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CompletedNCT06565832RExA-CFUpdated Aug 22, 2024

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

An interventional study of One-Minute Sit-to-Stand Test and Chester Step Test in Cystic Fibrosis, sponsored by Royal Brompton & Harefield NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-08-22.

Sponsored by Royal Brompton & Harefield NHS Foundation Trust · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled May 2023, registered Aug 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
16 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Cystic Fibrosis

Keywords

  • Exercise testing
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In context

Cystic Fibrosis

1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.

This study's enrollment of 19 is below the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.

Browse Cystic Fibrosis studies →

Lead sponsor

Royal Brompton & Harefield NHS Foundation Trust is the lead sponsor of 137 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Active comparator
    Virtual exercise testing via video link

    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.

    Procedure: One-Minute Sit-to-Stand Test · Procedure: Chester Step Test

  • Active comparator
    Face-to-Face exercise testing

    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.

    Procedure: One-Minute Sit-to-Stand Test · Procedure: Chester Step Test

Interventions

  • ProcedureOne-Minute Sit-to-Stand Test

    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.

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

06

What researchers measure

Primary outcomes

  1. Aerobic Capacity from the Chester Step 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)

    Time frame: Completed at week 0 and within 2 weeks of first test

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

    Time frame: Completed at week 0 and within 2 weeks of first test

07

Study locations

1 site
  • Royal Brompton Hospital, Guy's and St Thomas's NHS Foundation Trust
    London, SW3 6NP, United Kingdom
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06565832
Lead sponsor
Royal Brompton & Harefield NHS Foundation Trust
Collaborators
King's College London
Responsible party
Sponsor
First posted
Aug 22, 2024
Start date
May 1, 2023
Primary completion
Aug 1, 2023
Completion
Aug 1, 2023
Last update
Aug 22, 2024

Study contacts

Gemma E Stanford
principal investigator · Royal Brompton & Harefield NHS Foundation Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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