RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-07-02
Study Completion:2026-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06853236

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * A recent significant change in resting ECG
  2. * Unstable angina
  3. * Uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise
  4. * Symptomatic severe aortic stenosis
  5. * Uncontrolled symptomatic heart failure
  6. * Acute pulmonary embolus or pulmonary infarction
  7. * Acute myocarditis or pericarditis
  8. * Suspected or known dissecting aneurysm
  9. * Acute systemic infection accompanied by fever, body aches, or swollen lymph glands
  10. * Left Main Coronary Stenosis
  11. * Moderate stenotic valvular heart disease
  12. * Electrolyte abnormalities
  13. * Severe arterial hypertension (\>200 systolic, \>110 diastolic) at rest
  14. * Tachydysrhythmia or bradydysrhythmia
  15. * Hypertrophic cardiomyopathy and other forms of outflow tract obstruction
  16. * Neuromuscular, musculoskeletal, or rheumatic disorders that are exacerbated by exercise
  17. * High degree AV block
  18. * Ventricular aneurysm
  19. * Uncontrolled metabolic disease (diabetes, thyrotoxicosis, or myxedema)
  20. * Chronic infectious disease (hepatitis, AIDS, mono)
  21. * Mental or physical impairment leading to inability to exercise adequately

Contacts and Locations

Study Contact

Research Associate Senior
CONTACT
859-323-5438
delong2@uky.edu
Primary Investigator
CONTACT
859-218-0596
kpmaye2@uky.edu

Study Locations (Sites)

Florida Atlantic University
Boca Raton, Florida, 33431
United States
Duke University
Durham, North Carolina, 27708
United States

Collaborators and Investigators

Sponsor: University of Kentucky

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 Registration Dates

Study Start Date2024-07-02
Study Completion Date2026-02-28

Study Record Updates

Study Start Date2024-07-02
Study Completion Date2026-02-28

Terms related to this study

Keywords Provided by Researchers

  • Cardio respiratory fitness
  • incremental step test
  • validity
  • reliability
  • physical function
  • graded exercise testing

Additional Relevant MeSH Terms

  • Intensive Care Medicine
  • Acute Care Medical