 2016
• Start date: May 2016
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Universidade Federal de Pernambuco
• Contact: Peterson Filipe Pinheiro de Lima, Graduated
• Phone: +5581998186292
• Email: pinheirofilipe[@]live.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Will be included individuals diagnosed with heart failure, both sexes, aged 18-65 years;

• hemodynamically stable (SBP = 140 mmHg; DBP = 90 mmHg; HR = 80 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.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Physical evaluation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

References & Publications (4)

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 patie — View 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. — View Citation

Verissimo P, Casalaspo TJ, Gonçalves 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. eCollect — View 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):3 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between left ventricular ejection fraction and peak oxygen uptake on inspiratory muscle strength as assessed by echocardiography, ergospirometer and mouth pressure maneuver, respectively		through study completion, an average of 6 months	Yes
Secondary	Correlation between left ventricular ejection fraction and peak oxygen uptake on chest wall volumes as assessed by echocardiography, ergospirometer and opto-electronic plethysmography, respectively		through study completion, an average of 6 months	Yes
Secondary	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		through study completion, an average of 6 months	Yes