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Completed

NCT Number: NCT05630092

Comparing 6-Minute Walk Tests for Ambulatory Oxygen Assessment

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hampshire Hospitals NHS Foundation Trust

Basingstoke, RG24 9NA, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Maximal 6-minute Walk Test (Max_6MWT)

Diagnostic Test

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)

Diagnostic Test

Instructions given to perform the walk test following the international guidelines except using the phrase 'at a speed you would normally walk'.

Primary outcomes

  1. Average Drop in SpO2 From Baseline to Nadir

    Time frame: During 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 outcomes

  1. Is There a Difference in the Time Taken to Reach Nadir in SpO2?

    Time frame: 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.

  2. Is There a Difference in the Nadir SpO2 (%) Between Maximal and Normal Walking Speed?

    Time frame: During the walk test

    The absolute lowest (nadir) in SpO2 (%) recorded during the test will be recorded and compared.

Other outcomes

  1. At What Time Does the Nadir in SpO2 Occur During a Nor_6MWT

    Time frame: During the walk test

    Measurement of the time taken to reach nadir in SpO2 will be recorded to help justify the length of the walk test

Sponsors and collaborators

Lead sponsor

Hampshire Hospitals NHS Foundation Trust

Other

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 29, 2022
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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