Comparing 6-Minute Walk Tests for Ambulatory Oxygen Assessment

National Health Service (NHS)

Status: Completed

Conditions: Respiratory Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05630092

2022 SPON-HG-0922

306758 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 93 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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93 participants in 2 patient groups

Maximal then Normal Speed Walk Test

Active Comparator group

Description:

Maximal speed walking test (Max_6MWT) followed by normal speed walking test (Nor_6MWT).

Treatment:

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 group

Description:

Normal speed walking test (Nor_6MWT) followed by Maximal speed walking test (Max_6MWT)

Treatment:

Diagnostic Test: Maximal 6-minute Walk Test (Max_6MWT)

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