Comparing 6-Minute Walk Tests for Ambulatory Oxygen Assessment

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Disease
• Intervention / Treatment: Diagnostic test: Maximal 6-minute Walk Test (Max_6MWT); Diagnostic test: Normal speed 6-minute Walk Test (Nor_6MWT)

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.

• Study Type: Interventional
• Enrollment (Estimated): 82
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Siobhan Laws; Phone Number: 09162825345; Email: siobhan.laws@hhft.nhs.uk

Study Locations

• United Kingdom
  • Basingstoke, United Kingdom, RG24 9NA
    • Recruiting
    • Hampshire Hospitals NHS Foundation Trust
    • Contact: Harry Griffin, PhD; Email: harry.griffin@hhft.nhs.uk
    • Contact: Michael Hughes, PhD; Email: michael.hughes@hhft.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Maximal then Normal Speed Walk Test; Maximal speed walking test (Max_6MWT) followed by normal speed walking test (Nor_6MWT).	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'.; Diagnostic test: 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'.
Active Comparator: Normal then Maximal Speed Walk Test; Normal speed walking test (Nor_6MWT) followed by Maximal speed walking test (Max_6MWT)	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'.; Diagnostic test: 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'.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hampshire Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Harry Griffin, PhD, Hampshire Hospitals NHS Foundation Trust; Principal Investigator: Michael J Hughes, PhD, Hampshire Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): August 30, 2024
• Study Completion (Estimated): August 30, 2024

Study Registration Dates

• First Submitted: September 9, 2022
• First Submitted That Met QC Criteria: November 17, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: 2022 SPON-HG-0922; 306758 (Registry Identifier: IRAS Project ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No