Respiratory DiseaseNCT05630092

Comparing 6-Minute Walk Tests for Ambulatory Oxygen Assessment

A study testing Maximal 6-minute Walk Test (Max_6MWT) and Normal speed 6-minute Walk Test (Nor_6MWT) in people with Respiratory Disease, run by Hampshire Hospitals NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Respiratory Disease
What is being tested?: Maximal 6-minute Walk Test (Max_6MWT) and Normal speed 6-minute Walk Test (Nor_6MWT)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 93 participants
Where: 1 siteUnited Kingdom
Study dates: 1 Jan 2023to 1 May 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United Kingdom1 site

Hampshire Hospitals NHS Foundation Trust
Basingstoke, RG24 9NA

Other trials in United Kingdom

About this study

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.

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.

Read the 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).

Conditions: Respiratory Disease
Being tested: Maximal 6-minute Walk Test (Max_6MWT), Normal speed 6-minute Walk Test (Nor_6MWT)
Medical subject headings: Respiration Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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'.
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'.

Study groups in NCT05630092
Study group	Role	What they receive
Maximal then Normal Speed Walk Test	Active comparator	Maximal speed walking test (Max_6MWT) followed by normal speed walking test (Nor_6MWT). Receives: 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) Receives: Diagnostic Test: Maximal 6-minute Walk Test (Max_6MWT); Diagnostic Test: Normal speed 6-minute Walk Test (Nor_6MWT)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: During the walk test

Secondary outcomes (2)

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.
Measured: During the walk test
Is There a Difference in the Nadir SpO2 (%) Between Maximal and Normal Walking Speed?
The absolute lowest (nadir) in SpO2 (%) recorded during the test will be recorded and compared.
Measured: During the walk test

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20231 May 2024

First posted29 Nov 2022
Study start1 Jan 2023
Primary completion23 Feb 2024
Study completion1 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Respiratory DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Crossover
Model description: Perform test A followed by test B (randomised order)
Masking: Single blind
Who is masked: Care provider
Enrolment: 93 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05630092
Sponsor's protocol ID: 2022 SPON-HG-0922
Other IDs: 306758
Status last verified: Apr 2026
First submitted: 9 Sep 2022
Last updated: 20 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT05630092
Acronym / sponsor ID: 2022 SPON-HG-0922
Conditions: Respiratory Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 93 participants (actual)
Lead sponsor: Hampshire Hospitals NHS Foundation TrustUniversity, hospital or other
Study start: 1 Jan 2023 (actual)
Primary completion: 23 Feb 2024 (actual)
Study completion: 1 May 2024 (actual)
First posted: 29 Nov 2022 (actual)
Results: Posted 20 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (care provider)
Number of arms: 2
Model description: Perform test A followed by test B (randomised order)

Arm	Type	Receives
Maximal then Normal Speed Walk Test	Active comparator	Diagnostic Test: Maximal 6-minute Walk Test (Max_6MWT), Diagnostic Test: Normal speed 6-minute Walk Test (Nor_6MWT)Maximal speed walking test (Max_6MWT) followed by normal speed walking test (Nor_6MWT).
Normal then Maximal Speed Walk Test	Active comparator	Diagnostic Test: Maximal 6-minute Walk Test (Max_6MWT), Diagnostic Test: Normal speed 6-minute Walk Test (Nor_6MWT)Normal speed walking test (Nor_6MWT) followed by Maximal speed walking test (Max_6MWT)

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Maximal then Normal Speed Walk Test, Normal then Maximal Speed Walk 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'.	Diagnostic test	Maximal then Normal Speed Walk Test, Normal then Maximal Speed Walk Test

Primary outcome

Average Drop in SpO2 From Baseline to Nadir
Time frame: During the walk test
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.

2 secondary outcomes

Is There a Difference in the Time Taken to Reach Nadir in SpO2?
Time frame: During the walk test
Is There a Difference in the Nadir SpO2 (%) Between Maximal and Normal Walking Speed?
Time frame: During the walk test

Results and safety

Results posted to the registry on 20 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Maximal Then Normal Speed Walk Test	48	45
Normal Then Maximal Speed Walk Test	45	37

Primary outcome: Average Drop in SpO2 From Baseline to Nadir

Time frame: During the walk test. Median (Inter-Quartile Range). Unit: SpO2 (%)

Measure	Max_6MWT n = 82	Nor_6MWT n = 82
Value	6 (5 to 7)	5 (4 to 6)

Max_6MWT vs Nor_6MWT: p <0.01, Wilcoxon (Mann-Whitney)

Population analysed: All participants that successfully completed both tests were used in the final analysis, comparing the changes over each test type.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: During study visit only whilst participants were attending for the study visit (1h) - there were no identified risks after the testing was complete.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Max_6MWT	0 of 82 (0%)	0 of 82 (0%)	0 of 82
Nor_6MWT	0 of 82 (0%)	0 of 82 (0%)	0 of 82

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
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Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Harry Griffin, PhD principal investigator

Hampshire Hospitals NHS Foundation Trust

Michael J Hughes, PhD principal investigator

Hampshire Hospitals NHS Foundation Trust

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Drop in SpO2 From Baseline to Nadir (time frame: During the walk test). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05630092.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.