Respiratory Disease
Conditions
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.
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). 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.
Interventions
DIAGNOSTIC_TESTMaximal 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_TESTNormal 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'.
Sponsors
Hampshire Hospitals NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Caregiver)
Masking description
Results from the modified walk test will not be provided to the medical team prescribing ambulatory oxygen assessment.
Intervention model description
Perform test A followed by test B (randomised order)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Drop in SpO2 From Baseline to Nadir | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Is There a Difference in the Time Taken to Reach Nadir in SpO2? | During the walk test | The time from the start of the test and the lowest (nadir) SpO2 will be recorded and compared between the walk tests. |
| Is There a Difference in the Nadir SpO2 (%) Between Maximal and Normal Walking Speed? | During the walk test | The absolute lowest (nadir) in SpO2 (%) recorded during the test will be recorded and compared. |
Countries
United Kingdom
Contacts
PRINCIPAL_INVESTIGATORHarry Griffin, PhD
Hampshire Hospitals NHS Foundation Trust
PRINCIPAL_INVESTIGATORMichael J Hughes, PhD
Hampshire Hospitals NHS Foundation Trust
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 68.85 Years STANDARD_DEVIATION 10.98 |
| Primary Respiratory Diagnosis Asthma | 2 Participants |
| Primary Respiratory Diagnosis COPD | 12 Participants |
| Primary Respiratory Diagnosis ILD | 22 Participants |
| Primary Respiratory Diagnosis Other | 10 Participants |
| Primary Respiratory Diagnosis SOBOE | 2 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment United Kingdom | 37 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 82 | 0 / 82 |
| other Total, other adverse events | 0 / 82 | 0 / 82 |
| serious Total, serious adverse events | 0 / 82 | 0 / 82 |
Outcome results
None listed