Back to resultsCardiovascular Oscillations in Coronary Patients With and Without Type 2 Diabetes
Primary Purpose
Coronary Artery Disease, Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Isometric exercise
Sponsored by
About this trial
This is an interventional other trial for Coronary Artery Disease focused on measuring Isometric Exercise, Arterial Pressure, Autonomic Nervous System, Cardiovascular system, Posture
Eligibility Criteria
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
Sites / Locations
- Universidade Federal de São Carlos
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Healthy subjects
Coronary disease with Type 2 Diabetes
Coronary disease without Type 2 Diabetes
Arm Description
15 men, 45 and 65 years old. After initial evaluation, clinical exercise testing, cardiopulmonary exercise testing, carotid ultrasound, laboratory tests (biochemical blood) and isometric exercise protocol will be performed.
15 men, 45-65 years old, with coronary artery disease and type 2 diabetes will perform clinical exercise testing, cardiopulmonary exercise testing, carotid ultrasound, laboratory tests (biochemical blood), clinical autonomic tests and isometric exercise protocol will be performed.
15 men, 45-65 years old, with coronary artery disease will perform clinical exercise testing, cardiopulmonary exercise testing, carotid ultrasound, laboratory tests (biochemical blood) and isometric exercise will be performed.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02050399
First Posted
January 16, 2014
Last Updated
January 24, 2018
Sponsor
Universidade Federal de Sao Carlos
1. Study Identification
Unique Protocol Identification Number
NCT02050399
Brief Title
Cardiovascular Oscillations in Coronary Patients With and Without Type 2 Diabetes
Official Title
Cardiovascular Oscillations at Rest and During Isometric Exercise in Coronary Patients With and Without Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Sao Carlos
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Diabetes Mellitus, Type 2
Keywords
Isometric Exercise, Arterial Pressure, Autonomic Nervous System, Cardiovascular system, Posture
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy subjects
Arm Type
Active Comparator
Arm Description
15 men, 45 and 65 years old. After initial evaluation, clinical exercise testing, cardiopulmonary exercise testing, carotid ultrasound, laboratory tests (biochemical blood) and isometric exercise protocol will be performed.
Arm Title
Coronary disease with Type 2 Diabetes
Arm Type
Experimental
Arm Description
15 men, 45-65 years old, with coronary artery disease and type 2 diabetes will perform clinical exercise testing, cardiopulmonary exercise testing, carotid ultrasound, laboratory tests (biochemical blood), clinical autonomic tests and isometric exercise protocol will be performed.
Arm Title
Coronary disease without Type 2 Diabetes
Arm Type
Experimental
Arm Description
15 men, 45-65 years old, with coronary artery disease will perform clinical exercise testing, cardiopulmonary exercise testing, carotid ultrasound, laboratory tests (biochemical blood) and isometric exercise will be performed.
Intervention Type
Other
Intervention Name(s)
Isometric exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cardiovascular responses during isometric exercise
Description
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.
Time Frame
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)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aparecida Maria Catai
Organizational Affiliation
Universidade Federal de Sao Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal de São Carlos
City
São Carlos
State/Province
São Paulo
ZIP/Postal Code
13565-905
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
21180863
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.
Results Reference
background
PubMed Identifier
22801514
Citation
Amaral JF, Mancini M, Novo Junior 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. doi: 10.1590/s1413-35552012000300007.
Results Reference
background
PubMed Identifier
10100100
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. doi: 10.1097/00004872-199917010-00015.
Results Reference
background
PubMed Identifier
20962207
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.
Results Reference
background
PubMed Identifier
21796411
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.
Results Reference
background
PubMed Identifier
21165806
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.
Results Reference
background
Learn more about this trial
Cardiovascular Oscillations in Coronary Patients With and Without Type 2 Diabetes
We'll reach out to this number within 24 hrs