The Alfred Step Test Exercise Protocol (A-STEP), for Adults With Cystic Fibrosis.

Launched by THE ALFRED · Mar 18, 2016

Keywords

ClinConnect Summary

The Alfred Step Test Exercise Protocol (A-STEP) trial is studying a new exercise test designed specifically for adults with Cystic Fibrosis (CF). The goal is to create a simple and effective step test that can help doctors assess how well patients can exercise, which is important for understanding their health and managing their care. This test aims to be easier to use than traditional lab tests and could help detect any decline in physical function earlier in everyday clinical settings.

To participate in this trial, individuals must be at least 18 years old and have a confirmed diagnosis of Cystic Fibrosis, with stable lung function (meaning no recent hospitalizations or changes in treatment). Participants should generally be in stable health, with enough lung capacity to safely engage in the exercise test. Those with certain health issues, like uncontrolled asthma or significant heart problems, would not be eligible. By joining this study, participants can contribute to advancing our understanding of exercise tolerance in CF and potentially benefit from improved monitoring of their condition.

Gender

ALL

Eligibility criteria

• • INCLUSION
• • Confirmed Diagnosis of CF (by genotype or positive sweat test)
• • Aged 18yrs and older
• • FEV1 ≥20% (Forced expiration in 1 sec)
• • Stable baseline state. (Stable baseline state is defined as: clinically stable respiratory status, for at least 30 days, characterized by the absence of hospitalization and no changes in maintenance therapy during this period (Yankaskas et al 2004)).
• • EXCLUSION
• • Febrile
• • Haemoptysis
• • Uncontrolled asthma
• • Pneumothorax
• • Cardiac issues
• • Unreliable readings on pulse oximetry
• • Pulmonary hypertension
• • Unstable CF related diabetes (CFRD)
• • Vascular issues
• • Renal disease
• • Pregnancy
• • Body mass index (BMI) \<18.0
• • Significant musculoskeletal issues
• • Unable to safely follow instructions
• • (ATS/ACCP 2003; Hebestreit 2015)