Comparing 6-Minute Walk Tests for Ambulatory Oxygen Assessment

NCT ID: NCT05630092

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-05-01

Brief Summary

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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

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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.

Conditions

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Respiratory Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Perform test A followed by test B (randomised order)
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Caregivers
Results from the modified walk test will not be provided to the medical team prescribing ambulatory oxygen assessment.

Study Groups

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Maximal then Normal Speed Walk Test

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

Group Type ACTIVE_COMPARATOR

Maximal 6-minute Walk Test (Max_6MWT)

Intervention Type 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)

Intervention Type DIAGNOSTIC_TEST

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

Normal then Maximal Speed Walk Test

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

Group Type ACTIVE_COMPARATOR

Maximal 6-minute Walk Test (Max_6MWT)

Intervention Type 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)

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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'.

Intervention Type 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'.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hampshire Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harry Griffin, PhD

Role: PRINCIPAL_INVESTIGATOR

Hampshire Hospitals NHS Foundation Trust

Michael J Hughes, PhD

Role: PRINCIPAL_INVESTIGATOR

Hampshire Hospitals NHS Foundation Trust

Locations

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Hampshire Hospitals NHS Foundation Trust

Basingstoke, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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306758

Identifier Type: REGISTRY

Identifier Source: secondary_id

2022 SPON-HG-0922

Identifier Type: -

Identifier Source: org_study_id