Arteriosclerosis, CoronaryNCT02211573
Aquatic Aerobic Training, Cardiorespiratory and Metabolic Variables in Coronary Artery Disease
A study testing Exercise, Aerobic (Water based) in people with Arteriosclerosis, Coronary, run by Universidade Metodista de Piracicaba at 1 site in Brazil.
Trial summary
Although approaches to reduce cardiovascular disease, coronary artery disease (CAD) remains the leading cause of mortality in the industrialized world. In order to reduce the deleterious effects of the atherosclerotic process, proposals for non-pharmacological treatment have been used, such as cardiac rehabilitation… Read more about this study
- Who is it for?
- Ages 50 to 70 years, men only
- Conditions the study is for
- Arteriosclerosis, Coronary
- What is being tested?
- Exercise, Aerobic (Water based)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteBrazil
- Study dates
- May 2013to Mar 2014
- 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 50 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis by angiography
- sedentaries
- family story of cardiac disease
- obesity
Who cannot join
- frequent arrhythmias at rest
- triggered by physical effort
- unstable angina
- chronic obstructive pulmonary disease
- insulin-dependent diabet
- renal failure
Show all 12Show fewer
- sequel of stroke
- uncontrolled hypothyroidism
- water phobia
- skin infections, allergic reactions to chlorine,
- urinary incontinence and
- musculoskeletal and neuromuscular disorders precluding physical tests and training sessions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Aquatic Aerobic Training on Body Composition and Cardiorespiratory and Metabolic Variables in Patients With Coronary Artery Disease
Although approaches to reduce cardiovascular disease, coronary artery disease (CAD) remains the leading cause of mortality in the industrialized world. In order to reduce the deleterious effects of the atherosclerotic process, proposals for non-pharmacological treatment have been used, such as cardiac rehabilitation programs, with emphasis on exercise -based therapy. Traditionally aerobic exercises like biking, walking and jogging are conducted, however, alternative ways such as aquatic exercise training have been proposed, however, the cardiorespiratory adaptations in this population are not well documented in the literature. Thus, the aim of this study was to evaluate the effects of aquatic aerobic training (AAT) on body composition, autonomic modulation of heart rate (HR) and cardiorespiratory and metabolic variables in patients with CAD. This was a longitudinal clinical trial with a sample allocated for convenience, in which twenty-one patients were male, with a diagnosis of CAD, which were divided into control group (CG were studied, n=8), who was only assessed, and training group (TG, n=13). All patients underwent assessment of body composition, heart rate variability (HRV) at rest in the supine posture, and cardiopulmonary exercise testing (CPET), performed before and after the AAT program. The training protocol consisted of three sessions per week on alternate days for 16 weeks, totaling 48 sessions, which had lasted approximately one hour. The exercise intensity was prescribed between 80 and 110% of the first ventilatory threshold (VT1) obtained in CPET. Given that these parameters represent risk markers for cardiovascular events in the population studied, the results suggest that the AAT proposed in this study may be an important therapeutic strategy to be incorporated into cardiac rehabilitation programs.
Read the detailed description
- Personal Data recording:
- History: personal data, lifestyle and food, family history, current and previous history of disease.
- Physical examination: cardiac and lung auscultation,measurement of heart rate (HR), blood pressure (BP), body weight and height.
- Assessments: All experimental procedures were performed in the morning in order to minimize the influence of circadian cycle. The temperature of the experimental room was maintained between 22 ° C and 24 ° C with relative humidity between 40% and 60%. Patients were familiarized with the experimental protocol, and instructed not to ingest stimulant drinks such as coffee, tea and soft drinks, do not drink alcohol, do not perform strenuous exercise (48 hours before surgery), and to perform a light meal at least four hours before the collections. Aiming to verify if the baseline conditions were suitable for the beginning of the experimental procedures, the patients remained 15 minutes of rest in the supine position, and recorded blood pressure (BP) and HR. After this, were performed:
- Analysis of body composition by bioelectrical impedance analysis.
- Registration of HR and NN intervals (NN) during rest, in the supine and sitting positions.
- Recording of HR and NN during rest in the supine position, sitting, standing and during respiratory sinus arrhythmia maneuver.
- Spirometric test and
- Cardiopulmonary exercise test (CPET). This is a submaximal CPET performed on a treadmill, in order to verify and identify possible changes in hemodynamic, electrocardiographic induced to physical exertion, their aerobic functional capacity as well as to prescribe physical training protocol.
- Training: After this assessment the volunteers were trained by a aerobic water based physical training program for 4 weeks.
- Second assessment:
Components of the first assessment have been repeated at the end of each month of physical training.
- Conditions
- Arteriosclerosis, Coronary
- Being tested
- Exercise, Aerobic (Water based)
- Keywords
- Autonomic Nervous System, Body composition, Oxygen Uptake,, Water Based Physical Training.
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise, Aerobic (Water based)Other
Patients of this group were submitted to an aerobic water based physical training
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Patients of this group don't performed physical training |
| Exercise, Aerobic (Water based) | Experimental | Patients of this group were submitted to an aerobic water based physical training Receives: Other: Exercise, Aerobic (Water based) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in autonomic system modulation
Change in autonomic system modulation in assess by comparing the heart rate variability at baseline and after a 16 weeks of aerobic water and land based physical training.
Measured: baseline and 16 weeks
Secondary outcomes (1)
Change in body composition
Change in body composition is assess by comparing the body composition at baseline and after a 16 weeks of aerobic water and land based physical training.
Measured: baseline and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startMay 2013
- Primary completionOct 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriosclerosis, CoronaryStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Metodista de Piracicaba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elie Fiogbé, Universidade Metodista de Piracicaba
- Investigators
- Elie Fiogbé, Ms, Principal investigator, Universidade Metodista de Piracicaba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211573
- Sponsor's protocol ID
- 03/14
- Status last verified
- Aug 2014
- First submitted
- 5 Aug 2014
- Last updated
- 7 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aquatic Aerobic Training on Body Composition and Cardiorespiratory and Metabolic Variables in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT02211573
- Acronym / sponsor ID
- 03/14
- Conditions
- Arteriosclerosis, Coronary
- Keywords
- Autonomic Nervous System, Body composition, Oxygen Uptake,, Water Based Physical Training.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Universidade Metodista de PiracicabaUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 7 Aug 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.
Although approaches to reduce cardiovascular disease, coronary artery disease (CAD) remains the leading cause of mortality in the industrialized world. In order to reduce the deleterious effects of the atherosclerotic process, proposals for non-pharmacological treatment have been used, such as cardiac rehabilitation programs, with emphasis on exercise -based therapy. Traditionally aerobic exercises like biking, walking and jogging are conducted, however, alternative ways such as aquatic exercise training have been proposed, however, the cardiorespiratory adaptations in this population are not well documented in the literature. Thus, the aim of this study was to evaluate the effects of aquatic aerobic training (AAT) on body composition, autonomic modulation of heart rate (HR) and cardiorespiratory and metabolic variables in patients with CAD. This was a longitudinal clinical trial with a sample allocated for convenience, in which twenty-one patients were male, with a diagnosis of CAD, which were divided into control group (CG were studied, n=8), who was only assessed, and training group (TG, n=13). All patients underwent assessment of body composition, heart rate variability (HRV) at rest in the supine posture, and cardiopulmonary exercise testing (CPET), performed before and after the AAT program. The training protocol consisted of three sessions per week on alternate days for 16 weeks, totaling 48 sessions, which had lasted approximately one hour. The exercise intensity was prescribed between 80 and 110% of the first ventilatory threshold (VT1) obtained in CPET. Given that these parameters represent risk markers for cardiovascular events in the population studied, the results suggest that the AAT proposed in this study may be an important therapeutic strategy to be incorporated into cardiac rehabilitation programs.
Detailed description
- Personal Data recording:
- History: personal data, lifestyle and food, family history, current and previous history of disease.
- Physical examination: cardiac and lung auscultation,measurement of heart rate (HR), blood pressure (BP), body weight and height.
- Assessments: All experimental procedures were performed in the morning in order to minimize the influence of circadian cycle. The temperature of the experimental room was maintained between 22 ° C and 24 ° C with relative humidity between 40% and 60%. Patients were familiarized with the experimental protocol, and instructed not to ingest stimulant drinks such as coffee, tea and soft drinks, do not drink alcohol, do not perform strenuous exercise (48 hours before surgery), and to perform a light meal at least four hours before the collections. Aiming to verify if the baseline conditions were suitable for the beginning of the experimental procedures, the patients remained 15 minutes of rest in the supine position, and recorded blood pressure (BP) and HR. After this, were performed:
- Analysis of body composition by bioelectrical impedance analysis.
- Registration of HR and NN intervals (NN) during rest, in the supine and sitting positions.
- Recording of HR and NN during rest in the supine position, sitting, standing and during respiratory sinus arrhythmia maneuver.
- Spirometric test and
- Cardiopulmonary exercise test (CPET). This is a submaximal CPET performed on a treadmill, in order to verify and identify possible changes in hemodynamic, electrocardiographic induced to physical exertion, their aerobic functional capacity as well as to prescribe physical training protocol.
- Training: After this assessment the volunteers were trained by a aerobic water based physical training program for 4 weeks.
- Second assessment:
Components of the first assessment have been repeated at the end of each month of physical training.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patients of this group don't performed physical training |
| Exercise, Aerobic (Water based) | Experimental | Other: Exercise, Aerobic (Water based)Patients of this group were submitted to an aerobic water based physical training |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis by angiography
- sedentaries
- family story of cardiac disease
- obesity
Key exclusion criteria (12 listed)
- frequent arrhythmias at rest
- triggered by physical effort
- unstable angina
- chronic obstructive pulmonary disease
- insulin-dependent diabet
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 |
|---|---|---|
| Exercise, Aerobic (Water based)Patients of this group were submitted to an aerobic water based physical training | Other | Exercise, Aerobic (Water based) |
Primary outcome
Change in autonomic system modulation
Time frame: baseline and 16 weeks
Change in autonomic system modulation in assess by comparing the heart rate variability at baseline and after a 16 weeks of aerobic water and land based physical training.
1 secondary outcome
Change in body composition
Time frame: baseline and 16 weeks
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 7 Aug 2014.
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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.
Elie Fiogbé, Ms principal investigator
Universidade Metodista de Piracicaba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Aerobic (Water based) in people with Arteriosclerosis, Coronary, run by Universidade Metodista de Piracicaba 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 4 inclusion and 12 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 7 Aug 2014. 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?
Change in autonomic system modulation (time frame: baseline and 16 weeks). 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 7 Aug 2014.