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

July 13, 2026 updated by: Centro Universitário Augusto Motta

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Brazil
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brazil, 20551-030
        • Hospital Universitário Pedro Ernesto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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).
Time Frame: 90 days after discharge from the ICU
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).
Time Frame: 90 days after discharge from the ICU
90 days after discharge from the ICU

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
All-cause mortality within 90 days of discharge
Time Frame: 90 days after discharge from the ICU
90 days after discharge from the ICU
Readmission due to HF within 90 days after discharge
Time Frame: 90 days after discharge from the ICU
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
Time Frame: 90 days after discharge from the ICU
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
Time Frame: In the 48 hours prior to discharge from the ICU
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)
Time Frame: In the 48 hours prior to discharge from the ICU
In the 48 hours prior to discharge from the ICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centro Universitário Augusto Motta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 16, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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