Coronary Artery DiseaseNCT02050399
Cardiovascular Oscillations in Coronary Patients With and Without Type 2 Diabetes
A study testing Isometric exercise in people with Coronary Artery Disease and Diabetes Mellitus, Type 2, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 45 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Diabetes Mellitus, Type 2
- What is being tested?
- Isometric exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2013to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de São Carlos
São Carlos, São Paulo, 13565-905
About this study
Official title: Cardiovascular Oscillations at Rest and During Isometric Exercise in Coronary Patients With and Without Type 2 Diabetes
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.
- Conditions
- Coronary Artery Disease, Diabetes Mellitus, Type 2
- Being tested
- Isometric exercise
- Keywords
- Isometric Exercise, Arterial Pressure, Autonomic Nervous System, Cardiovascular system, Posture
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Active comparator | 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. Receives: Other: Isometric exercise |
| Coronary disease with Type 2 Diabetes | Experimental | 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. Receives: Other: Isometric exercise |
| Coronary disease without Type 2 Diabetes | Experimental | 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. Receives: Other: Isometric exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startAug 2013
- Primary completionDec 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aparecida Maria Catai, Universidade Federal de Sao Carlos
- Investigators
- Aparecida Maria Catai, Principal investigator, Universidade Federal de Sao Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050399
- Sponsor's protocol ID
- 13287613.0.0000.5504
- Status last verified
- Jan 2014
- First submitted
- 16 Jan 2014
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
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 21180863Amaral 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 22801514Legramante 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 10100100Porta 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 20962207Krzeminski 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 21796411Millar 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Oscillations at Rest and During Isometric Exercise in Coronary Patients With and Without Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02050399
- Acronym / sponsor ID
- 13287613.0.0000.5504
- Conditions
- Coronary Artery Disease, Diabetes Mellitus, Type 2
- Keywords
- Isometric Exercise, Arterial Pressure, Autonomic Nervous System, Cardiovascular system, Posture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 30 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Active comparator | Other: Isometric exercise15 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. |
| Coronary disease with Type 2 Diabetes | Experimental | Other: Isometric exercise15 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. |
| Coronary disease without Type 2 Diabetes | Experimental | Other: Isometric exercise15 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. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isometric exerciseThe 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. | Other | Coronary disease with Type 2 Diabetes, Coronary disease without Type 2 Diabetes, Healthy subjects |
Primary outcome
Cardiovascular responses during isometric exercise
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)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- Background: PubMed 21180863Leite 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.
- Background: PubMed 22801514Amaral 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.
- Background: PubMed 10100100Legramante 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.
- Background: PubMed 20962207Porta 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.
- Background: PubMed 21796411Krzeminski 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.
- Background: PubMed 21165806Millar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aparecida Maria Catai principal investigator
Universidade Federal de Sao Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric exercise in people with Coronary Artery Disease and Diabetes Mellitus, Type 2, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular responses during isometric exercise (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02050399, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2018.