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Exercise in Patients Admitted With Recently Decompensated Heart Failure

Nursing Rehabilitation on Patients Admitted by Recently Decompensated Heart Failure (ERIC Program) - Impact of Exercise

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04733365
Acronym
ERIC
Enrollment
250
Registered
2021-02-02
Start date
2017-12-02
Completion date
2019-12-31
Last updated
2021-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decompensated Heart Failure, Functional Cardiac Disorder

Keywords

Exercise, Nursing rehabilitation, Functional capacity, Heart failure

Brief 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.

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.

Interventions

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

Sponsors

Centro Hospitalar do Porto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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, * 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,

Design outcomes

Primary

MeasureTime frameDescription
6 minute walking testThrough study completion, an average of 1 yearNumber of meters walked in the 6 minute walking test

Secondary

MeasureTime frameDescription
Barthel Index scoreThrough study completion, an average of 1 yeareBarthel evaluates dependence on self-care, it ranges from 0 to 100. The higher score inidcates more independence on the performance of self-care activities
London Chest Activity of Daily Living scale scoreThrough study completion, an average of 1 yearLCADL 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.
Cardiac adverse eventsThrough study completion, an average of 1 yearNumber of adverse events occured during in the training group

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026