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Completed

NCT Number: NCT06565832

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

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Brompton Hospital, Guy's and St Thomas's NHS Foundation Trust

London, SW3 6NP, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

One-Minute Sit-to-Stand Test

Procedure

This test involves 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. Participants will be asked to record your heart rate and oxygen levels before and after the test and will be given a monitor to do this with if they do not already have one. This test should take a maximum of 5 minutes.

Chester Step Test

Procedure

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 record heart rate and oxygen levels before and after the test. This test should take a maximum of 15 minutes.

Primary outcomes

  1. Aerobic Capacity from the Chester Step test

    Time frame: 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)

  2. Number of sit to stands completed during One-Minute Sit-to-Stand test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Royal Brompton & Harefield NHS Foundation Trust

Other

Collaborators

  • King's College London

Registry information

Official study title

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

Acronym: RExA-CF

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 22, 2024
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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