Exercise testing protocol for adults with cystic fibrosis
Development; Feasibility/Safety and Validation of the Alfred Step Test Exercise Protocol (A-STEP) Developed for Adults With Cystic Fibrosis:
This study is testing a new exercise method for adults with cystic fibrosis to see if it gives better information about their physical abilities compared to the standard exercise test.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Alfred Academic / other |
| Locations | 1 site (Melbourne, Victoria) |
| Trial ID | NCT02717650 on ClinicalTrials.gov |
What this trial studies
This study evaluates a new exercise testing protocol called A-STEP for adults with cystic fibrosis, comparing it to the established cardiopulmonary exercise testing (CPET) method. The goal is to assess maximal exercise capacity and identify factors influencing exercise limitations in patients. Participants will undergo both the A-STEP protocol and CPET to determine the effectiveness and practicality of the new approach. The study aims to enhance the management of cystic fibrosis by providing better insights into patients' physical capabilities.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of cystic fibrosis and stable respiratory status.
Not a fit: Patients with severe comorbid conditions, unstable health status, or significant musculoskeletal issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management strategies for adults with cystic fibrosis, potentially enhancing their quality of life and longevity.
How similar studies have performed: Previous studies have shown the importance of exercise testing in cystic fibrosis management, indicating that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Melbourne, Victoria
- The Alfred Hospital — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Principal investigator: Lisa M Wilson, BHS(Physio) — Alfred Hospital; Monash University
- Study coordinator: Lisa M Wilson, BHS(Physio)
- Email: l.wilson@alfred.org.au
- Phone: 0390763450
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.