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Completed

NCT Number: NCT03838003

Exercise in Patients Admitted With Recently Decompensated Heart Failure

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.

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Key information

Conditions

Decompensated Heart Failure Behavior Cardiovascular Diseases Functional Cardiac Disorder Heart Diseases Heart Failure Motor Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Hospitalar do Porto

Porto, 4000, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ERIC protocol

Procedure

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

Primary outcomes

  1. 6 minute walking test

    Time frame: through study completion, an average of 1 year

    Number of meters walked in the 6 minute walking test

Secondary outcomes

  1. Barthel Index score

    Time frame: through study completion, an average of 1 year

    Barthel evaluates dependence on self-care

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Universidade do Porto

Other

Collaborators

  • Centro Hospitalar do Porto
  • Instituto Politécnico de Bragança

Registry information

Official study title

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

Acronym: ERIC

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 12, 2019
Registry last updated
Sep 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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