Coronary DiseaseNCT04977258
Different Hydration Strategies Associated With Aerobic Exercise In Coronary
A study testing Treadmill aerobic exercise without water intake, Treadmill aerobic exercise with water intake of a predetermined amount. and Treadmill aerobic exercise with water intake according to the desire to drink in people with Coronary 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 Disease
- What is being tested?
- Treadmill aerobic exercise without water intake, Treadmill aerobic exercise with water intake of a predetermined amount. and Treadmill aerobic exercise with water intake according to the desire to drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteBrazil
- Study dates
- 16 Aug 2021to 26 Feb 2022
- 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, 1 recruiting
- Recruiting
Luiz Carlos Masques Vanderlei
Presidente Prudente, São Paulo, 19060-900
Lorena Santos, BPT, 55019992359245, lorenaltafin@gmail.com
About this study
Official title: Effect of Different Hydration Strategies on Autonomic Acceleration During Recovery in Individuals With Coronary Artery Disease Undergoing 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 cardiac autonomic modulation with autonomic alterations known as the coronary arteries remain poorly understood. The aim of the study was to evaluate and compare whether different hydration strategies are able to promote acceleration of the recovery of autonomic modulation in individuals with coronary artery disease undergoing aerobic exercise. This study is a cross-over clinical trial, which will be developed based on an experimental procedure performed in four stages. A total of 31 individuals will be recruited in this study and will perform four standardized cardiovascular rehabilitation (CR) sessions. The participants will perform CR with mineral water intake in phase three and four. In phase three, the consumption will be done a quantity of water predetermined by the evaluator, based on the loss of body mass measured in the second session. In phase four, hydration will be carried out in an uncontrolled manner, according to the desire to drink water during the protocol.
- Conditions
- Coronary Disease
- Being tested
- Treadmill aerobic exercise without water intake, Treadmill aerobic exercise with water intake of a predetermined amount., Treadmill aerobic exercise with water intake according to the desire to drink
- Keywords
- Autonomic Nervous System, Fluid Therapy, Heart Rate, Exercise
- Medical subject headings
- Coronary 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 without water intakeOther
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 with water intake of a predetermined amount.Other
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 with water intake according to the desire to drinkOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Only treadmill aerobic exercise with 60 min recovery in supine position. Receives: Other: Treadmill aerobic exercise without water intake |
| Controlled hydration group | Experimental | Treadmill aerobic exercise with 60 min recovery in supine position, with mineral water predetermined intake. Receives: Other: Treadmill aerobic exercise with water intake of a predetermined amount. |
| Ad Libitum hydration group | Experimental | Treadmill aerobic exercise with 60 min recovery in supine position, with mineral water intake in an uncontrolled manner. Receives: Other: Treadmill aerobic exercise with water intake according to the desire to drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
Linear indices of heart rate variability in the time domain (SDNN, rMSSD).
Measured: up to six months
Heart rate variability
Linear indices of heart rate variability in the frequency domain (HF, LF, LF/HF)
Measured: up to six months
Heart rate variability
Geometric indices of heart rate variability (TINN, RRTRI, SD1, SD2, SD1/SD2)
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 Jul 2021
- Study start16 Aug 2021 (estimated)
- Primary completion26 Oct 2021 (estimated)
- Study completion26 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
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 Vanderlei, PhD, Study director, Universidade Estadual Paulista - UNESP - Campus de Presidente Prudente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977258
- Sponsor's protocol ID
- 34722320.0.0000.5402
- Status last verified
- Aug 2021
- First submitted
- 15 Jul 2021
- Last updated
- 11 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Hydration Strategies on Autonomic Acceleration During Recovery in Individuals With Coronary Artery Disease Undergoing Aerobic Exercise
- ClinicalTrials.gov ID
- NCT04977258
- Acronym / sponsor ID
- 34722320.0.0000.5402
- Conditions
- Coronary Disease
- Keywords
- Autonomic Nervous System, Fluid Therapy, Heart Rate, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- 16 Aug 2021 (estimated)
- Primary completion
- 26 Oct 2021 (estimated)
- Study completion
- 26 Feb 2022 (estimated)
- First posted
- 26 Jul 2021 (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 cardiac autonomic modulation with autonomic alterations known as the coronary arteries remain poorly understood. The aim of the study was to evaluate and compare whether different hydration strategies are able to promote acceleration of the recovery of autonomic modulation in individuals with coronary artery disease undergoing aerobic exercise. This study is a cross-over clinical trial, which will be developed based on an experimental procedure performed in four stages. A total of 31 individuals will be recruited in this study and will perform four standardized cardiovascular rehabilitation (CR) sessions. The participants will perform CR with mineral water intake in phase three and four. In phase three, the consumption will be done a quantity of water predetermined by the evaluator, based on the loss of body mass measured in the second session. In phase four, hydration will be carried out in an uncontrolled manner, according to the desire to drink water during the protocol.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Treadmill aerobic exercise without water intakeOnly treadmill aerobic exercise with 60 min recovery in supine position. |
| Controlled hydration group | Experimental | Other: Treadmill aerobic exercise with water intake of a predetermined amount.Treadmill aerobic exercise with 60 min recovery in supine position, with mineral water predetermined intake. |
| Ad Libitum hydration group | Experimental | Other: Treadmill aerobic exercise with water intake according to the desire to drinkTreadmill aerobic exercise with 60 min recovery in supine position, with mineral water intake in an uncontrolled manner. |
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 without water intakeThe 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 |
| Treadmill aerobic exercise with water intake of a predetermined amount.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. | Other | Controlled hydration group |
| Treadmill aerobic exercise with water intake according to the desire to drinkThe 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 | Ad Libitum hydration group |
Primary outcome
Heart rate variability
Time frame: up to six months
Linear indices of heart rate variability in the time domain (SDNN, rMSSD).
Heart rate variability
Time frame: up to six months
Linear indices of heart rate variability in the frequency domain (HF, LF, LF/HF)
Heart rate variability
Time frame: up to six months
Geometric indices of heart rate variability (TINN, RRTRI, SD1, SD2, SD1/SD2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Luiz Carlos 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 without water intake, Treadmill aerobic exercise with water intake of a predetermined amount. and Treadmill aerobic exercise with water intake according to the desire to drink in people with Coronary 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: status not confirmed, as of the sponsor's last update on 11 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lorena Santos, BPT (55019992359245, lorenaltafin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (time frame: up to six months). The study lists 3 primary outcomes in all. 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 11 Aug 2021.