1-minute sit-to-stand test to predict outcomes in people 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
Centro Universitário Augusto Motta · NCT07045649
The team will test whether the 1-minute sit-to-stand test at ICU discharge can predict 90-day outcomes for adults hospitalized with decompensated heart failure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 68 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centro Universitário Augusto Motta (other) |
| Locations | 1 site (Rio de Janeiro, Rio de Janeiro) |
| Trial ID | NCT07045649 on ClinicalTrials.gov |
What this trial studies
This prospective cohort will enroll adults hospitalized for decompensated heart failure and perform a 1-minute sit-to-stand test (SST1) at discharge from the Cardio ICU. Performance on the SST1 will be recorded by trained researchers and the unit's senior physiotherapy team using a standardized form and linked to sociodemographic and clinical data from electronic records. Patients will be followed for 90 days after discharge to capture clinical and functional outcomes, including rehospitalization and mortality. Patients with cognitive impairment, inability to perform the test, ongoing invasive ventilatory or circulatory support, or cardiogenic shock are excluded to ensure safety and test validity.
Who should consider this trial
Good fit: Adults hospitalized for decompensated heart failure who can sit and stand without arm support, have an ICU Mobility Scale >4 at ICU discharge, and can follow instructions are ideal candidates.
Not a fit: Patients with significant cognitive impairment, low consciousness, ongoing invasive ventilatory or circulatory support, cardiogenic shock, or those unable to perform the sit-to-stand safely are unlikely to benefit.
Why it matters
Potential benefit: If successful, this could give clinicians a quick, bedside tool to identify heart failure patients at higher risk of poor 90-day outcomes.
How similar studies have performed: Other functional tests have shown prognostic value in heart failure, but there is little published evidence specifically supporting the 1-minute sit-to-stand test in this population, so this application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Rio de Janeiro, Rio de Janeiro
- Hospital Universitário Pedro Ernesto — Rio de Janeiro, Rio de Janeiro, Brazil (RECRUITING)
Study contacts
- Study coordinator: Daiane Nascimento Camêlo, Master's student
- Email: daianecamelo@souunisuam.com.br
- Phone: +55 (21) 99452-1787
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure, Heart Failure NYHA Class IV, With Decompensation, Heart Failure NYHA Class III, Heart Failure NYHA Class II, Functional Status, Hospitalization, Prognosis