Reproducibility of Virtual Exercise Assessments Versus Face-to-face Exercise Testing in Adults With Cystic Fibrosis

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Procedure: One-Minute Sit-to-Stand Test; Procedure: Chester Step Test

• Registration Number: NCT06565832
• Lead Sponsor: Royal Brompton & Harefield NHS Foundation Trust

Brief Summary

RExA-CF is investing if results from exercise tests (the Chester Step Test and the One-Minute Sit-to-Stand test) completed face to face are comparable to results of the same tests completed via a virtual teleconferencing platform. The study involves two exercise testing sessions (one face-to-face and one via a video link), with participants being randomised to complete the two exercise tests (the 1-minute sit-to-stand test and the Chester Step test). The two testing sessions will be completed within three weeks of each other, the order of which will be randomly allocated. One session will be completed face-to-face during a pre-arranged visit to the hospital, the other test session will be completed through a video call at a time convenient to the participants. After the second testing session participants will be asked some questions about the face-to-face and video tests to get their views about the two formats.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-01
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-14
• Study First Submitted QC: 2024-08-21
• Last Update Submitted: 2024-08-21
• Study First Posted: 2024-08-22
• Last Update Posted: 2024-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Diagnosis of cystic fibrosis (as confirmed by standard criteria)
• Sixteen years of age or over
• Home internet access
• Stable CF disease as judged by the medical team
• Registered with the Royal Brompton Hospital adult CF team

Exclusion Criteria

• Inability to give consent for treatment or measurement
• Current participation in another interventional study
• Current moderate haemoptysis (greater than streaking in the sputum)
• Pregnancy
• Forced expiratory volume in 1 second (FEV1) below 30% predicted
• Dependency upon oxygen therapy (with home oxygen concentrators or portable oxygen cylinders) or non-invasive ventilation (NIV)
• Current neurological or musculoskeletal injury which would prevent completion of exercise tests
• Inability to complete the second set of exercise tests within three weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Virtual exercise testing via video link	One-Minute Sit-to-Stand Test	The One-Minute Sit-to-Stand test and the Chester Step test will be completed via a video link call with the participant and the research team.
Virtual exercise testing via video link	Chester Step Test	The One-Minute Sit-to-Stand test and the Chester Step test will be completed via a video link call with the participant and the research team.
Face-to-Face exercise testing	One-Minute Sit-to-Stand Test	The One-Minute Sit-to-Stand test and the Chester Step test will be completed face to face at a hospital appointment with the participant and the research team.
Face-to-Face exercise testing	Chester Step Test	The One-Minute Sit-to-Stand test and the Chester Step test will be completed face to face at a hospital appointment with the participant and the research team.

Primary Outcome Measures

Name	Time	Method
Aerobic Capacity from the Chester Step test	Completed at week 0 and within 2 weeks of first test	This test involves the participant stepping up and down off of a step (this can be a bottom stair or doorstep at home) keeping up with the beat of a recording. The speed of the beat increases every 2 minutes, and the test continues until the participant cannot keep up with the pace, wish to stop or the test ends which takes 10 minutes. Participants will be asked to take their heart rate and oxygen levels before and after the test using a provided pulse-oximeter. This test should take a maximum of 15 minutes. The results of the test will be used to calculate the participants aerobic capacity (range 0-60)
Number of sit to stands completed during One-Minute Sit-to-Stand test	Completed at week 0 and within 2 weeks of first test	This test involves the participant sitting down and standing up from a normal height chair (can be a dining room or kitchen chair at home) for one minute. Participants can rest or stop at any time if fatigued. This test should take a maximum of 5 minutes.

Trial Locations

Locations (1)

Royal Brompton Hospital, Guy's and St Thomas's NHS Foundation Trust; 🇬🇧 London, United Kingdom