Exercise in Patients Admitted With Recently Decompensated Heart Failure
ERIC
Nursing Rehabilitation on Patients Admitted by Recently Decompensated Heart Failure (ERIC Program) - Impact of Exercise
1 other identifier
interventional
250
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2017
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2017
CompletedStudy Start
First participant enrolled
December 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedFirst Posted
Study publicly available on registry
February 2, 2021
CompletedFebruary 2, 2021
January 1, 2021
1.7 years
November 13, 2017
January 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
6 minute walking test
Number of meters walked in the 6 minute walking test
Through study completion, an average of 1 year
Secondary Outcomes (3)
Barthel Index score
Through study completion, an average of 1 yeare
London Chest Activity of Daily Living scale score
Through study completion, an average of 1 year
Cardiac adverse events
Through study completion, an average of 1 year
Study Arms (2)
Training group
EXPERIMENTALPatients admitted due to decompensated heart failure who will perform the training protocol - ERIC protocol
Control group
NO INTERVENTIONPatients admitted due to decompensated heart failure who will perform the standard rehabilitation nursing care for this type of patients
Interventions
ERIC protocol is an aerobic exercise protocol with 5 levels of intensity
Eligibility Criteria
You may qualify if:
- Admission diagnosis of Decompensated heart failure
- More than 18 years old
- Capacity to provide informed consent
You may not qualify if:
- 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,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Hospital Infante D Pedro
Aveiro, Portugal
Hospital Pulido Valente
Lisbon, Portugal
Centro Hospitalar de Vila Nova de Gaia
Vila Nova de Gaia, Portugal
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bruno Delgado, MsC
Centro Hospitalar do Porto
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Nurse
Study Record Dates
First Submitted
November 13, 2017
First Posted
February 2, 2021
Study Start
December 2, 2017
Primary Completion
July 31, 2019
Study Completion
December 31, 2019
Last Updated
February 2, 2021
Record last verified: 2021-01