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Comparing 6-Minute Walk Tests for Ambulatory Oxygen Assessment

Not Applicable
Completed
Conditions
Respiratory Disease
Interventions
Diagnostic Test: Maximal 6-minute Walk Test (Max_6MWT)
Diagnostic Test: Normal speed 6-minute Walk Test (Nor_6MWT)
Registration Number
NCT05630092
Lead Sponsor
Hampshire Hospitals NHS Foundation Trust
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
93
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
Normal then Maximal Speed Walk TestMaximal 6-minute Walk Test (Max_6MWT)Normal speed walking test (Nor_6MWT) followed by Maximal speed walking test (Max_6MWT)
Maximal then Normal Speed Walk TestMaximal 6-minute Walk Test (Max_6MWT)Maximal speed walking test (Max_6MWT) followed by normal speed walking test (Nor_6MWT).
Maximal then Normal Speed Walk TestNormal speed 6-minute Walk Test (Nor_6MWT)Maximal speed walking test (Max_6MWT) followed by normal speed walking test (Nor_6MWT).
Normal then Maximal Speed Walk TestNormal speed 6-minute Walk Test (Nor_6MWT)Normal speed walking test (Nor_6MWT) followed by Maximal speed walking test (Max_6MWT)
Primary Outcome Measures
NameTimeMethod
Average drop in SpO2 from baseline to nadirDuring the walk test

Continuous monitoring of SpO2 will allow for the measurement in the drop from baseline to the lowest point (nadir) during the test. Between the walk tests, the average drop will be calculated and compared.

Secondary Outcome Measures
NameTimeMethod
Is there a difference in the absolute nadir SpO2 between maximal and normal walking.speed?During the walk test

The absolute lowest (nadir) SpO2 value will be recorded during each test and compared.

Is there a difference in the time taken to reach nadir in SpO2?During the walk test

The time from the start of the test and the lowest (nadir) SpO2 will be recorded and compared between the walk tests.

Trial Locations

Locations (1)

Hampshire Hospitals NHS Foundation Trust

🇬🇧

Basingstoke, United Kingdom

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