- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02763982
Cardiac Function and Inspiratory Muscles Performance
May 4, 2016 updated by: Peterson Filipe Pinheiro de Lima, Universidade Federal de Pernambuco
Correlation Between Cardiac Function and Inspiratory Muscles Performance, Chest Wall Volumes and Quality of Life in Individuals With Heart Failure
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.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
24
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Peterson Filipe Pinheiro de Lima, Graduated
- Phone Number: +5581998186292
- Email: pinheirofilipe@live.com
Study Contact Backup
- Name: Armèle de Fátima Dornelas de Andrade, PhD
- Phone Number: +558121268491
- Email: armeledornelas@yahoo.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Both female and male participants are being studied, between 18 to 65 years old, diagnosed with heart failure.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
G1
High or normal left ventricular ejection fraction
|
|
G2
Moderate left ventricular ejection fraction
|
|
G3
Reduced left ventricular ejection fraction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlation between left ventricular ejection fraction and peak oxygen uptake on inspiratory muscle strength as assessed by echocardiography, ergospirometer and mouth pressure maneuver, respectively
Time Frame: through study completion, an average of 6 months
|
through study completion, an average of 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlation between left ventricular ejection fraction and peak oxygen uptake on chest wall volumes as assessed by echocardiography, ergospirometer and opto-electronic plethysmography, respectively
Time Frame: through study completion, an average of 6 months
|
through study completion, an average of 6 months
|
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
Time Frame: through study completion, an average of 6 months
|
through study completion, an average of 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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. Erratum In: PLoS One. 2015;10(4):e0124855.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2016
Primary Completion (Actual)
May 1, 2016
Study Completion (Anticipated)
May 1, 2016
Study Registration Dates
First Submitted
May 2, 2016
First Submitted That Met QC Criteria
May 4, 2016
First Posted (Estimate)
May 5, 2016
Study Record Updates
Last Update Posted (Estimate)
May 5, 2016
Last Update Submitted That Met QC Criteria
May 4, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 39797414.2.0000.520
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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