Heart FailureNCT03506737
Exercise-based Cardiac Rehabilitation Program on Hospitalized Heart Failure Patients Submitted to Cardiac Transplantation
A study testing Conventional exercise protocol and Cycle ergometer exercise protocol in people with Heart Failure and Transplant; Failure, Heart, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Objective: To evaluate the effects of an early-based cardiac rehabilitation program on the functional capacity, inspiratory muscular strength and clinical outcomes in hospitalized heart failure patients before and after heart transplantation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Heart Failure, Transplant; Failure, Heart, Physical Activity
- What is being tested?
- Conventional exercise protocol and Cycle ergometer exercise protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2015to Dec 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart Failure diagnosis determined by clinical presentation and confirmed on echocardiography by clinicians, with a left ventricular ejection fraction (LVEF) < 40%
- New York Heart Association (NYHA) classes III and IV.
Who cannot join
- chronic lung disease confirmed by pulmonary function testing
- unstable angina pectoris and acute coronary syndromes
- dialysis
- neuromuscular and psychiatric conditions that interfere in exercise
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Caroline Bublitz Barbosa
São Paulo, 04024002
Caroline Barbosa
Isis Begot
About this study
Official title: Impact of an Exercise-based Cardiac Rehabilitation Program on Hospitalized Heart Failure Patients Submitted to Cardiac Transplantation: Clinical Trial
Objective: To evaluate the effects of an early-based cardiac rehabilitation program on the functional capacity, inspiratory muscular strength and clinical outcomes in hospitalized heart failure patients before and after heart transplantation. Method: 30 hospitalized heart failure patients awaiting cardiac transplantation will be selected and randomized in 2 groups: conventional group (n = 15) - conventional exercise protocol: breathing exercises and global active exercises of upper and lower limbs in the sitting position; and Intervention group (n = 15) - cycle ergometer exercise protocol: each session consists of cycling on a stationary bicycle in the seated position for 20 minutes. In both groups, the exercise protocols will be applied twice a day until the hospital discharge, always supervised by a physiotherapist and a doctor. The evaluation procedures in all patients of the research will be: functional capacity measured by the 6 minute walk test and inspiratory muscle strength measured by manovacuometry. Evaluations will be repeated in 3 distinct moments: after 24h of hospital admission and/or clinical stabilization; before transplantation and after transplantation in hospital discharge.
- Conditions
- Heart Failure, Transplant; Failure, Heart, Physical Activity
- Being tested
- Conventional exercise protocol, Cycle ergometer exercise protocol
- 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.
Conventional exercise protocolOther
Breathing exercises and global active exercises of the upper and lower limbs while in the upright seated position
Cycle ergometer exercise protocolOther
Stationary cycle ergometer exercise while in the upright seated position for 20 minutes. The protocol will be performed intermittently with 5 periods; each period consists of 3 minutes of cycling followed by 1-minute of rest.
| Study group | Role | What they receive |
|---|---|---|
| Conventional exercise protocol | Experimental | Conventional global exercise Receives: Other: Conventional exercise protocol |
| Cycle ergometer exercise protocol | Experimental | Stationary cycle ergometer exercise Receives: Other: Cycle ergometer exercise protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-minute walk test to measure functional capacity change
According to the baseline distance walked, we will evaluate the improvement in functional capacity after the period of the rehabilitation programs
Measured: After 24 hours of hospital admission or clinical stabilization; before transplantation (after 4 weeks of rehabilitation program) and in hospital discharge (after 4 weeks of transplantation).
Respiratory muscle strength
By manovacuometry, assessing the change in inspiratory muscle pressure and expiratory muscle pressure
Measured: After 24 hours of hospital admission or clinical stabilization; before transplantation (after 4 weeks of rehabilitation program) and in hospital discharge (after 4 weeks of transplantation)
Secondary outcomes (3)
Invasive mechanical ventilation
Duration of invasive mechanical ventilation will be recorded after cardiac transplantation.
Measured: First day after transplantation.
Duration of intensive care unit stay
Duration of stay in intensive care unit (in days) after transplantation will be recorded.
Measured: In hospital discharge (after 4 weeks of transplantation).
Hospitalization stay
Duration of stay in the hospital (in days) will be recorded.
Measured: In hospital discharge (after 4 weeks of transplantation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study startJan 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline Bublitz Barbosa, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506737
- Sponsor's protocol ID
- 74619617.3.0000.5505
- Status last verified
- Apr 2018
- First submitted
- 4 Apr 2018
- Last updated
- 24 Apr 2018
- 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 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Exercise-based Cardiac Rehabilitation Program on Hospitalized Heart Failure Patients Submitted to Cardiac Transplantation: Clinical Trial
- ClinicalTrials.gov ID
- NCT03506737
- Acronym / sponsor ID
- 74619617.3.0000.5505
- Conditions
- Heart Failure, Transplant; Failure, Heart, Physical Activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 24 Apr 2018 (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.
Objective: To evaluate the effects of an early-based cardiac rehabilitation program on the functional capacity, inspiratory muscular strength and clinical outcomes in hospitalized heart failure patients before and after heart transplantation. Method: 30 hospitalized heart failure patients awaiting cardiac transplantation will be selected and randomized in 2 groups: conventional group (n = 15) - conventional exercise protocol: breathing exercises and global active exercises of upper and lower limbs in the sitting position; and Intervention group (n = 15) - cycle ergometer exercise protocol: each session consists of cycling on a stationary bicycle in the seated position for 20 minutes. In both groups, the exercise protocols will be applied twice a day until the hospital discharge, always supervised by a physiotherapist and a doctor. The evaluation procedures in all patients of the research will be: functional capacity measured by the 6 minute walk test and inspiratory muscle strength measured by manovacuometry. Evaluations will be repeated in 3 distinct moments: after 24h of hospital admission and/or clinical stabilization; before transplantation and after transplantation in hospital discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional exercise protocol | Experimental | Other: Conventional exercise protocolConventional global exercise |
| Cycle ergometer exercise protocol | Experimental | Other: Cycle ergometer exercise protocolStationary cycle ergometer exercise |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Heart Failure diagnosis determined by clinical presentation and confirmed on echocardiography by clinicians, with a left ventricular ejection fraction (LVEF) < 40%
- New York Heart Association (NYHA) classes III and IV.
Key exclusion criteria (4 listed)
- chronic lung disease confirmed by pulmonary function testing
- unstable angina pectoris and acute coronary syndromes
- dialysis
- neuromuscular and psychiatric conditions that interfere in exercise
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 |
|---|---|---|
| Conventional exercise protocolBreathing exercises and global active exercises of the upper and lower limbs while in the upright seated position | Other | Conventional exercise protocol |
| Cycle ergometer exercise protocolStationary cycle ergometer exercise while in the upright seated position for 20 minutes. The protocol will be performed intermittently with 5 periods; each period consists of 3 minutes of cycling followed by 1-minute of rest. | Other | Cycle ergometer exercise protocol |
Primary outcome
Six-minute walk test to measure functional capacity change
Time frame: After 24 hours of hospital admission or clinical stabilization; before transplantation (after 4 weeks of rehabilitation program) and in hospital discharge (after 4 weeks of transplantation).
According to the baseline distance walked, we will evaluate the improvement in functional capacity after the period of the rehabilitation programs
Respiratory muscle strength
Time frame: After 24 hours of hospital admission or clinical stabilization; before transplantation (after 4 weeks of rehabilitation program) and in hospital discharge (after 4 weeks of transplantation)
By manovacuometry, assessing the change in inspiratory muscle pressure and expiratory muscle pressure
3 secondary outcomes
Invasive mechanical ventilation
Time frame: First day after transplantation.
Duration of intensive care unit stay
Time frame: In hospital discharge (after 4 weeks of transplantation).
Hospitalization stay
Time frame: In hospital discharge (after 4 weeks of transplantation).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional exercise protocol and Cycle ergometer exercise protocol in people with Heart Failure and Transplant; Failure, Heart, run by Federal University of São Paulo 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 24 Apr 2018. 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 Caroline Barbosa (5511 953578342, carolinebublitz@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-minute walk test to measure functional capacity change (time frame: After 24 hours of hospital admission or clinical stabilization; before transplantation (after 4 weeks of rehabilitation program) and in hospital discharge (after 4 weeks of transplantation).). The study lists 2 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 24 Apr 2018.