Comparing 6-Minute Walk Tests for Ambulatory Oxygen Assessment
Primary Purpose
Respiratory Disease
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Maximal 6-minute Walk Test (Max_6MWT)
Normal speed 6-minute Walk Test (Nor_6MWT)
Sponsored by
About this trial
This is an interventional health services research trial for Respiratory Disease
Eligibility Criteria
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
Sites / Locations
- Hampshire Hospitals NHS Foundation TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Maximal then Normal Speed Walk Test
Normal then Maximal Speed Walk Test
Arm Description
Maximal speed walking test (Max_6MWT) followed by normal speed walking test (Nor_6MWT).
Normal speed walking test (Nor_6MWT) followed by Maximal speed walking test (Max_6MWT)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Is there a difference in the absolute nadir SpO2 between maximal and normal walking.speed?
The absolute lowest (nadir) SpO2 value will be recorded during each test and compared.
Full Information
NCT ID
NCT05630092
First Posted
September 9, 2022
Last Updated
January 30, 2023
Sponsor
Hampshire Hospitals NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT05630092
Brief Title
Comparing 6-Minute Walk Tests for Ambulatory Oxygen Assessment
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hampshire Hospitals NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Disease
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Perform test A followed by test B (randomised order)
Masking
Care Provider
Masking Description
Results from the modified walk test will not be provided to the medical team prescribing ambulatory oxygen assessment.
Allocation
Randomized
Enrollment
82 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Maximal then Normal Speed Walk Test
Arm Type
Active Comparator
Arm Description
Maximal speed walking test (Max_6MWT) followed by normal speed walking test (Nor_6MWT).
Arm Title
Normal then Maximal Speed Walk Test
Arm Type
Active Comparator
Arm Description
Normal speed walking test (Nor_6MWT) followed by Maximal speed walking test (Max_6MWT)
Intervention Type
Diagnostic Test
Intervention Name(s)
Maximal 6-minute Walk Test (Max_6MWT)
Intervention Description
Instructions given to perform the walk test following the international guidelines using the phrase 'as far as you can'.
Intervention Type
Diagnostic Test
Intervention Name(s)
Normal speed 6-minute Walk Test (Nor_6MWT)
Intervention Description
Instructions given to perform the walk test following the international guidelines except using the phrase 'at a speed you would normally walk'.
Primary Outcome Measure Information:
Title
Average drop in SpO2 from baseline to nadir
Description
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.
Time Frame
During the walk test
Secondary Outcome Measure Information:
Title
Is there a difference in the time taken to reach nadir in SpO2?
Description
The time from the start of the test and the lowest (nadir) SpO2 will be recorded and compared between the walk tests.
Time Frame
During the walk test
Title
Is there a difference in the absolute nadir SpO2 between maximal and normal walking.speed?
Description
The absolute lowest (nadir) SpO2 value will be recorded during each test and compared.
Time Frame
During the walk test
Other Pre-specified Outcome Measures:
Title
At what time does the nadir in SpO2 occur during a Nor_6MWT
Description
Measurement of the time taken to reach nadir in SpO2 will be recorded to help justify the length of the walk test
Time Frame
During the walk test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Siobhan Laws
Phone
09162825345
Email
siobhan.laws@hhft.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harry Griffin, PhD
Organizational Affiliation
Hampshire Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael J Hughes, PhD
Organizational Affiliation
Hampshire Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hampshire Hospitals NHS Foundation Trust
City
Basingstoke
ZIP/Postal Code
RG24 9NA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harry Griffin, PhD
Email
harry.griffin@hhft.nhs.uk
First Name & Middle Initial & Last Name & Degree
Michael Hughes, PhD
Email
michael.hughes@hhft.nhs.uk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparing 6-Minute Walk Tests for Ambulatory Oxygen Assessment
We'll reach out to this number within 24 hrs