Comparing 6-Minute Walk Tests for Ambulatory Oxygen Assessment
NCT ID: NCT05630092
Last Updated: 2024-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
93 participants
INTERVENTIONAL
2023-01-01
2024-05-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
In this study, patients who are routinely referred for a Max-6MWT to investigate possible exercise-induced hypoxaemia will be invited to perform an additional walking test which is performed at their normal walking speed, referred here on in as a Nor\_6MWT. We hypothesise that performing a Nor\_6MWT will provide a more accurate assessment of a patients' oxygen requirement, primarily from their oxygen desaturation during the test.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Due to the nature of the 6MWT (hereon referred to as a Max-6MWT), patients are required to walk as far as they can in 6 minutes. This may lead to an inaccurate assessment of their requirement for ambulatory oxygen as this form of exercise may not correspond to their normal daily activities. It may also not accurately measure the normal changes in oxygen saturation (or desaturation) that occurs in these patients during their normal daily activities (such as walking to the shops, walking up the stairs, gardening).
In this study, patients who are routinely referred for a Max-6MWT to investigate possible exercise-induced hypoxaemia will be invited to perform an additional walking test which is performed at their normal walking speed, referred here on in as a Nor\_6MWT. We hypothesise that performing a Nor\_6MWT will provide a more accurate assessment of a patients' oxygen requirement, primarily from their oxygen desaturation during the test.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Maximal then Normal Speed Walk Test
Maximal speed walking test (Max\_6MWT) followed by normal speed walking test (Nor\_6MWT).
Maximal 6-minute Walk Test (Max_6MWT)
Instructions given to perform the walk test following the international guidelines using the phrase 'as far as you can'.
Normal speed 6-minute Walk Test (Nor_6MWT)
Instructions given to perform the walk test following the international guidelines except using the phrase 'at a speed you would normally walk'.
Normal then Maximal Speed Walk Test
Normal speed walking test (Nor\_6MWT) followed by Maximal speed walking test (Max\_6MWT)
Maximal 6-minute Walk Test (Max_6MWT)
Instructions given to perform the walk test following the international guidelines using the phrase 'as far as you can'.
Normal speed 6-minute Walk Test (Nor_6MWT)
Instructions given to perform the walk test following the international guidelines except using the phrase 'at a speed you would normally walk'.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Maximal 6-minute Walk Test (Max_6MWT)
Instructions given to perform the walk test following the international guidelines using the phrase 'as far as you can'.
Normal speed 6-minute Walk Test (Nor_6MWT)
Instructions given to perform the walk test following the international guidelines except using the phrase 'at a speed you would normally walk'.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Has the capacity to give informed consent
* Is aged between 18 and 90
Exclusion Criteria
* Poor peripheral perfusion that prevents an accurate measurement of SpO2
* Contraindicated to perform a Max\_6MWT as indicated in the standard HHFT 6MWT SO
18 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hampshire Hospitals NHS Foundation Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Harry Griffin, PhD
Role: PRINCIPAL_INVESTIGATOR
Hampshire Hospitals NHS Foundation Trust
Michael J Hughes, PhD
Role: PRINCIPAL_INVESTIGATOR
Hampshire Hospitals NHS Foundation Trust
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hampshire Hospitals NHS Foundation Trust
Basingstoke, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
306758
Identifier Type: REGISTRY
Identifier Source: secondary_id
2022 SPON-HG-0922
Identifier Type: -
Identifier Source: org_study_id