Decompensated Heart FailureERICNCT04733365
Exercise in Patients Admitted With Recently Decompensated Heart Failure
A study testing ERIC protocol in people with Decompensated Heart Failure and Functional Cardiac Disorder, run by Centro Hospitalar do Porto at 3 sites in Portugal.
Trial summary
An aerobic physical exercise protocol will be applied to patients admitted in ward due to decompensated heart failure, in order to validate the efficacy and safety of physical exercise in this phase of clinical stabilization, through the said training protocol - ERIC program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decompensated Heart Failure, Functional Cardiac Disorder
- What is being tested?
- ERIC protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 3 sitesPortugal
- Study dates
- 2 Dec 2017to 31 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission diagnosis of Decompensated heart failure
- More than 18 years old
- Capacity to provide informed consent
Who cannot join
- Osteoarticular pathology that impedes the performance of the exercise;
- Existence of inotropic infusions;
- Dysrhythmia or precordial pain in the last 24 hours,
- Acute pulmonary edema in the last 12 hours,
- SBP greater than 180mmHg or less than 80 mmHg (except in cases where this is the baseline value for the patient),
- Need for oxygen at a rate greater than 3 l / min,
- Glycemic decompensation in the last 12 hours,
Trial locations and contacts
3 sites in 1 country.
Portugal3 sites
Hospital Infante D Pedro
Aveiro
Hospital Pulido Valente
Lisbon
Centro Hospitalar de Vila Nova de Gaia
Vila Nova de Gaia
About this study
Official title: Nursing Rehabilitation on Patients Admitted by Recently Decompensated Heart Failure (ERIC Program) - Impact of Exercise
An aerobic physical exercise protocol will be applied to patients admitted in ward due to decompensated heart failure, in order to validate the efficacy and safety of physical exercise in this phase of clinical stabilization, through the said training protocol - ERIC program.
Read the detailed description
With the objective of validating the efficacy and safety of physical exercise as a therapeutic resource in patients admitted for decompensated heart failure; will be applied, by rehabilitation nurses, a protocol of physical exercise, with increasing levels of intensity. Patients who meet the inclusion criteria will be randomized through an online program (randomizer.org) and the ERIC protocol will be applied to the test group. The control group will be implemented the usual care of rehabilitation nursing. The ERIC protocol comprises 5 levels of intensity, as following shown:
Stage 1 - respiratory and calisthenic exercises (5-10 minutes) Stage 2 - pedaler for 5-10 minutes Stage 3 - aerobic training: walking on the corridor for 5-10 minutes Stage 4 - aerobic training: walking on the corridor for 10-15 minutes Stage 5 - aerobic training: walking on the corridor for 15 minutes + climbing stairs for 5 minutes
All patients will be monitored and followed up by a rehabilitation nurse while they are doing the exercise. The investigator decides, depending on the patient's performance and clinical conditions, the form of progression in the program, but it is mandatory to follow the previously defined levels of intensity. Patients in the test group may start the program only on stage I or II according to clinical criteria.
At admission of the patients (test group and control group) clinical and sociodemographic parameters are evaluated, as well as data related to Barthel's indices and London Chest of activities of daily living (LCADL). At the discharge date, the Barthel index and the LCADL scale will also be evaluated, as well as the 6-minute walking test.
- Being tested
- ERIC protocol
- Keywords
- Exercise, Nursing rehabilitation, Functional capacity, Heart failure
- Medical subject headings
- Motor Activity, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERIC protocolOther
ERIC protocol is an aerobic exercise protocol with 5 levels of intensity
| Study group | Role | What they receive |
|---|---|---|
| Training group | Experimental | Patients admitted due to decompensated heart failure who will perform the training protocol - ERIC protocol Receives: Other: ERIC protocol |
| Control group | No intervention | Patients admitted due to decompensated heart failure who will perform the standard rehabilitation nursing care for this type of patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walking test
Number of meters walked in the 6 minute walking test
Measured: Through study completion, an average of 1 year
Secondary outcomes (3)
Barthel Index score
Barthel evaluates dependence on self-care, it ranges from 0 to 100. The higher score inidcates more independence on the performance of self-care activities
Measured: Through study completion, an average of 1 yeare
London Chest Activity of Daily Living scale score
LCADL acesses how dyspnea affects self-care. It ranges from 9 to 45, the lower scores represents less dyspnea during the activities, representing a better status.
Measured: Through study completion, an average of 1 year
Cardiac adverse events
Number of adverse events occured during in the training group
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start2 Dec 2017
- Primary completion31 Jul 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompensated 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Miguel Delgado, Centro Hospitalar do Porto
- Investigators
- Bruno Delgado, MsC, Principal investigator, Centro Hospitalar do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733365
- Sponsor's protocol ID
- 2016.172
- Acronym
- ERIC
- Status last verified
- Jan 2021
- First submitted
- 13 Nov 2017
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nursing Rehabilitation on Patients Admitted by Recently Decompensated Heart Failure (ERIC Program) - Impact of Exercise
- ClinicalTrials.gov ID
- NCT04733365
- Acronym / sponsor ID
- ERIC / 2016.172
- Keywords
- Exercise, Nursing rehabilitation, Functional capacity, Heart failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Centro Hospitalar do PortoUniversity, hospital or other
- Study start
- 2 Dec 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 2 Feb 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.
An aerobic physical exercise protocol will be applied to patients admitted in ward due to decompensated heart failure, in order to validate the efficacy and safety of physical exercise in this phase of clinical stabilization, through the said training protocol - ERIC program.
Detailed description
With the objective of validating the efficacy and safety of physical exercise as a therapeutic resource in patients admitted for decompensated heart failure; will be applied, by rehabilitation nurses, a protocol of physical exercise, with increasing levels of intensity. Patients who meet the inclusion criteria will be randomized through an online program (randomizer.org) and the ERIC protocol will be applied to the test group. The control group will be implemented the usual care of rehabilitation nursing. The ERIC protocol comprises 5 levels of intensity, as following shown:
Stage 1 - respiratory and calisthenic exercises (5-10 minutes) Stage 2 - pedaler for 5-10 minutes Stage 3 - aerobic training: walking on the corridor for 5-10 minutes Stage 4 - aerobic training: walking on the corridor for 10-15 minutes Stage 5 - aerobic training: walking on the corridor for 15 minutes + climbing stairs for 5 minutes
All patients will be monitored and followed up by a rehabilitation nurse while they are doing the exercise. The investigator decides, depending on the patient's performance and clinical conditions, the form of progression in the program, but it is mandatory to follow the previously defined levels of intensity. Patients in the test group may start the program only on stage I or II according to clinical criteria.
At admission of the patients (test group and control group) clinical and sociodemographic parameters are evaluated, as well as data related to Barthel's indices and London Chest of activities of daily living (LCADL). At the discharge date, the Barthel index and the LCADL scale will also be evaluated, as well as the 6-minute walking test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training group | Experimental | Other: ERIC protocolPatients admitted due to decompensated heart failure who will perform the training protocol - ERIC protocol |
| Control group | No intervention | –Patients admitted due to decompensated heart failure who will perform the standard rehabilitation nursing care for this type of patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Admission diagnosis of Decompensated heart failure
- More than 18 years old
- Capacity to provide informed consent
Key exclusion criteria (7 listed)
- Osteoarticular pathology that impedes the performance of the exercise;
- Existence of inotropic infusions;
- Dysrhythmia or precordial pain in the last 24 hours,
- Acute pulmonary edema in the last 12 hours,
- SBP greater than 180mmHg or less than 80 mmHg (except in cases where this is the baseline value for the patient),
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 |
|---|---|---|
| ERIC protocolERIC protocol is an aerobic exercise protocol with 5 levels of intensity | Other | Training group |
Primary outcome
6 minute walking test
Time frame: Through study completion, an average of 1 year
Number of meters walked in the 6 minute walking test
3 secondary outcomes
Barthel Index score
Time frame: Through study completion, an average of 1 yeare
London Chest Activity of Daily Living scale score
Time frame: Through study completion, an average of 1 year
Cardiac adverse events
Time frame: Through study completion, an average of 1 year
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 2 Feb 2021.
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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.
Bruno Delgado, MsC principal investigator
Centro Hospitalar do Porto
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERIC protocol in people with Decompensated Heart Failure and Functional Cardiac Disorder, run by Centro Hospitalar do Porto at 3 sites in Portugal.
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 3 inclusion and 7 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 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Portugal. 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?
6 minute walking test (time frame: Through study completion, an average of 1 year). 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 2 Feb 2021.