Clinical trial NCT05630092: Comparing 6-Minute Walk Tests for Ambulatory Oxygen Assessment
Official title: Comparison of the Standard 6-Minute Maximal Speed Walk Test Against a 6-Minute Normal Speed Walk Test as an Alternative and More Accurate Assessment for Ambulatory Oxygen Requirement.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Disease
Lead sponsor: Hampshire Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2022-11-29
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Perform test A followed by test B (randomised order)
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Patients with lung disease who report breathlessness on exertion are often referred for a 6MWT. 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.

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: Patients with lung disease who report breathlessness on exertion are often referred for a 6MWT. During this test patients are asked to walk up and down a corridor (or other flat area) for six minutes whilst their blood oxygen levels and heart rate are non-invasively measured using a pulse oximeter (finger probe) and the distance walked is measured. In addition, a questionnaire that obtains a Borg Score measures the patients perceived breathlessness and leg muscle fatigue both before and immediately following the test.

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.

Eligibility criteria: Inclusion Criteria:

* Referred for a standard 6-minute walk test
* Has the capacity to give informed consent
* Is aged between 18 and 90

Exclusion Criteria:

* Lack of capacity to provide informed consent
* Poor peripheral perfusion that prevents an accurate measurement of SpO2
* Contraindicated to perform a Max_6MWT as indicated in the standard HHFT 6MWT SO

Primary outcomes:
measure: Average drop in SpO2 from baseline to nadir
timeFrame: During the walk test
Secondary outcomes:
measure: Is there a difference in the time taken to reach nadir in SpO2?
timeFrame: During the walk test
measure: Is there a difference in the absolute nadir SpO2 between maximal and normal walking.speed?
timeFrame: During the walk test
Other outcomes:
measure: At what time does the nadir in SpO2 occur during a Nor_6MWT
timeFrame: During the walk test
Locations:
city: Basingstoke
country: United Kingdom
facility: Hampshire Hospitals NHS Foundation Trust
Study officials:
affiliation: Hampshire Hospitals NHS Foundation Trust
name: Harry Griffin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hampshire Hospitals NHS Foundation Trust
name: Michael J Hughes, PhD
role: PRINCIPAL_INVESTIGATOR
References: