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

Association Between Performance in the 1-Minute Sit-To-Stand Test and Clinical and Functional Outcomes of Patients Hospitalized for Heart Failure - Prospective Observational Study

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Heart Failure NYHA Class II; Heart Failure NYHA Class III; Heart Failure NYHA Class IV; Heart Failure; With Decompensation
• Intervention / Treatment: Diagnostic test: 1-minute sit-to-stand test

Detailed Description

This is a prospective cohort study analyzing the association between TSL1 performance and clinical and functional outcomes within 90 days after discharge of patients who were hospitalized for CDI between June 2025 and October 2025. Data will be collected by the researcher and the institution's senior physiotherapist team, and the team will be trained to reduce the risk of bias. A document form will be made available for completion during the evaluation, and sociodemographic data will also be collected from the electronic medical record.

• Study Type: Observational
• Enrollment (Estimated): 68

Contacts and Locations

• Study Contact: Name: Daiane Nascimento Camêlo, Master's student; Phone Number: +55 (21) 99452-1787; Email: daianecamelo@souunisuam.com.br

Study Locations

• Brazil
  • Rio De Janeiro, Brazil, 20551-030
    • Recruiting
    • Hospital Universitário Pedro Ernesto
    • Contact: Daiane Camêlo, Physiotherapist; Phone Number: +55 (21) 99452-1787; Email: DAIANENASCIMENTO195@GMAIL.COM
    • Contact: Carolina Nigro, Physiotherapist; Phone Number: +55 (21) 99804-3470; Email: caroll_nigro@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with CDI

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Centro Universitário Augusto Motta

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: May 12, 2025
• First Submitted That Met QC Criteria: June 22, 2025
• First Posted (Actual): July 1, 2025

Study Record Updates

• Last Update Posted (Actual): July 23, 2025
• Last Update Submitted That Met QC Criteria: July 18, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Prognosis; Hospitalization; Functional Status
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 87791825.8.0000.5235

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No