Comparing 6-Minute Walk Tests for Ambulatory Oxygen Assessment

Respiratory Disease Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05630092
• Other study ID #: 2022 SPON-HG-0922
• Secondary ID: 306758
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: February 2024
• Source: Hampshire Hospitals NHS Foundation Trust
• Contact: Siobhan Laws
• Phone: 09162825345
• Email: siobhan.laws[@]hhft.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases

Intervention

Diagnostic Test:
• 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'.

Locations

Country	Name	City	State
United Kingdom	Hampshire Hospitals NHS Foundation Trust	Basingstoke

Sponsors (1)

Lead Sponsor	Collaborator
Hampshire Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	At what time does the nadir in SpO2 occur during a Nor_6MWT	Measurement of the time taken to reach nadir in SpO2 will be recorded to help justify the length of the walk test	During the walk test
Primary	Average drop in SpO2 from baseline to nadir	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.	During the walk test
Secondary	Is there a difference in the time taken to reach nadir in SpO2?	The time from the start of the test and the lowest (nadir) SpO2 will be recorded and compared between the walk tests.	During the walk test
Secondary	Is there a difference in the absolute nadir SpO2 between maximal and normal walking.speed?	The absolute lowest (nadir) SpO2 value will be recorded during each test and compared.	During the walk test