Heart FailureNCT07045649
Association Between the Sit-To-Stand Test and the Prognosis of Patients With Heart Failure
An observational study of Heart Failure and Heart Failure NYHA Class IV, run by Centro Universitário Augusto Motta at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Heart Failure NYHA Class IV, Heart Failure; With Decompensation
- What is being tested?
- 1-minute sit-to-stand test
- How many people
- 68 participants
- Where
- 1 siteBrazil
- Study dates
- 16 Jul 2025to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with CDI
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Universitário Pedro Ernesto
Rio de Janeiro, Rio de Janeiro, 20551-030
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure, Heart Failure NYHA Class IV, Heart Failure; With Decompensation, Heart Failure NYHA Class III, Heart Failure NYHA Class II
- Being tested
- 1-minute sit-to-stand test
- Keywords
- Functional Status, Hospitalization, Prognosis
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-minute sit-to-stand testDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: 1-minute sit-to-stand test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 90 days after discharge from the ICU
Secondary outcomes (5)
All-cause mortality within 90 days of discharge
Measured: 90 days after discharge from the ICU
Readmission due to HF within 90 days after discharge
Measured: 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
Measured: 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
Measured: 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)
Measured: In the 48 hours prior to discharge from the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start16 Jul 2025
- Primary completionJul 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Universitário Augusto Motta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045649
- Sponsor's protocol ID
- 87791825.8.0000.5235
- Status last verified
- Jul 2025
- First submitted
- 12 May 2025
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07045649
- Acronym / sponsor ID
- 87791825.8.0000.5235
- 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
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Centro Universitário Augusto MottaUniversity, hospital or other
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1-minute sit-to-stand test | – | Diagnostic Test: 1-minute sit-to-stand testThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with CDI
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1-minute sit-to-stand testThe 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 |
Primary outcome
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
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
5 secondary outcomes
All-cause mortality within 90 days of discharge
Time frame: 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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Heart Failure NYHA Class IV, run by Centro Universitário Augusto Motta at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.