Optoelectronic Pletysmography and Diaphragmatic Thickness in Heart Failure Patients

NCT ID: NCT02481388

Last Updated: 2015-06-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 14 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-05-31

Brief Summary

The investigators aimed to evaluate the effects of cardiomegaly associated with inspiratory muscle weakness on tricompartmental distribution of chest wall volumes, on the thickness of the right hemidiaphragm and on the contraction speed of the respiratory muscles. As method of the present research, a pilot cross-sectional study was conducted with fourteen (14) patients with heart failure, functional class II and III, clinically stable, with cardiomegaly. Two groups were formed: one group with inspiratory muscle weakness (WG) (maximal inspiratory pressure - MIP <70% predicted MIP) and a control group without weakness (CG). The pulmonary and respiratory muscle functions were assessed by spirometry and manometer, respectively. Before and after maximal exercise test, optoelectronic plethysmography was performed to evaluate the distribution of volumes, the kinematics and the contraction speed of chest wall muscles. The high-resolution ultrasonography was also used before and after the maximum test for obtaining diaphragmatic thickness

Conditions

Heart Failure

Study Design

• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Weakness Group (WG)

Patients with heart failure and a maximum inspiratory pressure (MIP) \<70% of predicted MIP to age, considered as inspiratory muscle weakness. Following the recruitment process, these volunteers will be evaluated by spirometry and manovacuometry. Afterwards, volunteers will be also assessed in a maximal exercise ramp test. Before and after the ramp test, the optoelectronic pletysmography will be performed to analyse the chest wall tricompartmental distribution and the shortening velocities of rib cages muscles. Also a high-definition ultrasonography will be performed to measure the right diaphragmatic cupule thickness

Maximal exercise ramp test

Intervention Type: OTHER

The maximal exercise ramp test, symptom-limited, performed by all patients in the study was performed based on treadmill ramp protocol through ErgoPC Elite® software associated with 12-channels electrocardiogram. Respiratory variables were obtained in standard conditions of temperature, pressure and humidity (StPD), breath-by-breath, with the patient breathing through a face mask without leaks coupled to gas analyzer (Cortex - Metamax 3B, Germany).To ensure that patients reached maximum effort during the examination, only the tests which patients obtain a respiratory exchange ratio (RR) ≥1.1 were accepted .

Control group (CG)

Patients with heart failure and do not have a maximum inspiratory pressure (MIP) \> 70% of predicted MIP to age, considered as inspiratory muscle weakness. Following the recruitment process, these volunteers will be evaluated by spirometry and manovacuometry. Afterwards, volunteers will be also assessed in a maximal exercise ramp test. Before and after the ramp test, the optoelectronic pletysmography will be performed to analyse the chest wall tricompartmental distribution and the shortening velocities of rib cages muscles. Also a high-definition ultrasonography will be performed to measure the right diaphragmatic cupule thickness

Maximal exercise ramp test

Intervention Type: OTHER

The maximal exercise ramp test, symptom-limited, performed by all patients in the study was performed based on treadmill ramp protocol through ErgoPC Elite® software associated with 12-channels electrocardiogram. Respiratory variables were obtained in standard conditions of temperature, pressure and humidity (StPD), breath-by-breath, with the patient breathing through a face mask without leaks coupled to gas analyzer (Cortex - Metamax 3B, Germany).To ensure that patients reached maximum effort during the examination, only the tests which patients obtain a respiratory exchange ratio (RR) ≥1.1 were accepted .

Interventions

Maximal exercise ramp test

The maximal exercise ramp test, symptom-limited, performed by all patients in the study was performed based on treadmill ramp protocol through ErgoPC Elite® software associated with 12-channels electrocardiogram. Respiratory variables were obtained in standard conditions of temperature, pressure and humidity (StPD), breath-by-breath, with the patient breathing through a face mask without leaks coupled to gas analyzer (Cortex - Metamax 3B, Germany).To ensure that patients reached maximum effort during the examination, only the tests which patients obtain a respiratory exchange ratio (RR) ≥1.1 were accepted .

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Both sexes, 18-60 years;
• Functional Class II-III according to the New York Heart Association;
• Echocardiography of the last six months showing showing left ventricular ejection fraction (LVEF) ≤ 45% measured by Teichholz method;
• Echocardiography the last six months showing cardiac hypertrophy (Diameter of Left Ventricular Diastolic (LVDD)> 54 mm, diameter of Systolic Left Ventricular (LVSD)> 34mm) 30 measured by Teichholz method;
• Optimized by the medical point of view and
• Clinical stability

Exclusion Criteria

• Unstable angina; myocardial infarction or heart surgery up to three months before the survey;
• Orthopedic diseases, infectious or chronic metabolic diseases;
• The relation between forced expiratory volume in the first second and forced vital capacity (FEV1 / FVC) <70% of predicted characterizing obstructive respiratory disorder and
• Active smokers.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal de Pernambuco

OTHER

Sponsor Role: lead

Responsible Party

Daniella Cunha Brandao

dbrandao

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jasiel F do Nascimento Junior, Bch

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Pernambuco

Locations

Laboratório de Fisiologia e Fisioterapia Cardiopulmonar

Recife, Pernambuco, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Daniella C Brandao, PhD

Role: CONTACT

daniellacunha@hotmail.com

+558121268496

Armele F Dornelas de Andrade, PhD

Role: CONTACT

armeledornelas@yahoo.com

+558121268496

Facility Contacts

Daniella C Brandão, PhD

Role: primary

daniellacunha@hotmail.com

+558121268496

References

Chiappa GR, Roseguini BT, Vieira PJ, Alves CN, Tavares A, Winkelmann ER, Ferlin EL, Stein R, Ribeiro JP. Inspiratory muscle training improves blood flow to resting and exercising limbs in patients with chronic heart failure. J Am Coll Cardiol. 2008 Apr 29;51(17):1663-71. doi: 10.1016/j.jacc.2007.12.045.

Reference Type: BACKGROUND

PMID: 18436118 (View on PubMed)

Brandao DC, Lage SM, Britto RR, Parreira VF, de Oliveira WA Jr, Martins SM, Aliverti A, de Andrade Carvalho L, do Nascimento Junior JF, Alcoforado L, Remigio I, de Andrade AD. Chest wall regional volume in heart failure patients during inspiratory loaded breathing. Respir Physiol Neurobiol. 2012 Mar 15;180(2-3):269-74. doi: 10.1016/j.resp.2011.12.002. Epub 2011 Dec 13.

Reference Type: RESULT

PMID: 22193337 (View on PubMed)

Aliverti A, Cala SJ, Duranti R, Ferrigno G, Kenyon CM, Pedotti A, Scano G, Sliwinski P, Macklem PT, Yan S. Human respiratory muscle actions and control during exercise. J Appl Physiol (1985). 1997 Oct;83(4):1256-69. doi: 10.1152/jappl.1997.83.4.1256.

Reference Type: RESULT

PMID: 9338435 (View on PubMed)

Other Identifiers

jasiel02

Identifier Type: -

Identifier Source: org_study_id