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OpenTrials
Completed

NCT Number: NCT04733365

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Infante D Pedro, Aveiro, Portugal

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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 - 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.

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,
  • 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,

Treatment and study plan

ERIC protocol

Other

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 yeare

    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

  2. London Chest Activity of Daily Living scale score

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

    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.

  3. Cardiac adverse events

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

    Number of adverse events occured during in the training group

Sponsors and collaborators

Lead sponsor

Centro Hospitalar do Porto

Other

Registry information

Official study title

Nursing Rehabilitation 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 2, 2021
Registry last updated
Feb 2, 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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