Trial Outcomes & Findings for Comparing 6-Minute Walk Tests for Ambulatory Oxygen Assessment (NCT NCT05630092)
NCT ID: NCT05630092
Last Updated: 2026-04-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
93 participants
Primary outcome timeframe
During the walk test
Results posted on
2026-04-20
Participant Flow
Participant milestones
| Measure |
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'.
|
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'.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
45
|
|
Overall Study
COMPLETED
|
45
|
37
|
|
Overall Study
NOT COMPLETED
|
3
|
8
|
Reasons for withdrawal
| Measure |
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'.
|
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'.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
8
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1 (M-N)
n=45 Participants
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'.
|
Group 2 (N-M)
n=37 Participants
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'.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.36 Years
STANDARD_DEVIATION 11.09 • n=45 Participants
|
68.24 Years
STANDARD_DEVIATION 10.97 • n=37 Participants
|
68.85 Years
STANDARD_DEVIATION 10.98 • n=82 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=45 Participants
|
10 Participants
n=37 Participants
|
27 Participants
n=82 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=45 Participants
|
27 Participants
n=37 Participants
|
55 Participants
n=82 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
45 participants
n=45 Participants
|
37 participants
n=37 Participants
|
82 participants
n=82 Participants
|
|
Primary Respiratory Diagnosis
Asthma
|
1 Participants
n=45 Participants
|
1 Participants
n=37 Participants
|
2 Participants
n=82 Participants
|
|
Primary Respiratory Diagnosis
COPD
|
16 Participants
n=45 Participants
|
12 Participants
n=37 Participants
|
28 Participants
n=82 Participants
|
|
Primary Respiratory Diagnosis
ILD
|
22 Participants
n=45 Participants
|
15 Participants
n=37 Participants
|
37 Participants
n=82 Participants
|
|
Primary Respiratory Diagnosis
SOBOE
|
3 Participants
n=45 Participants
|
2 Participants
n=37 Participants
|
5 Participants
n=82 Participants
|
|
Primary Respiratory Diagnosis
Other
|
3 Participants
n=45 Participants
|
7 Participants
n=37 Participants
|
10 Participants
n=82 Participants
|
PRIMARY outcome
Timeframe: During the walk testPopulation: All participants that successfully completed both tests were used in the final analysis, comparing the changes over each test type.
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.
Outcome measures
| Measure |
Max_6MWT
n=82 Participants
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'.
|
Nor_6MWT
n=82 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'.
|
|---|---|---|
|
Average Drop in SpO2 From Baseline to Nadir
|
6 SpO2 (%)
Interval 5.0 to 7.0
|
5 SpO2 (%)
Interval 4.0 to 6.0
|
SECONDARY outcome
Timeframe: During the walk testPopulation: All participants that successfully completed both tests were used in the final analysis, comparing the changes over each test type.
The time from the start of the test and the lowest (nadir) SpO2 will be recorded and compared between the walk tests.
Outcome measures
| Measure |
Max_6MWT
n=82 Participants
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'.
|
Nor_6MWT
n=82 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'.
|
|---|---|---|
|
Is There a Difference in the Time Taken to Reach Nadir in SpO2?
|
150 Seconds
Interval 120.0 to 170.0
|
150 Seconds
Interval 140.0 to 160.0
|
SECONDARY outcome
Timeframe: During the walk testPopulation: All participants that successfully completed both tests were used in the final analysis, comparing the changes over each test type.
The absolute lowest (nadir) in SpO2 (%) recorded during the test will be recorded and compared.
Outcome measures
| Measure |
Max_6MWT
n=82 Participants
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'.
|
Nor_6MWT
n=82 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'.
|
|---|---|---|
|
Is There a Difference in the Nadir SpO2 (%) Between Maximal and Normal Walking Speed?
|
88.41 SpO2 (%)
95% Confidence Interval 4.883 • Interval 87.34 to 89.43
|
88.98 SpO2 (%)
95% Confidence Interval 4.385 • Interval 88.01 to 89.94
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During the walk testPopulation: All participants that successfully completed both tests were used in the final analysis, comparing the changes over each test type.
Measurement of the time taken to reach nadir in SpO2 will be recorded to help justify the length of the walk test
Outcome measures
| Measure |
Max_6MWT
n=82 Participants
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'.
|
Nor_6MWT
n=82 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'.
|
|---|---|---|
|
At What Time Does the Nadir in SpO2 Occur During a Nor_6MWT
|
150 Seconds
Interval 90.0 to 210.0
|
150 Seconds
Interval 90.0 to 210.0
|
Adverse Events
Max_6MWT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nor_6MWT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Deputy Lead Respiratory and Sleep Physiologist
Hampshire Hospitals NHS Foundation Trust
Phone: 01962824101
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place