Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000091303
Ethics application status
Approved
Date submitted
13/01/2017
Date registered
17/01/2017
Date last updated
29/03/2021
Date data sharing statement initially provided
29/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Validation of the 2-minute step test in healthy middle-aged adults.
Scientific title
Sub-maximal assessment of aerobic capacity using the 2-minute step test in healthy middle-aged adults: a validation study.
Secondary ID [1] 290915 0
Nil
Universal Trial Number (UTN)
U1111-1191-6225
Trial acronym
Nil
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Aerobic capacity 301638 0
Condition category
Condition code
Public Health 301339 301339 0 0
Health promotion/education

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Design
This is a criterion validity study to be conducted at the University of Canberra. Following recruitment of eligible healthy middle-aged adults, the participants will be required to take part in a submaximal fitness test (2 minute step test (2-MST)) and a peak incremental cycle fitness test to assess peak oxygen consumption (VO2peak; criterion measure). Participants will be required to complete the fitness tests on one day, with an adequate rest (heart rate returned to resting level) in between tests to minimise fatigue. The 2-MST will be completed first, followed by the peak incremental cycle test on the same day.

2 minute step test
The 2-MST requires little space and equipment, with large studies finding it both reliable and valid in older adults. The 2-MST protocol involves determining the number of times in 2 minutes that a person can step in place raising the knees to a height halfway between the patella (kneecap) and iliac crest (front hip bone), a continuous measurement. Two trials will be administered (practice test followed by the official test) by a physiotherapist, allowing an adequate rest (heart rate returned to resting level) between tests to minimise fatigue. Outcome measure is the number of steps completed by the right leg in 2 minutes. Manual heart rate taken for 15 seconds will also be taken at the end of the 2-MST to calculate heart rate in beats per minute. To improve the validity of taking manual heart rate following the 2MST, a heart rate monitor will also be used, and these two measures will be compared to determine the accuracy of the manual heart rate.

Peak cycle fitness test (GXT)
Direct measurement of aerobic fitness (VO2peak) will be measured on a stationary bicycle by an exercise physiologist. An incremental test will be carried out where participants will begin cycling at an easy level and additional resistance will be applied each minute. The participants will be fitted with a facemask (V2 Mask, Hans-Rudolph, Inc., United States of America) to enable the analysis of expired gases. Participants will also have an ECG attached so their heart rate can be monitored throughout the test. This test will take approximately 5-10 minutes.

Other outcome measures are:
* a questionnaire describing their physical activity over the last 7 days (Active Australia Survey),
* blood pressure measured via a sphygmomanometer,
* waist and hip measurements using a tape measure,
* height and weight measures, using a stadiometer and weight scales.
Intervention code [1] 296859 0
Not applicable
Comparator / control treatment
Peak treadmill test.
Control group
Active

Outcomes
Primary outcome [1] 300746 0
2-minute step test number of steps.
Timepoint [1] 300746 0
Day of testing.
Primary outcome [2] 300747 0
Peak oxygen consumption from the incremental peak treadmill fitness test.
Timepoint [2] 300747 0
Day of testing.
Secondary outcome [1] 330773 0
Physical activity using the Active Australia Survey.
Timepoint [1] 330773 0
Day of testing.
Secondary outcome [2] 330774 0
Blood pressure using a mercury sphygmomanometer,
Timepoint [2] 330774 0
Day of testing.
Secondary outcome [3] 330775 0
Waist and hip measurements using a tape measure.
Timepoint [3] 330775 0
Day of testing.
Secondary outcome [4] 330776 0
Height and weight measures, using a stadiometer and weight scales.
Timepoint [4] 330776 0
Day of testing.
Secondary outcome [5] 330777 0
Heart rate at rest and at the end (first 15 seconds following completion of the 2-minute step test) of the 2-minute step test taken manually and using a heart rate monitor.
Timepoint [5] 330777 0
Day of testing.

Eligibility
Key inclusion criteria
Inclusion criteria:
1. Between 40 and 60 years old.
2. They will have no serious medical conditions that could limit participation in either fitness test, such as unstable angina, uncontrolled hypertension, diagnosed or hospitalized with chest pain, heart attack or heart surgery in the past 6 months and no severe functional impairments due to multiple medical or psychiatric diseases.
3. Participants will have adequate English skills and have appropriate cognitive skills to provide informed consent and follow instructions for the fitness tests.
Minimum age
40 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria
Medical clearance screening will be undertaken using the Sports Medicine Australia (SMA) Pre-Exercise Screening System. If the participant answers ‘yes’ to any of the SMA screening questions, they will be asked to attend their local medical officer to receive medical clearance before they can be included in the study.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The number of steps completed by the right leg in the 2MST will be compared to the directly measured VO2peak (peak treadmill test) to determine its validity.
The strength of the relationship between the tests will be assessed using the Pearson correlation coefficient and multiple linear regression analyses will be used to create a predictive equation for VO2peak.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/09/2018
Actual
1/04/2019
Date of last participant enrolment
Anticipated
6/05/2019
Actual
12/12/2019
Date of last data collection
Anticipated
31/05/2019
Actual
19/12/2019
Sample size
Target
36
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 295336 0
University
Name [1] 295336 0
University of Canberra
Country [1] 295336 0
Australia
Primary sponsor type
Individual
Name
Dr Nicole Freene
Address
Physiotherapy
Faculty of Health
University of Canberra
Bruce ACT 2601
Country
Australia
Secondary sponsor category [1] 294162 0
Individual
Name [1] 294162 0
Kellie Toohey
Address [1] 294162 0
Exercise and Sports Science
Faculty of Health
University of Canberra
Bruce ACT 2601
Country [1] 294162 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296673 0
University of Canberra's Human Research Ethics Committee
Ethics committee address [1] 296673 0
Ethics committee country [1] 296673 0
Australia
Date submitted for ethics approval [1] 296673 0
30/08/2016
Approval date [1] 296673 0
28/10/2016
Ethics approval number [1] 296673 0
HREC 16-212

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

Contacts
Principal investigator
Name 71714 0
Dr Nicole Freene
Address 71714 0
Physiotherapy
Faculty of Health
University of Canberra
Bruce ACT 2601
Country 71714 0
Australia
Phone 71714 0
+61 2 6201 5550
Fax 71714 0
Email 71714 0
[email protected]
Contact person for public queries
Name 71715 0
Nicole Freene
Address 71715 0
Physiotherapy
Faculty of Health
University of Canberra
Bruce ACT 2601
Country 71715 0
Australia
Phone 71715 0
+61 2 6201 5550
Fax 71715 0
Email 71715 0
[email protected]
Contact person for scientific queries
Name 71716 0
Nicole Freene
Address 71716 0
Physiotherapy
Faculty of Health
University of Canberra
Bruce ACT 2601
Country 71716 0
Australia
Phone 71716 0
+61 2 6201 5550
Fax 71716 0
Email 71716 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data for all outcome measures.
When will data be available (start and end dates)?
2019-2024
Available to whom?
Researchers wishing to use the data for further analyses, if the request is reasonabale.
Available for what types of analyses?
2MST validation analyses.
How or where can data be obtained?
From the corresponding author via email [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCriterion Validity of the Older-adults 2-minute Step Test in Community-dwelling Middle-aged Adults.2021https://dx.doi.org/10.1080/1091367X.2021.1904934
N.B. These documents automatically identified may not have been verified by the study sponsor.