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

NCT ID: NCT06565832

Last Updated: 2024-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2023-08-01

Brief Summary

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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

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

One-Minute Sit-to-Stand Test

Intervention Type 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

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

One-Minute Sit-to-Stand Test

Intervention Type 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

Intervention Type 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.

Interventions

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One-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.

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King's College London

OTHER

Sponsor Role collaborator

Royal Brompton & Harefield NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gemma E Stanford

Role: PRINCIPAL_INVESTIGATOR

Royal Brompton & Harefield NHS Foundation Trust

Locations

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

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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RExA-CF V3

Identifier Type: -

Identifier Source: org_study_id

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