Association Between the Sit-To-Stand Test and the Prognosis of Patients With Heart Failure

NCT07045649 | Recruiting DMC

• 1 other identifier: 87791825.8.0000.5235
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Heart failure (HF), among cardiovascular diseases, is the disease that has been increasing its incidence and prevalence the most in recent years in the world population, due to the aging of the population. In addition, HF is the most frequent hospital diagnosis in the elderly, and is the main cause of hospitalization, with significant expenditure in public and private health care worldwide. Some functional tests have been used to predict the prognosis in patients with HF, however, the use of the 1-minute sit-to-stand test (SST1) to predict prognosis in HF has little scientific evidence, due to the lack of studies found in the literature for this population. Thus, the present study aims to evaluate the association between SST1 at discharge from the Cardio Intensive Care Unit (ICU) and the clinical outcome after 90 days in patients hospitalized for decompensated heart failure (DHF). Methods: This is a prospective cohort study analyzing the association between performance on the TSL1 and clinical outcome in patients hospitalized for DHF from June 2025 to October 2025. Sociodemographic, family, social, and clinical data will be collected from the participants, after which the TSL1 will be performed. The outcome of death and hospital readmission within 90 days after discharge from the ICU will be identified through telephone contact, which will be carried out by the researcher. Expected results: It is expected that from the results of this study it will be possible to understand whether performance on the TSL1 predicts clinical outcome for patients hospitalized for DHF and that it will even be possible to determine a cutoff point capable of predicting the outcomes of interest.

Conditions

Heart Failure; Heart Failure NYHA Class IV; Heart Failure; With Decompensation; Heart Failure NYHA Class III; Heart Failure NYHA Class II

Keywords

Functional Status; Hospitalization; Prognosis

Outcome Measures

Primary Outcomes (2)

• Occurrence of mortality for any cause within 90 days after discharge from the Cardiac Intensive Care Unit (ICU) in patients hospitalized for decompensated heart failure (DHF).

  90 days after discharge from the ICU

• Number of readmission for any cause within 90 days after discharge from the Cardiac Intensive Care Unit (ICU) in patients hospitalized for decompensated heart failure (DHF).

  90 days after discharge from the ICU

Secondary Outcomes (5)

• All-cause mortality within 90 days of discharge

  90 days after discharge from the ICU

• Readmission due to HF within 90 days after discharge

  90 days after discharge from the ICU

• Total number of days alive outside the hospital (days alive after discharge by time from occurrence to event) in the first 90 days after discharge

  90 days after discharge from the ICU

• Functional performance at the time of discharge from the ICU according to the IMS - Intensive Care Unit Mobility Scale

  In the 48 hours prior to discharge from the ICU

• Correlation between TSL-1 performance and other functional markers at discharge (FSS-ICU, IMS and handgrip strength)

  In the 48 hours prior to discharge from the ICU

Study Arms (1)

1-minute sit-to-stand test

The 1-minute sit-to-stand test will be assessed upon discharge from the Cardiac Intensive Care Unit. It may be assessed up to 48 hours after discharge from the unit. It will be performed on a standardized 46.0 cm chair without armrests, placed against the wall. Participants will be seated in the chair, without support, with their knees and hips at 90° flexion, with their feet parallel to the floor and their arms crossed over their chest. Participants will be instructed to stand up and sit down as quickly as possible without using their arms for 1 minute and will be instructed to stop whenever they wish. However, they must return as quickly as possible, since the goal is to complete as many repetitions as possible in 1 minute. Vital signs and dyspnea and leg fatigue will be assessed using the Modified Borg Scale before and after the test. A repetition will be identified as standing up completely straight and returning to the sitting position.

Diagnostic Test: 1-minute sit-to-stand test

Interventions

1-minute sit-to-stand test DIAGNOSTIC_TEST

The 1-minute sit-to-stand test will be assessed upon discharge from the Cardiac Intensive Care Unit. It may be assessed up to 48 hours after discharge from the unit. It will be performed on a standardized 46.0 cm chair without armrests, placed against the wall. Participants will be seated in the chair, without support, with their knees and hips at 90° flexion, with their feet parallel to the floor and their arms crossed over their chest. Participants will be instructed to stand up and sit down as quickly as possible without using their arms for 1 minute and will be instructed to stop whenever they wish. However, they must return as quickly as possible, since the goal is to complete as many repetitions as possible in 1 minute. Vital signs and dyspnea and leg fatigue will be assessed using the Modified Borg Scale before and after the test. A repetition will be identified as standing up completely straight and returning to the sitting position.

1-minute sit-to-stand test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with CDI

You may qualify if:

• Patients diagnosed with CDI;
• Over 18 years of age;
• With an Intensive Care Unit Mobility Scale (IMS) \> 4 at discharge from the ICU;
• Able to sit and stand up from a chair without support from the upper limbs (ULs) will be included in the study.

You may not qualify if:

• Patients with cognitive alterations;
• Level of consciousness, with \[RASS (Richmond Agitation and Sedation Scale) \>+1 or \<-2 and Glasgow \<13 (Coma Scale)\], neurological and orthopedic, which compromise the understanding and performance of the assessment will be excluded;
• Patients with advanced invasive ventilatory and circulatory support or in cardiogenic shock.

Sponsors & Collaborators

• Centro Universitário Augusto Motta: lead

Study Sites (1)

Hospital Universitário Pedro Ernesto

Rio de Janeiro, Rio de Janeiro, 20551-030, Brazil

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Daiane Nascimento Camêlo, Master's student

CONTACT

+55 (21) 99452-1787; daianecamelo@souunisuam.com.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: July 1, 2025
• Study Start: July 16, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)