Arteriosclerosis, CoronaryEarly Phase 1NCT02198872
Aquatic and Land Aerobic Training, Cardiorespiratory and Metabolic Variables in Cardiorespiratory Diseases
A Early Phase 1 study testing Exercise, Aerobic (Water based) and Land Group in people with Arteriosclerosis, Coronary, run by Universidade Metodista de Piracicaba at 1 site in Brazil.
Trial summary
In the pathophysiological process of coronary artery disease (CAD), are present, autonomic dysfunction and reduced functional capacity. Studies showed that physical training (PT) is critical in the treatment of CAD by promoting beneficial effects. 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) and Land Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2014to Feb 2018
- Phase
- Early Phase 1
- 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.
Brazil1 site
Universidade Metodista de Piracicaba
Piracicaba, São Paulo, 55
Elie, Fiogbé, felie1883@yahoo.fr
Elie Fiogbé, Ms
About this study
Official title: Effects of Aquatic and Land Aerobic Training on Body Composition and Cardiorespiratory and Metabolic Variables in Patients With Cardiorespiratory Diseases
In the pathophysiological process of coronary artery disease (CAD), are present, autonomic dysfunction and reduced functional capacity. Studies showed that physical training (PT) is critical in the treatment of CAD by promoting beneficial effects. Although water based exercises program have been documented in patients with various cardiovascular diseases, the most of studies among patients with CAD used land based exercises programs. OBJECTIVE: To evaluate and compare the effects of aerobic water (WPT) and land (LPT) based PT on autonomic modulation of heart rate (HR), body composition and cardiorespiratory and metabolic variables in patients with CAD. METHODS : 40 men between 50 and 70 years old with CAD diagnosed by coronary angiography showing obstruction greater than 50% and underwent angioplasty will be evaluated in 4 stages; 1) immediately after angioplasty, clinical assessment, body composition analysis and recording of HR and NN intervals during rest. 2) The components of step 1) will be repeated after three month, adding the record of HR and NN before, during and after the Valsalva maneuver, spirometry and cardiopulmonary exercise testing. 3) Volunteers will be randomly divided into two groups, WPT and LPT for 48 sessions. 4) The components of step 2) are repeated after each period of 12 sessions. Thus, it is expected that WPT promote beneficial physiological adaptations in CAD patients with obstruction greater than 50%.
Read the detailed description
- Immediately after angioplasty, the volunteers will be subject to an assessment (Assessment 0), which will consist of:
- 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.
- Analysis of body composition by bioelectrical impedance analysis.
- Registration of HR and NN intervals (NN) during rest, in the supine and sitting positions.
- biochemical blood tests: complete blood count, blood glucose, total cholesterol, LDL and HDL cholesterol, triglycerides, and C-reactive protein ultrasensitive.
- Recording of HR and NN during rest in the supine position, sitting, standing and during respiratory sinus arrhythmia maneuver.
- Three months after the "Assessment 0", the volunteers will be subject to an assessment (initial Assessment) prior to physical training program. Will be repeated all assessments performed in the "Assessment 0" plus the record of HR and R-Ri before, during and after the Valsalva maneuver, spirometry 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.
- After this assessment, the volunteers will be randomly assigned to one of two groups, aerobic water (WPT) or land (LPT) based physical training.
- Components of "Initial Assessment" will be repeated at the end of each month of physical training (Revaluation 1, 2 and 3) and the end (Final Assessment).
- Conditions
- Arteriosclerosis, Coronary
- Being tested
- Exercise, Aerobic (Water based), Land Group
- Keywords
- Autonomic Nervous System, Body composition, Oxygen Uptake,, Water Based Physical Training, Land 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 will be submitted to an aerobic water based physical training
Land GroupOther
Patients of this group perform physical training on bicycle.
| Study group | Role | What they receive |
|---|---|---|
| Exercise, Aerobic (Water based) | Experimental | Patients of this group will be submitted to an aerobic water based physical training Receives: Other: Exercise, Aerobic (Water based) |
| Land Group | Active comparator | Patients of this group perform physical training on bicycle. Receives: Other: Land Group |
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: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionJul 2015 (estimated)
- Study completionFeb 2018 (estimated)
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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
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
- NCT02198872
- Sponsor's protocol ID
- 03/13
- Other IDs
- 190729/2011-2
- Status last verified
- Jul 2014
- First submitted
- 15 Jul 2014
- Last updated
- 24 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aquatic and Land Aerobic Training on Body Composition and Cardiorespiratory and Metabolic Variables in Patients With Cardiorespiratory Diseases
- ClinicalTrials.gov ID
- NCT02198872
- Acronym / sponsor ID
- 03/13
- Conditions
- Arteriosclerosis, Coronary
- Keywords
- Autonomic Nervous System, Body composition, Oxygen Uptake,, Water Based Physical Training, Land Based Physical Training.
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidade Metodista de PiracicabaUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 24 Jul 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.
In the pathophysiological process of coronary artery disease (CAD), are present, autonomic dysfunction and reduced functional capacity. Studies showed that physical training (PT) is critical in the treatment of CAD by promoting beneficial effects. Although water based exercises program have been documented in patients with various cardiovascular diseases, the most of studies among patients with CAD used land based exercises programs. OBJECTIVE: To evaluate and compare the effects of aerobic water (WPT) and land (LPT) based PT on autonomic modulation of heart rate (HR), body composition and cardiorespiratory and metabolic variables in patients with CAD. METHODS : 40 men between 50 and 70 years old with CAD diagnosed by coronary angiography showing obstruction greater than 50% and underwent angioplasty will be evaluated in 4 stages; 1) immediately after angioplasty, clinical assessment, body composition analysis and recording of HR and NN intervals during rest. 2) The components of step 1) will be repeated after three month, adding the record of HR and NN before, during and after the Valsalva maneuver, spirometry and cardiopulmonary exercise testing. 3) Volunteers will be randomly divided into two groups, WPT and LPT for 48 sessions. 4) The components of step 2) are repeated after each period of 12 sessions. Thus, it is expected that WPT promote beneficial physiological adaptations in CAD patients with obstruction greater than 50%.
Detailed description
- Immediately after angioplasty, the volunteers will be subject to an assessment (Assessment 0), which will consist of:
- 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.
- Analysis of body composition by bioelectrical impedance analysis.
- Registration of HR and NN intervals (NN) during rest, in the supine and sitting positions.
- biochemical blood tests: complete blood count, blood glucose, total cholesterol, LDL and HDL cholesterol, triglycerides, and C-reactive protein ultrasensitive.
- Recording of HR and NN during rest in the supine position, sitting, standing and during respiratory sinus arrhythmia maneuver.
- Three months after the "Assessment 0", the volunteers will be subject to an assessment (initial Assessment) prior to physical training program. Will be repeated all assessments performed in the "Assessment 0" plus the record of HR and R-Ri before, during and after the Valsalva maneuver, spirometry 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.
- After this assessment, the volunteers will be randomly assigned to one of two groups, aerobic water (WPT) or land (LPT) based physical training.
- Components of "Initial Assessment" will be repeated at the end of each month of physical training (Revaluation 1, 2 and 3) and the end (Final Assessment).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise, Aerobic (Water based) | Experimental | Other: Exercise, Aerobic (Water based)Patients of this group will be submitted to an aerobic water based physical training |
| Land Group | Active comparator | Other: Land GroupPatients of this group perform physical training on bicycle. |
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 will be submitted to an aerobic water based physical training | Other | Exercise, Aerobic (Water based) |
| Land GroupPatients of this group perform physical training on bicycle. | Other | Land Group |
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: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 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 Early Phase 1 study testing Exercise, Aerobic (Water based) and Land Group 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: status not confirmed, as of the sponsor's last update on 24 Jul 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Elie Fiogbé, Ms (+5519983616077, felie1883@yahoo.fr), or a site near the patient. 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 24 Jul 2014.