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临床试验/NCT06853236
NCT06853236进行中(未招募)不适用

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

Kirby Mayer5 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年7月2日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
Kirby Mayer
入组人数
60
试验地点
5
主要终点
Modified Bruce Treadmill VO2 Peak

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Chronic Pulmonary Disease

Community-dwelling adults with diagnosis of COPD, ILD, or PF

Healthy

Community-dwelling older adults (≥60 years) with no recent hospitalization

ICU Survivor

Patients who survived ICU admission for ARF or sepsis in the last year

结局指标

主要结局

Modified Bruce Treadmill VO2 Peak

时间窗: Upon enrollment at baseline (day 0-7)

Peak oxygen consumption during the modified Bruce cardiorespiratory test using a PARVO metabolic cart

F-IST VO2 Peak

时间窗: Upon enrollment at baseline (day 0-7)

Peak oxygen consumption during the F-IST cardiorespiratory test using a PARVO metabolic cart

F-IST VO2 Peak Reliability

时间窗: Approximately 1-2 weeks following baseline (day 14-21)

Peak oxygen consumption during the F-IST cardiorespiratory test using a PARVO metabolic cart

次要结局

  • 4m habitual gait speed(Approximately 1-2 weeks following baseline (day 14-21))
  • 6MWT distance(Approximately 1-2 weeks following baseline (day 14-21))
  • Sit to Stand Test (5x)(Approximately 1-2 weeks following baseline (day 14-21))
  • Visual Analog Scale Questionnaire(Approximately 1-2 weeks following baseline (day 14-21))
  • Sit to Stand Test (30 seconds)(Approximately 1-2 weeks following baseline (day 14-21))
  • EQ5D-5L Questionnaire(Approximately 1-2 weeks following baseline (day 14-21))
  • FACIT-fatigue Questionnaire(Approximately 1-2 weeks following baseline (day 14-21))
  • SF-36 Questionnaire(Approximately 1-2 weeks following baseline (day 14-21))
  • St. George's Respiratory Questionnaire(Approximately 1-2 weeks following baseline (day 14-21))

研究者

发起方
Kirby Mayer
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kirby Mayer

Associate Professor

University of Kentucky

研究点 (5)

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