ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Condition category

Condition code

Public Health

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]

Not applicable

Comparator / control treatment

Peak treadmill test.

Control group

Active

Outcomes

Primary outcome [1]

2-minute step test number of steps.

Timepoint [1]

Day of testing.

Primary outcome [2]

Peak oxygen consumption from the incremental peak treadmill fitness test.

Timepoint [2]

Day of testing.

Secondary outcome [1]

Physical activity using the Active Australia Survey.

Timepoint [1]

Day of testing.

Secondary outcome [2]

Blood pressure using a mercury sphygmomanometer,

Timepoint [2]

Day of testing.

Secondary outcome [3]

Waist and hip measurements using a tape measure.

Timepoint [3]

Day of testing.

Secondary outcome [4]

Height and weight measures, using a stadiometer and weight scales.

Timepoint [4]

Day of testing.

Secondary outcome [5]

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]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Canberra

Address [1]

Faculty of Health
University of Canberra
Bruce ACT 2601

Country [1]

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]

Individual

Name [1]

Kellie Toohey

Address [1]

Exercise and Sports Science
Faculty of Health
University of Canberra
Bruce ACT 2601

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Canberra's Human Research Ethics Committee

Ethics committee address [1]

Research Services Office
Building 1 Level D Room 88
University of Canberra
Bruce ACT 2601

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/08/2016

Approval date [1]

28/10/2016

Ethics approval number [1]

HREC 16-212

Summary

Brief summary

Evidence suggests that poor cardiorespiratory (CR) fitness is associated with increased risk of morbidity and mortality, and is therefore used as a measure of health. Submaximal exercise testing is commonly used in practice to assess CR fitness due to time constraints, lack of equipment and safety. Submaximal step tests have been shown to be valid method of assessing CR fitness (Bennett et al 2016), although the majority of these tests require a step and are externally paced. The 2-minute step test (2MST) requires minimal equipment (no step) and is self-paced. It has been shown to be reliable and valid in an older population (60+ years old) (Rikli and Jones 1999). If the 2MST is found to be valid in a wider age range, it may be a simpler method of assessing CR fitness that can be used in a variety of settings, potentially preventing a decline in health and physical fitness in the population. Here we will compare the number of steps completed in the 2MST in middle-aged adults to a direct measure of peak oxygen consumption (cardiorespiratory fitness) using an incremental cycle test.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Nicole Freene

Address

Physiotherapy
Faculty of Health
University of Canberra
Bruce ACT 2601

Country

Australia

Phone

+61 2 6201 5550

Fax

nicole.freene@canberra.edu.au

Contact person for public queries

Name

Nicole Freene

Address

Physiotherapy
Faculty of Health
University of Canberra
Bruce ACT 2601

Country

Australia

Phone

+61 2 6201 5550

Fax

nicole.freene@canberra.edu.au

Contact person for scientific queries

Name

Nicole Freene

Address

Physiotherapy
Faculty of Health
University of Canberra
Bruce ACT 2601

Country

Australia

Phone

+61 2 6201 5550

Fax

nicole.freene@canberra.edu.au

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 nicole.freene@canberra.edu.au

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

Source	Title	Year of Publication	DOI
Embase	Criterion Validity of the Older-adults 2-minute Step Test in Community-dwelling Middle-aged Adults.	2021	https://dx.doi.org/10.1080/1091367X.2021.1904934

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically