NCT02717650: A-STEP

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

Completed NA Last updated 11 August 2025

What this trial tests

NA trial testing A-STEP in Cystic Fibrosis in 7 participants. Completed in 4 March 2024.

Timeline

25 August 2016

Primary endpoint
4 March 2024

4 March 2024

Quick facts

Lead sponsor	The Alfred
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Primary purpose	basic science
Enrollment	7
Start date	25 August 2016
Primary completion	4 March 2024
Estimated completion	4 March 2024
Sites	1 location across Australia

Drugs / interventions tested

• A-STEP
• A-STEP (New Protocol)
• Comparator: CPET cycle ergometer (Gold Standard)

Conditions studied

• Cystic Fibrosis — all drugs for Cystic Fibrosis →
• Fibrosis — all drugs for Fibrosis →
• Lung Diseases — all drugs for Lung Diseases →
• Respiratory Diseases — all drugs for Respiratory Diseases →

Sponsor

The Alfred — full company profile →

Who can join

18 and older, any sex, with Cystic Fibrosis or Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Exercise testing has become clinically important in the management and ongoing evaluation of patients with Cystic Fibrosis (CF) with higher rates of exercise tolerance and participation previously linked to lower mortality risk (1).

Lower exercise capacity generally correlates with more severe lung disease (2,3) and landmark studies suggest that low exercise capacity as measured by peak oxygen capacity (VO2peak) and rate of decline in lung function (FEV1) are strong predictors of mortality (1,4). However not all studies have found pulmonary function tests (PFTs) to be reliable predictors of maximal exercise capacity (5), especially in relatively well preserved lung function (6,7).

The wide distribution in physical capacity between fit individuals and end stage disease adds to complexity of assessment. Independent factors of age, genetics, habitual exercise, nutritional status and musculoskeletal conditions are all known to influence physical capacity in patients with CF (8,9).

Maximal exercise testing places additional stress on cardiovascular, respiratory and peripheral systems providing more information around multiple influences on disease progression including degree of limitation in these major systems (10,11) and is useful for assessment of exercise desaturation, more common (but not always present) in advanced lung disease (5,12).

With prediction of exercise performance and functional capacity from PFTs unreliable and the understanding that health status correlates better with exercise tolerance there has been an increase in maximal exercise testing for patient management (13). Many international centers now regard exercise testing as highly important with many assessing maximal exercise capacity annually to monitor disease progression, identify physical status and drive changes in medical, physiotherapy or nutritional management (14,15).

The main vision is to develop a standardized incremental step test protocol suitable for adults with Cystic Fibrosis (CF), all ages, levels of fitness and disease state that is in line with current exercise testing recommendations (15). To develop a more useful field test to assess exercise tolerance and a more "user friendly" test than the currently available laboratory exercise test to allow for early detection of decline in physical function in the day-to-day clinical setting. To date no studies have been published in adults with CF where an incremental exercise step test has been investigated to assess exercise tolerance or determine maximum oxygen uptake (VO2max).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The potentially beneficial central nervous system activity profile of ivacaftor and its metabolites.
   Schneider EK, McQuade RM, Carbone VC, Reyes-Ortega F, et al · · 2018 · cited 30× · PMID 29560360 · DOI 10.1183/23120541.00127-2017
2. Feasibility of the A-STEP for the assessment of exercise capacity in people with cystic fibrosis.
   Wilson LM, Potter A, Maher C, Ellis MJ, et al · · 2022 · cited 3× · PMID 35811327 · DOI 10.1002/ppul.26069