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CompletedNCT02050399Updated Jan 26, 2018

Cardiovascular Oscillations in Coronary Patients With and Without Type 2 Diabetes

An interventional study of Isometric exercise in Coronary Artery Disease and Diabetes Mellitus, Type 2, sponsored by Universidade Federal de Sao Carlos. Completed at 1 site in Brazil. Open to male participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-26.

Sponsored by Universidade Federal de Sao Carlos · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
45 Years to 65 Years
Sex
Male
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Study 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.

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Conditions studied

  • Coronary Artery Disease
  • Diabetes Mellitus, Type 2

Keywords

  • Isometric Exercise
  • Arterial Pressure
  • Autonomic Nervous System
  • Cardiovascular system
  • Posture
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In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 30 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Universidade Federal de Sao Carlos is the lead sponsor of 85 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Participant)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    Healthy subjects

    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.

    Other: Isometric exercise

  • Experimental
    Coronary disease with Type 2 Diabetes

    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.

    Other: Isometric exercise

  • Experimental
    Coronary disease without Type 2 Diabetes

    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.

    Other: Isometric exercise

Interventions

  • OtherIsometric 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.

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What researchers measure

Primary outcomes

  1. 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.

    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)

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Study locations

1 site
  • Universidade Federal de São Carlos
    São Carlos, São Paulo 13565-905, Brazil
08

References and documents

Publications

  • 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. PubMed 21180863 ↗
  • 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. PubMed 22801514 ↗
  • 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. PubMed 10100100 ↗
  • 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. PubMed 20962207 ↗
  • 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. PubMed 21796411 ↗
  • 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. PubMed 21165806 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02050399
Lead sponsor
Universidade Federal de Sao Carlos
Responsible party
Aparecida Maria Catai (Cardiovascular oscillations at rest and during isometric exercise in coronary patients with and without type 2 diabetes, Universidade Federal de Sao Carlos) — Principal investigator
First posted
Jan 30, 2014
Start date
Aug 2013
Primary completion
Dec 2015
Completion
Mar 2016
Last update
Jan 26, 2018

Study contacts

Aparecida Maria Catai
principal investigator · Universidade Federal de Sao Carlos

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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