Cardiovascular Oscillations in Coronary Patients With and Without Type 2 Diabetes

Coronary Artery Disease Clinical Trial

Official title:

Cardiovascular Oscillations at Rest and During Isometric Exercise in Coronary Patients With and Without Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02050399
• Other study ID #: 13287613.0.0000.5504
• Status: Completed
• Phase: N/A
• First received: January 16, 2014
• Last updated: January 24, 2018
• Start date: August 2013
• Est. completion date: March 2016

Study information

• Verified date: January 2014
• Source: Universidade Federal de Sao Carlos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Coronary artery disease (CAD) and diabetes mellitus (DM) may promote alterations in heart responses during exercise or postural maneuver. Thus, the purpose of this study is to observe the influence of different postures (supine, seated and standing) and different percentages (15, 30, 45 and 60%) of the maximum voluntary contraction (MVC) of handgrip in the responses of heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), cardiac output (CO), stroke volume (SV) and peripheral vascular resistance (PVR) in coronary patients with and without type 2 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 65 Years

Eligibility

Inclusion Criteria:

• coronary artery disease

• clinical diagnosis of type 2 diabetes

• free of type 2 diabetes to participate of control group and coronary disease without Type 2 Diabetes group

• nonsmokers

• not alcoholics

Exclusion Criteria:

• autonomic neuropathy

• clinical exercise testing with ECG alterations (ST-segment depression greater than 2 mm, ventricular and supraventricular arrhythmias, sustained or non-sustained supraventricular tachycardia, atrial tachycardia, atrial fibrillation and atrioventricular blocks) or symptom of angina induced by stress.

• Individuals with hypertension and diabetes mellitus not controlled.

• Subjects who did not complete all assessments.

• Subjects with temporal (R-Ri and pressure) series with noise preventing the evaluation

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Myocardial Ischemia

Intervention

Other:
• Isometric exercise
The isometric protocol (handgrip) will be performed into 4 percentages of MVC (15, 30, 45 and 60%) to exhaustion in 3 postures (supine, seated and standing position). The percentages and the postures will be randomized. In the first day of exercise protocol the subjects will be at rest during 10 minutes and will perform 3 MVC during 5 seconds, with 5 minutes of recovery. The higher value of MVC will be used to prescribe the percentages. The subjects will perform two contractions until exhaustion in one posture in each day.

Locations

Country	Name	City	State
Brazil	Universidade Federal de São Carlos	São Carlos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Sao Carlos

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

Amaral JF, Mancini M, Novo Júnior JM. Comparison of three hand dynamometers in relation to the accuracy and precision of the measurements. Rev Bras Fisioter. 2012 Jun;16(3):216-24. — View Citation

Krzeminski K, Cybulski G, Ziemba A, Nazar K. Cardiovascular and hormonal responses to static handgrip in young and older healthy men. Eur J Appl Physiol. 2012 Apr;112(4):1315-25. doi: 10.1007/s00421-011-2069-y. Epub 2011 Jul 28. — View Citation

Legramante JM, Massaro M, Raimondi G, Castrucci F, Cassarino S, Peruzzi G, Iellamo F. Effect of postural changes on cardiovascular responses to static exercise in hypertensive human beings. J Hypertens. 1999 Jan;17(1):99-105. — View Citation

Leite PH, Melo RC, Mello MF, Silva Ed, Borghi-Silva A, Catai AM. Heart rate responses during isometric exercises in patients undergoing a phase III cardiac rehabilitation program. Rev Bras Fisioter. 2010 Sep-Oct;14(5):383-9. English, Portuguese. — View Citation

Millar PJ, MacDonald MJ, McCartney N. Effects of isometric handgrip protocol on blood pressure and neurocardiac modulation. Int J Sports Med. 2011 Mar;32(3):174-80. doi: 10.1055/s-0030-1268473. Epub 2010 Dec 16. — View Citation

Porta A, Catai AM, Takahashi AC, Magagnin V, Bassani T, Tobaldini E, van de Borne P, Montano N. Causal relationships between heart period and systolic arterial pressure during graded head-up tilt. Am J Physiol Regul Integr Comp Physiol. 2011 Feb;300(2):R378-86. doi: 10.1152/ajpregu.00553.2010. Epub 2010 Oct 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular responses during isometric exercise	15 men with coronary artery disease and 15 healthy subjects will perform isometric contractions (handgrip) in different percentages (15,30, 45 60%) of maximum voluntary contraction (MVC) and in different postures (supine, seated and standing position). The percentages and postures will be randomized and the subjects will perform two contractions per day in a posture. All the variables will be evaluated through pulse plethysmograph (Finometer PRO, Finapress Medical System, The Netherlands). The subjects will be assessed in the protocol of isometric exercise for six days (two contractions per day and one posture). Initially they will remain at rest for 10 minutes and wiil perform the percentage drawn of maximal voluntary contraction until exhaustion. After 10 minutes of recovery subjects will perform another percentage of maximum contraction to exhaustion.	Change in heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, cardiac output, stroke volume and peripheral resistance. [time frame: initial (10 min), during the time of contraction (peak) and after contraction (10 min)