- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03838003
Exercise in Patients Admitted With Recently Decompensated Heart Failure (ERIC)
Rehabilitation Nursing on Patients Admitted by Recently Decompensated Heart Failure (ERIC Program) - Impact of Exercise
Study Overview
Status
Intervention / Treatment
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 - pedal 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Oporto, Portugal, 4000
- Centro Hospitalar do Porto
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Admission diagnosis of Decompensated heart failure
- More than 18 years old
- Capacity to provide informed consent
Exclusion Criteria:
- 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
- Systolic blood pressure greater than 180millimetre of mercury (mmHg) or less than 80mmHg (except in cases where this is the baseline value for the patient)
- Need for oxygen at a rate greater than 3 /min
- Glycemic decompensation in the last 12 hours
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental: Training group
Patients admitted due to decompensated heart failure who will perform the training protocol - ERIC protocol
|
ERIC protocol is an aerobic exercise protocol with 5 levels of intensity
|
NO_INTERVENTION: No Intervention: Control group
Patients admitted due to decompensated heart failure who will perform the standard rehabilitation nursing care for this type of patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
6 minute walking test
Time Frame: through study completion, an average of 1 year
|
Number of meters walked in the 6 minute walking test
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Barthel Index score
Time Frame: through study completion, an average of 1 year
|
Barthel evaluates dependence on self-care
|
through study completion, an average of 1 year
|
London Chest Activity of Daily Living (LCADL) scale score
Time Frame: through study completion, an average of 1 year
|
LIDL accesses how dyspnea affects self-care
|
through study completion, an average of 1 year
|
Number of dysrhythmias during exercise in the training group
Time Frame: through study completion, an average of 1 year
|
To quantify the number of dysrhythmias during exercise in the training group
|
through study completion, an average of 1 year
|
Number of falls during exercise in the training group
Time Frame: through study completion, an average of 1 year
|
To quantify the number of falls during exercise in the training group
|
through study completion, an average of 1 year
|
Number of emergency situations during exercise in the training group
Time Frame: through study completion, an average of 1 year
|
To quantify the number of emergency situations during exercise in the training group
|
through study completion, an average of 1 year
|
Number of chest pain situations during exercise in the training group
Time Frame: through study completion, an average of 1 year
|
To quantify the chest pain situations during exercise in the training group
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ERIC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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