Congestive Heart FailurePhase 2/3CHFNCT00989248
Comparative Study of Cardiopulmonary Exercise Test Land Versus Water
A Phase 2/3 study testing Aerobic and anaerobic capacity use aquatic exercises in people with Congestive Heart Failure, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
At the neck level immersion, the water pressure causes significant displacement of blood from the lower limbs to the Intrathoracic circulation, triggering adaptive physiological responses due to the increase in central blood volume and consequent cardiovascular burdens. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Aerobic and anaerobic capacity use aquatic exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2011to Jul 2012
- Phase
- Phase 2/3
- 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 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Patientes, 55 - 75 year, with Congestive Heart Failure (CHF)Functional class I - II and III according to the New York Heart Association (NYHA) and Injection Fracion 32% to 38%
Exclusion Criteria: Any peripheral artery disease, diabetes, pulmonary disease, hypertension (blood pressure >160/90) or significant cardiovascular morbidity.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Clinical Hospital, School of Medicine, University of Sao Paulo
São Paulo, São Paulo, 04116-040
Eduardo Massad, Doctor, 55 11 30617097, edmassad@usp.br
Fabiola Jomar, MSc, 55 11 55490111 ext. 266, fabjomar@uol.com.br
About this study
Official title: Comparative Study of Cardiopulmonary Exercise Test on Land and Underwater in Patients With Congestive Heart Failure
At the neck level immersion, the water pressure causes significant displacement of blood from the lower limbs to the Intrathoracic circulation, triggering adaptive physiological responses due to the increase in central blood volume and consequent cardiovascular burdens. Immersion in warm water breaks the homeostasis, stimulates regulation mechanisms and responses of organs and systems beneficial to healthy and heart failure individuals. In literature there are a growing number of studies demonstrating the efficacy of exercises performed in the water.
Read the detailed description
This study is about to compare the responses of one effort in two different environment. A group of 90 men, age between 55 to 75 years old recruited after a medical consultation, with the diagnostic of Congestive Heart Failure (CHF), under treatment at the Institute of Medicine and Rehabilitation and Institute Dante Pazzanesi, considered clinically stable (no cardiac symptoms or changes in medication for at least 30 days) and Funcional Class I, II, III according to NYHA.
Experimental Design: Patients will perform an test, first on land, and in a week time in a underwater treadmill. The data will be collected in four distinct moments: 1- anaerobic threshold (AT), 2- respiratory compensation point (RCP), 3- maximal effort (ME) and recovery (R). We will compare the following variables: test total time; perceived exertion scale (Borg); Heart rate (HR); Oxygen consumption (VO2); Carbon Dioxide production (VCO2); Oxygen pulse (VO2/FC); the ventilatory efficiency (VE/VO2) and (VE/VCO2); Respiratory quotient (VCO2/VO2); Systolic and Diastolic blood pressure; electrocardiographic changes, compatible with ischemia or arrhythmia.
- Conditions
- Congestive Heart Failure
- Being tested
- Aerobic and anaerobic capacity use aquatic exercises
- Keywords
- Ergospirometry, Cardiopulmonary Exercise Test, Exercises, Immersion
- Medical subject headings
- Heart Failure, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic and anaerobic capacity use aquatic exercisesOther
Also called Aerobic and anaerobic capacities
Improve aerobic capacity use aquatic exercises in patients with Congestive Heart Failure
| Study group | Role | What they receive |
|---|---|---|
| comparation VE/VO2 and VE/VCO2 | Experimental | Not described Receives: Other: Aerobic and anaerobic capacity use aquatic exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
To appraisal the cardiopulmonar activities during the effort on land and in immersion
Measured: one year
Secondary outcomes (1)
To develop an especific water protocol for reabilitations of patients with Congestive Heart Failure (CHF). The authors expect a beneficial adaptive response to the exercise in water comparing exercise on land.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2009 (estimated)
- Study startApr 2011
- Primary completionDec 2011 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Dante Pazzanese de Cardiologia
- Investigators
- Mauricio K Garcia, PhD, Study chair, Shool of Medicine, University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989248
- Sponsor's protocol ID
- CAPPESq 0532/08
- Acronym
- CHF
- Status last verified
- Apr 2011
- First submitted
- 2 Oct 2009
- Last updated
- 28 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Garcia MK, Rizzo L, Yazbek-Junior P, Yutiyama D, Silva FJD, Matheus D, Mastrocolla LE, Massad E. Cardiorespiratory performance of coronary artery disease patients on land versus underwater treadmill tests: a comparative study. Clinics (Sao Paulo). 2017 Nov;72(11):667-674. doi: 10.6061/clinics/2017(11)04.
PubMed 29236912
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Cardiopulmonary Exercise Test on Land and Underwater in Patients With Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT00989248
- Acronym / sponsor ID
- CHF / CAPPESq 0532/08
- Conditions
- Congestive Heart Failure
- Keywords
- Ergospirometry, Cardiopulmonary Exercise Test, Exercises, Immersion
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Instituto Dante Pazzanese de Cardiologia
- Study start
- Apr 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 5 Oct 2009 (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.
At the neck level immersion, the water pressure causes significant displacement of blood from the lower limbs to the Intrathoracic circulation, triggering adaptive physiological responses due to the increase in central blood volume and consequent cardiovascular burdens. Immersion in warm water breaks the homeostasis, stimulates regulation mechanisms and responses of organs and systems beneficial to healthy and heart failure individuals. In literature there are a growing number of studies demonstrating the efficacy of exercises performed in the water.
Detailed description
This study is about to compare the responses of one effort in two different environment. A group of 90 men, age between 55 to 75 years old recruited after a medical consultation, with the diagnostic of Congestive Heart Failure (CHF), under treatment at the Institute of Medicine and Rehabilitation and Institute Dante Pazzanesi, considered clinically stable (no cardiac symptoms or changes in medication for at least 30 days) and Funcional Class I, II, III according to NYHA.
Experimental Design: Patients will perform an test, first on land, and in a week time in a underwater treadmill. The data will be collected in four distinct moments: 1- anaerobic threshold (AT), 2- respiratory compensation point (RCP), 3- maximal effort (ME) and recovery (R). We will compare the following variables: test total time; perceived exertion scale (Borg); Heart rate (HR); Oxygen consumption (VO2); Carbon Dioxide production (VCO2); Oxygen pulse (VO2/FC); the ventilatory efficiency (VE/VO2) and (VE/VCO2); Respiratory quotient (VCO2/VO2); Systolic and Diastolic blood pressure; electrocardiographic changes, compatible with ischemia or arrhythmia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| comparation VE/VO2 and VE/VCO2 | Experimental | Other: Aerobic and anaerobic capacity use aquatic exercises |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Aerobic and anaerobic capacity use aquatic exercisesAlso: Aerobic and anaerobic capacitiesImprove aerobic capacity use aquatic exercises in patients with Congestive Heart Failure | Other | comparation VE/VO2 and VE/VCO2 |
Primary outcome
To appraisal the cardiopulmonar activities during the effort on land and in immersion
Time frame: one year
1 secondary outcome
To develop an especific water protocol for reabilitations of patients with Congestive Heart Failure (CHF). The authors expect a beneficial adaptive response to the exercise in water comparing exercise on land.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2011.
- Derived from this study: PubMed 29236912Garcia MK, Rizzo L, Yazbek-Junior P, Yutiyama D, Silva FJD, Matheus D, Mastrocolla LE, Massad E. Cardiorespiratory performance of coronary artery disease patients on land versus underwater treadmill tests: a comparative study. Clinics (Sao Paulo). 2017 Nov;72(11):667-674. doi: 10.6061/clinics/2017(11)04.
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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.
Mauricio K Garcia, PhD study chair
Shool of Medicine, University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Aerobic and anaerobic capacity use aquatic exercises in people with Congestive Heart Failure, run by University of Sao Paulo General Hospital 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?
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 28 Apr 2011. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Mauricio K Garcia, Phd (55 11 9903-7185, mauriciokg@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To appraisal the cardiopulmonar activities during the effort on land and in immersion (time frame: one year). 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 NCT00989248, which also lists 1 linked publication.
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 Apr 2011.