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| ID | Type | Description | Link |
|---|---|---|---|
| 306758 | Registry Identifier | IRAS Project ID |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maximal then Normal Speed Walk Test | Active Comparator | Maximal speed walking test (Max_6MWT) followed by normal speed walking 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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'. |
|
| 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 |
| 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 Nadir SpO2 (%) Between Maximal and Normal Walking Speed? |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harry Griffin, PhD | Hampshire Hospitals NHS Foundation Trust | Principal Investigator |
| Michael J Hughes, PhD | Hampshire Hospitals NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hampshire Hospitals NHS Foundation Trust | Basingstoke | RG24 9NA | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Maximal Then Normal Speed Walk Test | Maximal speed walking test (Max_6MWT) followed by normal speed walking test (Nor_6MWT). 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'. 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'. |
| FG001 | Normal Then Maximal Speed Walk Test | Normal speed walking test (Nor_6MWT) followed by Maximal speed walking test (Max_6MWT) 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'. 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'. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 (M-N) | Maximal speed walking test (Max_6MWT) followed by normal speed walking test (Nor_6MWT). 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'. 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'. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants that successfully completed both tests were used in the final analysis, comparing the changes over each test type. | Posted | Median | Inter-Quartile Range | SpO2 (%) | During the walk test |
|
During study visit only whilst participants were attending for the study visit (1h) - there were no identified risks after the testing was complete.
Due to the nature of the trial/intervention, risks were very minimal and there was no requirement to follow patients after the study visit concluded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Max_6MWT | 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'. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deputy Lead Respiratory and Sleep Physiologist | Hampshire Hospitals NHS Foundation Trust | 01962824101 | michael.hughes@hhft.nhs.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2023 | Feb 11, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000070857 | Walk Test |
| ID | Term |
|---|---|
| D005080 | Exercise Test |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
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Perform test A followed by test B (randomised order)
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Results from the modified walk test will not be provided to the medical team prescribing ambulatory oxygen assessment.
| 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'. |
|
The absolute lowest (nadir) in SpO2 (%) recorded during the test will be recorded and compared. |
| During the walk test |
| BG001 | Group 2 (N-M) | Normal speed walking test (Nor_6MWT) followed by Maximal speed walking test (Max_6MWT) 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'. 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'. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Primary Respiratory Diagnosis | Count of Participants | Participants |
|
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'.
|
|
|
| Secondary | 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. | All participants that successfully completed both tests were used in the final analysis, comparing the changes over each test type. | Posted | Median | 95% Confidence Interval | Seconds | During the walk test |
|
|
|
|
| Secondary | 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. | All participants that successfully completed both tests were used in the final analysis, comparing the changes over each test type. | Posted | Mean | 95% Confidence Interval | SpO2 (%) | During the walk test |
|
|
|
|
| Other Pre-specified | 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 | All participants that successfully completed both tests were used in the final analysis, comparing the changes over each test type. | Posted | Median | Inter-Quartile Range | Seconds | During the walk test |
|
|
|
|
| 0 |
| 82 |
| 0 |
| 82 |
| 0 |
| 82 |
| EG001 | Nor_6MWT | 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'. | 0 | 82 | 0 | 82 | 0 | 82 |
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| D003933 | Diagnosis |
| ILD |
|
| SOBOE |
|
| Other |
|