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Trial registered on ANZCTR


Registration number
ACTRN12620000345987
Ethics application status
Approved
Date submitted
3/03/2020
Date registered
11/03/2020
Date last updated
13/07/2021
Date data sharing statement initially provided
11/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A clinical comparison of the six minute walk test to a six minute step test protocol for prescribing ambulatory oxygen.
Scientific title
A clinical comparison of the six minute walk test to a six minute step test protocol for prescribing ambulatory oxygen.
Secondary ID [1] 300691 0
Nil known
Universal Trial Number (UTN)
U1111-1249-0921
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oxygen prescription 316503 0
Condition category
Condition code
Respiratory 314748 314748 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief Name: Ambulatory Oxygen assessments: the Six Minute Walk Test (6MWT) (Arm 1) and a Step Test protocol (Arm 2).

What:
Arm 1 - Materials for the 6MWT: 30 meter flat walking track (with marks every 1m), two seats, marker cones, High-Vis vests (for patient and tester), cylinder oxygen (c-size, in cylinder trolley as approved by the hospital biomedical engineering department), Oxygen Conserving Device (OCD) set at pulse 4, nasal cannula, stop watch, Oximeter, Modified Borg Scale (10 point) for rating perception of breathlessness and leg fatigue, scripted test instructions (international standards ATS 2005 and 2014 update).
Arm 2 - Materials for the Step Test: 2-level step apparatus with hand rails (1 meter squared footprint), seat, oxygen delivery cart comprising of a c-size oxygen cylinder and c-size medical air cylinder attached to an oxygen titration device (set at 4 pulsed), nasal cannula, stop watch, Oximeter, Modified Borg Scale (10 point) for rating perception of breathlessness and leg fatigue.
Materials for patient: Patient Information Sheet (approved by local HREC), patient consent form (approved by local HREC), patient “Questionnaire” (approved by local HREC).
Who provided: Pulmonary Function (PFT) Laboratory staff (ie. the Clinical Medical Scientists) working in the Queen Elizabeth Hospital (TQEH) PFT Lab conduct the patient testing, recruit the patients, and record the patient data as per routine clinical testing protocol for TQEH PFT Laboratory. Each lab staff has a minimum of 3 years undergraduate tertiary education in a relevant science applicable to respiratory medicine, and a minimum of 2 years employment in the TQEH PFT lab.

How: All testing is conducted face-to-face with the Medical Scientist and patient, in an individual one-on-one testing context.
Arm 1 - 6MWT protocol:
1. The patient is seated for 10 minutes at the 30m-track start line, with the pulse oximeter attached. Oxygen saturations (SpO2), Borg Scale ratings for breathlessness and leg fatigue (resting values, “pre-exercise”) are recorded.
2. Test instructions are given (as per ATS 2005 and 2014-update guidelines). Patient instructed to stand, and stop watch set to 0:00.
3. Patient instructed to begin walking. Test instruction instructions are given at each minute mark (as per ATS 2005 and 2014 guidelines).
4. End of Test: At 6 minutes patient instructed to stop, SpO2 and Borg Scale ratings for breathlessness and leg fatigue (peak exercise values, “post-exercise”) are recorded. (NOTE: patient may stop walking and restart during the 6 minutes exercise period, as many times as they like and for any time duration. Number of stops are recorded.)
5. Patient instructed to sit, resting for 10 minutes minimum (at the 30m-track start line) connected to supplemental oxygen cylinder (nasal cannula, OCD at pulse setting 4).
6. Walk test repeated as above (steps 1-4), with supplemental oxygen (delivered via nasal cannula with OCD on pulse setting 4) in place also, while walking.
(Walking aides are permitted as per the patient’s capacity/choice. Specific aides must be recorded and must be used in both repeats of the 6MWT.)

Arm 2 - Step Test protocol:
1. The patient is seated for 10 minutes in front of the Step setup, with the pulse oximeter attached and connected to medical air cylinder (nasal cannula, OCD at pulse setting 4). Oxygen saturations (SpO2), Borg Scale ratings for breathlessness and leg fatigue (resting values, “pre-exercise”) are recorded.
2. Test instructions are given (as per TQEH Laboratory Procedures Manual). Patient instructed to stand, and stop watch set to 0:00.
3. Patient instructed to begin stepping.
4. End of Test: At 6 minutes or as soon as the patient wishes to stop/pause stepping (ie. before 6 minutes has passed), the patient is instructed to be seated. Stop time, SpO2 and Borg Scale ratings for breathlessness and leg fatigue (peak exercise values, “post-exercise”) are recorded. Recovery time for SpO2 is recorded (ie. minutes/seconds taken for SpO2 to return to pre-test SpO2 %).
5. Patient instructed to remain seated, resting for 10 minutes minimum (in front of the Step setup) connected to supplemental oxygen cylinder (nasal cannula, OCD at pulse setting 4).
6. Step test repeated as above (steps 1-4), with supplemental oxygen (delivered via nasal cannula with OCD on pulse setting 4) in place also, while stepping and during the recovery (resting) time after stepping has ceased.

Where: All testing is conducted within the Pulmonary Function Laboratory at TQEH, on the designated 6MW track (30 meters) and in the designated Exercise Laboratory room (where the stepping apparatus and Oxygen delivery cart are permanently set up). See methods for 6MWT and Step Test for infrastructure outline.

When and How much: The 6MWT is conducted as per International Standards (ATS 2005 and 2014 update) on room air (ie no cylinder gases), and then repeated with cylinder oxygen (as described below). There is a 10-30 minutes resting period between repeats. The Step Test is conducted on the placebo gas (cylinder medical air), and repeated on cylinder oxygen, also with a 10-30 minutes resting period between repeats.
The 2 ambulatory oxygen assessment tests (6MWT and Step Test) are conducted as either two 30 minute sessions with a week in between (1 session for the 6MWTs and 1 session for the Step Test), or in one longer session (of 60-90 minutes, where both test protocols are performed (as above) on the same day with a minimum of 30 minutes between the 6MWTs and Step Test), as the patient prefers. In both tests, the oxygen is delivered via nasal cannula with a pulsed flow rate set on 4. In the step test, the medical air (placebo) is also delivered via nasal cannula with pulsed flow rate set on 4.
Intervention code [1] 317016 0
Early detection / Screening
Comparator / control treatment
The patients are their own controls.

Placebo for both tests
Arm 1 - Six Minute Walk Test: the first test is conducted without any supplemental oxygen/gases (ie. on "Room Air")
Arm 2 - Step Test: the : the first test is conducted on Medical air

Treatment for both tests
Arm 1 - Six Minute Walk Test: the second test is conducted on supplemental oxygen
Arm 2 - Step Test: the : the first test is conducted on supplemental oxygen

All gases are delivered by cylinder connected to patient via nasal cannula, on a pulsed setting of 4 (an oxygen conserving device connected to the gas cylinders controls the pulse flow rates).
Control group
Active

Outcomes
Primary outcome [1] 323110 0
Functional capacity (steps and/or meters walked) as assessed by the Step Test and 6MWT
Timepoint [1] 323110 0
end of test (EOT) criteria.
Secondary outcome [1] 380842 0
SpO2 as assessed by a Pulse Oximeter during both the Step Test and 6MWT.
Timepoint [1] 380842 0
EOT criteria.

Eligibility
Key inclusion criteria
Participants
Participants will be recruited from test referrals sent to the TQEH PFT laboratory for either a 6MWT or a step test (our TQEH laboratory protocol), with the clinical purpose of determining if the patient will benefit from supplemental oxygen while on exertion (or for “home oxygen”). Patients referred for testing for such clinical reasons are referred because they do not meet the national cut of PaO2 less than 55mmHg (as per a recent Arterial Blood Gas (ABG) test) and they do not automatically qualify for oxygen.

Inclusion criteria:
Patient must have had a recent ABG taken in the days leading up to the appointment (not > 4 weeks before). They must be symptomatically breathless when performing sedentary tasks, such as walking short distances, showering, making the bed, grocery shopping, etc. The patient must have seen a physician regarding the symptoms, and have been assessed as a possible candidate for oxygen therapy.
> PaO2 greater than 55mmHg
> SOB with low-level exercise
> Test referral for either the step test or 6MWT received at TQEH PFT laboratory with clinical questions noted on the referral as: “?benefit of oxygen”, “?home oxygen” or “?desaturation on exercise” (or similar words expressing the same clinical question).
> Able to complete both 6MWT and step test as per the current laboratory protocols
> Able to comprehend the Borg Scale for perception values
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
Patient must not already be on exertional oxygen nor have a current oxygen prescription. They must also not have or be:
> PaO2 less than 55mmHg
> SpO2 less than 85% at rest
> Current smoker
> Sent for a 6MWT for reasons other than assessment for oxygen (ie. PAH, medication schemes, pulmonary rehabilitation assessment, etc.)
> Unable to complete step test requirements during testing
> Poor comprehension of test instructions
> Poor comprehension of the Borg Scale for perception values
> Poor SpO2 oximeter values
> Wheelchair or bed bound
> Unable to trigger the pulsed Oxygen Conserving Device (OCD) used in the step test
> Refusal to complete both or one of the tests
> Lab staff or medical staff terminate both or one of the tests early
> Adverse events which may include trips, falls, loss of consciousness and arousal of respiratory events

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Allocation is by physician referral to laboratory (test specific, ie. the 6MWT or the Step Test) for the first test.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
"Non-randomized" because patient is identified as a potential subject for the Trail, after the laboratory has received a Physicians clinical Test Request form, requesting a specific test (ie. the 6MWT or the Step Test). Patients are approached for recruitment at this test appointment, and Subject consent includes the use of this first (clinically requested) test. Hence, tests are not randomized in the traditional sense.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Blinding is only possible in the Step Test: the first cylinder used (medical air) is identical to the oxygen cylinder used, hence the subject (if this is Arm 2) /patient (if this is Arm 1) is not aware of which gas they are receiving.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Correlation of functional parameters (meters and steps).

P-values of the changes in saturations while on Placebo between Arm 1 and Arm 2 (ie. 6MWT and Step Test)

P-values of the changes in saturations while on treatment between Arm 1 and Arm 2 (ie. 6MWT and Step Test)

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
31/07/2019
Date of last participant enrolment
Anticipated
1/12/2020
Actual
30/06/2020
Date of last data collection
Anticipated
30/12/2020
Actual
14/07/2020
Sample size
Target
32
Accrual to date
Final
61
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 16055 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 29566 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 305135 0
Government body
Name [1] 305135 0
SAHealth
Country [1] 305135 0
Australia
Primary sponsor type
Hospital
Name
The Queen Elizabeth Hospital
Address
Central Adelaide Local Health Network (CALHN)
The Queen Elizabeth Hospital (TQEH)
28 Woodville Rd,
Woodville South, South Australia 5011
Country
Australia
Secondary sponsor category [1] 305495 0
None
Name [1] 305495 0
Address [1] 305495 0
Country [1] 305495 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305505 0
CALHN Human Ethics Research Committee
Ethics committee address [1] 305505 0
Ethics committee country [1] 305505 0
Australia
Date submitted for ethics approval [1] 305505 0
11/04/2019
Approval date [1] 305505 0
29/07/2019
Ethics approval number [1] 305505 0
11842
Ethics committee name [2] 305515 0
Charles Sturt University HREC
Ethics committee address [2] 305515 0
Ethics committee country [2] 305515 0
Australia
Date submitted for ethics approval [2] 305515 0
29/04/2019
Approval date [2] 305515 0
10/05/2019
Ethics approval number [2] 305515 0
H19137

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100598 0
Miss Donna Keatley
Address 100598 0
The Queen Elizabeth Hospital
Pulmonary Function Laboratory, Level 4A,
28 Woodville Rd, Woodville South,
South Australia 5011
Country 100598 0
Australia
Phone 100598 0
+61 8 82226474
Fax 100598 0
+61 8 82226041
Email 100598 0
donna.keatley@sa.gov.au
Contact person for public queries
Name 100599 0
Donna Keatley
Address 100599 0
The Queen Elizabeth Hospital
Pulmonary Function Laboratory, Level 4A,
28 Woodville Rd, Woodville South,
South Australia 5011
Country 100599 0
Australia
Phone 100599 0
+61 8 82226474
Fax 100599 0
+61 8 82226041
Email 100599 0
donna.keatley@sa.gov.au
Contact person for scientific queries
Name 100600 0
Donna Keatley
Address 100600 0
The Queen Elizabeth Hospital
Pulmonary Function Laboratory, Level 4A,
28 Woodville Rd, Woodville South,
South Australia 5011
Country 100600 0
Australia
Phone 100600 0
+61 8 82226474
Fax 100600 0
+61 8 82226041
Email 100600 0
donna.keatley@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
In Arm 1, the first test (patient data) is restrained under SAHealth Patient Confidentiality regulations, as the first test is a routine physician referral for clinical testing. In Arm 2, the second test (after recruitment and consent) is conducted as per the Department clinical procedures but specifically for research purposes. Hence the research data set (Arm 1 and Arm 2) need to be available together to make sense of this trial.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7221Clinical study report    Will be provided when Study report is produced at ... [More Details]



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