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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03838003
Other study ID # ERIC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2017
Est. completion date September 30, 2019

Study information

Verified date September 2017
Source Universidade do Porto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 250
Est. completion date September 30, 2019
Est. primary completion date March 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Procedure:
ERIC protocol
ERIC protocol is an aerobic exercise protocol with 5 levels of intensity

Locations

Country Name City State
Portugal Centro Hospitalar do Porto Oporto

Sponsors (3)

Lead Sponsor Collaborator
Universidade do Porto Centro Hospitalar do Porto, Instituto Politécnico de Bragança

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary 6 minute walking test Number of meters walked in the 6 minute walking test through study completion, an average of 1 year
Secondary Barthel Index score Barthel evaluates dependence on self-care through study completion, an average of 1 year
Secondary London Chest Activity of Daily Living (LCADL) scale score LIDL accesses how dyspnea affects self-care through study completion, an average of 1 year
Secondary Number of dysrhythmias during exercise in the training group To quantify the number of dysrhythmias during exercise in the training group through study completion, an average of 1 year
Secondary Number of falls during exercise in the training group To quantify the number of falls during exercise in the training group through study completion, an average of 1 year
Secondary Number of emergency situations during exercise in the training group To quantify the number of emergency situations during exercise in the training group through study completion, an average of 1 year
Secondary Number of chest pain situations during exercise in the training group To quantify the chest pain situations during exercise in the training group through study completion, an average of 1 year
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