Comparing 6-Minute Walk Tests for Ambulatory Oxygen Assessment

NCT05630092 | Completed Results

• 2 other identifiers: 2022 SPON-HG-0922306758
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  During the walk test

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

  During the walk test

Other Outcomes (1)

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

  During the walk test

Study Arms (2)

Maximal then Normal Speed Walk Test

ACTIVE COMPARATOR

Maximal speed walking test (Max\_6MWT) followed by normal speed walking test (Nor\_6MWT).

Diagnostic Test: Maximal 6-minute Walk Test (Max_6MWT); Diagnostic Test: Normal speed 6-minute Walk Test (Nor_6MWT)

Normal then Maximal Speed Walk Test

ACTIVE COMPARATOR

Normal speed walking test (Nor\_6MWT) followed by Maximal speed walking test (Max\_6MWT)

Diagnostic Test: Maximal 6-minute Walk Test (Max_6MWT); Diagnostic Test: Normal speed 6-minute Walk Test (Nor_6MWT)

Interventions

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'.

Maximal then Normal Speed Walk Test; Normal then Maximal Speed Walk Test

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'.

Maximal then Normal Speed Walk Test; Normal then Maximal Speed Walk Test

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hampshire Hospitals NHS Foundation Trust: lead

Study Sites (1)

Hampshire Hospitals NHS Foundation Trust

Basingstoke, RG24 9NA, United Kingdom

Location

MeSH Terms

Conditions

Respiration Disorders

Interventions

Walk Test

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Exercise Test; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis

Limitations and Caveats

As the study design was a crossover randomised trial, there is potential for fatigue from the first walk test to impact on the assessment of the next walk test. Adequate rest time was factored into the trial design and the randomised approach helped mitigate this factor, including the known learning effect associated with repeat 6MWT.

Results Point of Contact

• Title: Deputy Lead Respiratory and Sleep Physiologist
• Organization: Hampshire Hospitals NHS Foundation Trust

michael.hughes@hhft.nhs.uk

01962824101

Study Officials

• Harry Griffin, PhD

  Hampshire Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Michael J Hughes, PhD

  Hampshire Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Results from the modified walk test will not be provided to the medical team prescribing ambulatory oxygen assessment.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Perform test A followed by test B (randomised order)

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: November 29, 2022
• Study Start: January 1, 2023
• Primary Completion: February 23, 2024
• Study Completion: May 1, 2024
• Last Updated: April 20, 2026
• Results First Posted: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)