Меню
Идёт набор NCT06853236

Functional Incremental Stepping in Place Test (F-IST) Validation

Наблюдательное Intensive Care Medicine Acute Care Medical

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Intensive Care Medicine, Acute Care Medical. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

A Cardiorespiratory Fitness Test for Acute Illness: Validity, Reliability, and Clinical Utility of Functional Incremental Stepping-in-Place Test

Обзор

The purpose of this multi-site prospective study is to assess validity of a new step test called Functional-Incremental Stepping-in-place- Test (F-IST) compared to gold-standard cardiopulmonary exercise testing (CPET) and to physical function and health perception, respectively. The investigators will also assess test-retest reliability of the F-IST. The investigators hypothesize that the F-IST will have high validity and test-retest reliability to be used in field testing environments such as the ICU.

Подробное описание

Acutely hospitalized patients are at risk for hospital-acquired functional decline (HAD). This decline increases the likelihood of developing physical disability after discharge, particularly in those with older age, multimorbidity, pre-existing functional impairment and life support exposures (i.e. mechanical ventilation). Identifying patients at increased risk provides important prognostic data to inform planning strategies for both in-hospital and post-acute intervention.

Common physiological consequences associated with HAD are diminished skeletal muscle function and cardiorespiratory fitness (CRF). Historically, the six-minute walk test (6MWT) has been utilized as a chief outcome measure in the acute hospitalization and post-discharge phases to examine functional exercise capacity, estimate maximal capacity, and prescribe exercise intervention. The 6MWT is a submaximal field test that allows patients to self-select their walking pace and may be influenced by several factors including motivation. The internally-selected pace coupled with the lack of incremental increases in intensity can underrepresent CRF. In addition, the test requires a 30-meter straight course, which can be challenging to find in the hospital environment. Thus, to address the limitations of submaximal field tests, our team developed the Functional-Incremental Stepping-in-place Test (F-IST).

Designed to objectively examine CRF across the variety of patients encountered in clinical practice, the F-IST is an incremental, externally-paced, symptom-limited stepping-in-place test. While maintaining the graded components of gold standard cardiopulmonary exercise testing (CPET), it has high clinical utility since it requires minimal equipment (UE support allowed), minimal space (performed at bedside), and short administration time (\< 10 min). Also, the incremental increase in intensity is individualized to perceived exertion and heart rate responses during test stages, which ultimately enables precise exercise prescription. Preliminary data on F-IST from the ongoing randomized controlled trial (NCT05218083) demonstrate potential for strong construct validity when compared to 6MWT (n = 9, spearman rho = 0.65, p = 0.05). However, before implementation in clinical practice, a new test requires the study of its measurement properties to assure that its selection is evidence-based.

Findings from this study will demonstrate that F-IST is a robust valid and reliable assessment of CRF that can be implemented on the frontline of acute care physical therapy. The F-IST addresses important limitations of field tests with an enhanced rigor by maintaining principles of gold-standard CPET. The F-IST will enable clinicians and researchers to provide precision exercise prescription to optimize patient function.

Первичные конечные точки

  • Modified Bruce Treadmill VO2 Peak [Срок оценки: Upon enrollment at baseline (day 0-7)]
  • F-IST VO2 Peak [Срок оценки: Upon enrollment at baseline (day 0-7)]
  • F-IST VO2 Peak Reliability [Срок оценки: Approximately 1-2 weeks following baseline (day 14-21)]
Вторичные конечные точки (9)
  • 6MWT distance [Срок оценки: Approximately 1-2 weeks following baseline (day 14-21)]
  • 4m habitual gait speed [Срок оценки: Approximately 1-2 weeks following baseline (day 14-21)]
  • Sit to Stand Test (5x) [Срок оценки: Approximately 1-2 weeks following baseline (day 14-21)]
  • Sit to Stand Test (30 seconds) [Срок оценки: Approximately 1-2 weeks following baseline (day 14-21)]
  • EQ5D-5L Questionnaire [Срок оценки: Approximately 1-2 weeks following baseline (day 14-21)]
  • Visual Analog Scale Questionnaire [Срок оценки: Approximately 1-2 weeks following baseline (day 14-21)]
  • FACIT-fatigue Questionnaire [Срок оценки: Approximately 1-2 weeks following baseline (day 14-21)]
  • SF-36 Questionnaire [Срок оценки: Approximately 1-2 weeks following baseline (day 14-21)]
  • St. George's Respiratory Questionnaire [Срок оценки: Approximately 1-2 weeks following baseline (day 14-21)]

Критерии участия

Критерии включения

-Currently able to walk with or without a walking aid, such as a cane or walker or rollator

Критерии исключения

Pregnancy

specifically related to cardiopulmonary testing

  • A recent significant change in resting ECG
  • Unstable angina
  • Uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise
  • Symptomatic severe aortic stenosis
  • Uncontrolled symptomatic heart failure
  • Acute pulmonary embolus or pulmonary infarction
  • Acute myocarditis or pericarditis
  • Suspected or known dissecting aneurysm
  • Acute systemic infection accompanied by fever, body aches, or swollen lymph glands
  • Left Main Coronary Stenosis
  • Moderate stenotic valvular heart disease
  • Electrolyte abnormalities
  • Severe arterial hypertension (>200 systolic, >110 diastolic) at rest
  • Tachydysrhythmia or bradydysrhythmia
  • Hypertrophic cardiomyopathy and other forms of outflow tract obstruction
  • Neuromuscular, musculoskeletal, or rheumatic disorders that are exacerbated by exercise
  • High degree AV block
  • Ventricular aneurysm
  • Uncontrolled metabolic disease (diabetes, thyrotoxicosis, or myxedema)
  • Chronic infectious disease (hepatitis, AIDS, mono)
  • Mental or physical impairment leading to inability to exercise adequately

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

США · 2 центра
  • Florida Atlantic University — Boca Raton
  • Duke University — Durham

Идентификаторы

NCT: NCT06853236 · 86390 · 1000400362

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗