Coronary Artery DiseaseNCT03198806
Water Intake Associated With Aerobic Exercise in Coronary
A study testing Treadmill aerobic exercise in supine position, Treadmill aerobic exercise and water intake in supine position and Treadmill aerobic exercise in orthostatic position in people with Coronary Artery Disease, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
Trial summary
The need to restore water losses resulting from physical activity has become established and diffused into international consensus for healthy individuals or high-performance athletes. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Treadmill aerobic exercise in supine position, Treadmill aerobic exercise and water intake in supine position and Treadmill aerobic exercise in orthostatic position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Aug 2018to 25 Jun 2019
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men with coronary heart disease ischemia, over 45 years
- At least three months of cardiovascular rehabilitation
Who cannot join
- smokers, alcoholics
- Uncontrolled metabolic disease (eg, uncontrolled diabetes and thyroid diseases)
- Abnormal hemodynamic responses during exercise such as disproportionate increase / fall of heart rate and / or blood pressure to low / high levels of load
- myocardial ischemia and / or severe ventricular arrhythmias during the exercise test
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Luiz Carlos Marques Vanderlei
Presidente Prudente, São Paulo, 19060-900
About this study
Official title: Influence of Hydration on Autonomic Behavior and Cardiorespiratory Parameters of Coronaropathy Submitted to Aerobic Exercise
The need to restore water losses resulting from physical activity has become established and diffused into international consensus for healthy individuals or high-performance athletes. However, the influence of fluid replacement when administered during and after exercise on cardiorespiratory parameters, cardiac autonomic modulation, and subjective perceptions of effort and pain of individuals with autonomic alterations known as the coronary arteries remain poorly understood. In this sense, this study intends to investigate the influence of hydration on cardiac autonomic modulation, cardiorespiratory parameters, subjective perception of exertion and pain of coronary arteries submitted to aerobic exercise in the model of a cardiovascular rehabilitation session. A total of 31 individuals will be recruited in this study and will perform four standardized cardiovascular rehabilitation sessions. Only in the second and the fourth session will the volunteers be instructed to ingest a quantity of water predetermined by the evaluator, based on the loss of body mass measured in the first and the third sessions. The outcomes (autonomic modulation, cardiorespiratory variables and perceptions) will be evaluated before, during and after exercise. The results of this study will enable professionals working with this population to implement awareness strategies on the importance of fluid intake in cardiovascular rehabilitation programs.
- Conditions
- Coronary Artery Disease
- Being tested
- Treadmill aerobic exercise in supine position, Treadmill aerobic exercise and water intake in supine position, Treadmill aerobic exercise in orthostatic position, Treadmill aerobic exercise and water intake in orthostatic position
- Keywords
- Autonomic Nervous System, Fluid Therapy, Heart Rate, Exercise
- Medical subject headings
- Coronary Artery Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill aerobic exercise in supine positionOther
The volunteers will be submitted to a cardiovascular rehabilitation session with 40 minutes of treadmill aerobic exercise followed by 60 minutes of recovery at the supine position.
Treadmill aerobic exercise and water intake in supine positionOther
The volunteers will be submitted to a cardiovascular rehabilitation session with 40 minutes of treadmill aerobic exercise and water intake followed by 60 minutes of recovery at the supine position.
Treadmill aerobic exercise in orthostatic positionOther
The volunteers will be submitted to a cardiovascular rehabilitation session with 40 minutes of treadmill aerobic exercise followed by 10 minutes of recovery at the orthostatic position.
Treadmill aerobic exercise and water intake in orthostatic positionOther
The volunteers will be submitted to a cardiovascular rehabilitation session with 40 minutes of treadmill aerobic exercise and water intake followed by 10 minutes of recovery at the orthostatic position.
| Study group | Role | What they receive |
|---|---|---|
| Control group in supine position | Active comparator | Intervention:
- Only treadmill aerobic exercise with 60 min recovery in supine position Receives: Other: Treadmill aerobic exercise in supine position |
| Hydration group in supine position | Experimental | Interventions:
* Treadmill aerobic exercise with 60 min recovery in supine position
* Water intake Receives: Other: Treadmill aerobic exercise and water intake in supine position |
| Control group in orthostatic position | Active comparator | Intervention:
- Only treadmill aerobic exercise with 10 min recovery in orthostatic position Receives: Other: Treadmill aerobic exercise in orthostatic position |
| Hydration group in orthostatic position | Experimental | Interventions:
* Treadmill aerobic exercise with 10 min recovery in orthostatic position
* Water intake Receives: Other: Treadmill aerobic exercise and water intake in orthostatic position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
Indices of heart rate variability
Measured: up to six months
Secondary outcomes (6)
Subjective Effort Perception
Borg Scale
Measured: up to six months
Subjective Pain Perception
Borg CR-10 Scale
Measured: up to six months
Cardiovascular parameter
Heart Rate
Measured: up to six months
Cardiovascular parameter
Blood Pressure
Measured: up to six months
Cardiorespiratory parameter
Respiratory frequency
Measured: up to six months
Cardiorespiratory parameter
Partial Oxygen Saturation
Measured: up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start25 Aug 2018
- Primary completion25 Dec 2018
- Study completion25 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luiz Carlos Marques Vanderlei, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- Luiz Carlos Marques Vanderlei, PhD, Study director, Universidade Estadual Paulista - UNESP - Campus de Presidente Prudente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198806
- Sponsor's protocol ID
- 54864716800005402
- Status last verified
- Jul 2020
- First submitted
- 19 Jun 2017
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Hydration on Autonomic Behavior and Cardiorespiratory Parameters of Coronaropathy Submitted to Aerobic Exercise
- ClinicalTrials.gov ID
- NCT03198806
- Acronym / sponsor ID
- 54864716800005402
- Conditions
- Coronary Artery Disease
- Keywords
- Autonomic Nervous System, Fluid Therapy, Heart Rate, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- 25 Aug 2018 (actual)
- Primary completion
- 25 Dec 2018 (actual)
- Study completion
- 25 Jun 2019 (actual)
- First posted
- 26 Jun 2017 (actual)
- 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.
The need to restore water losses resulting from physical activity has become established and diffused into international consensus for healthy individuals or high-performance athletes. However, the influence of fluid replacement when administered during and after exercise on cardiorespiratory parameters, cardiac autonomic modulation, and subjective perceptions of effort and pain of individuals with autonomic alterations known as the coronary arteries remain poorly understood. In this sense, this study intends to investigate the influence of hydration on cardiac autonomic modulation, cardiorespiratory parameters, subjective perception of exertion and pain of coronary arteries submitted to aerobic exercise in the model of a cardiovascular rehabilitation session. A total of 31 individuals will be recruited in this study and will perform four standardized cardiovascular rehabilitation sessions. Only in the second and the fourth session will the volunteers be instructed to ingest a quantity of water predetermined by the evaluator, based on the loss of body mass measured in the first and the third sessions. The outcomes (autonomic modulation, cardiorespiratory variables and perceptions) will be evaluated before, during and after exercise. The results of this study will enable professionals working with this population to implement awareness strategies on the importance of fluid intake in cardiovascular rehabilitation programs.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group in supine position | Active comparator | Other: Treadmill aerobic exercise in supine positionIntervention: - Only treadmill aerobic exercise with 60 min recovery in supine position |
| Hydration group in supine position | Experimental | Other: Treadmill aerobic exercise and water intake in supine positionInterventions: * Treadmill aerobic exercise with 60 min recovery in supine position * Water intake |
| Control group in orthostatic position | Active comparator | Other: Treadmill aerobic exercise in orthostatic positionIntervention: - Only treadmill aerobic exercise with 10 min recovery in orthostatic position |
| Hydration group in orthostatic position | Experimental | Other: Treadmill aerobic exercise and water intake in orthostatic positionInterventions: * Treadmill aerobic exercise with 10 min recovery in orthostatic position * Water intake |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men with coronary heart disease ischemia, over 45 years
- At least three months of cardiovascular rehabilitation
Key exclusion criteria (4 listed)
- smokers, alcoholics
- Uncontrolled metabolic disease (eg, uncontrolled diabetes and thyroid diseases)
- Abnormal hemodynamic responses during exercise such as disproportionate increase / fall of heart rate and / or blood pressure to low / high levels of load
- myocardial ischemia and / or severe ventricular arrhythmias during the exercise test
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 |
|---|---|---|
| Treadmill aerobic exercise in supine positionThe volunteers will be submitted to a cardiovascular rehabilitation session with 40 minutes of treadmill aerobic exercise followed by 60 minutes of recovery at the supine position. | Other | Control group in supine position |
| Treadmill aerobic exercise and water intake in supine positionThe volunteers will be submitted to a cardiovascular rehabilitation session with 40 minutes of treadmill aerobic exercise and water intake followed by 60 minutes of recovery at the supine position. | Other | Hydration group in supine position |
| Treadmill aerobic exercise in orthostatic positionThe volunteers will be submitted to a cardiovascular rehabilitation session with 40 minutes of treadmill aerobic exercise followed by 10 minutes of recovery at the orthostatic position. | Other | Control group in orthostatic position |
| Treadmill aerobic exercise and water intake in orthostatic positionThe volunteers will be submitted to a cardiovascular rehabilitation session with 40 minutes of treadmill aerobic exercise and water intake followed by 10 minutes of recovery at the orthostatic position. | Other | Hydration group in orthostatic position |
Primary outcome
Heart rate variability
Time frame: up to six months
Indices of heart rate variability
6 secondary outcomes
Subjective Effort Perception
Time frame: up to six months
Subjective Pain Perception
Time frame: up to six months
Cardiovascular parameter
Time frame: up to six months
Cardiovascular parameter
Time frame: up to six months
Cardiorespiratory parameter
Time frame: up to six months
Cardiorespiratory parameter
Time frame: up to six months
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 28 Jul 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Coronary Artery Disease
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
RecruitingPhase 4
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
Not yet recruiting
Effect of Propionic Acid Supplementation on Endothelial Function
Cardiovascular Diseases, Endothelial Dysfunction
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
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.
Luiz Carlos Marques Vanderlei, PhD study director
Universidade Estadual Paulista - UNESP - Campus de Presidente Prudente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill aerobic exercise in supine position, Treadmill aerobic exercise and water intake in supine position and Treadmill aerobic exercise in orthostatic position in people with Coronary Artery Disease, run by Universidade Estadual Paulista Júlio de Mesquita Filho 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 2 inclusion and 4 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 28 Jul 2020. 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?
Heart rate variability (time frame: up to six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2020.