Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000605695
Ethics application status
Approved
Date submitted
16/04/2023
Date registered
2/06/2023
Date last updated
2/06/2023
Date data sharing statement initially provided
2/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Validation of accelerometer cut-points for physical activity intensities in people with coronary heart disease.
Scientific title
Validation of accelerometer cut-points for physical activity intensities in people with coronary heart disease.
Secondary ID [1] 309467 0
Nil
Universal Trial Number (UTN)
U1111-1291-3774
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
coronary heart disease 329726 0
Aerobic capacity 329727 0
Physical inactivity 329728 0
Condition category
Condition code
Cardiovascular 326627 326627 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Design
This validation study for accelerometer cut-point development in people with coronary heart disease will be conducted in Australia over 18-months. Eligible participants will be required to attend the University of Canberra in Bruce for up to 2 hours and complete a peak incremental treadmill test and some activities of daily living, allowing an adequate rest in between tests to minimize fatigue. The treadmill test will be completed first, followed by the activities of daily living. During all tests participants will be required to wear a face mask for gas analysis (measurement of oxygen consumption). No further involvement is required. Gas analysis data from the treadmill and activity testing will be compared with the accelerometer data to develop equations (cut points) to classify physical activity intensity.

Accelerometry:
An ActiGraph triaxial commercial accelerometer will be used to objectively assess physical activity during the treadmill test and the activities-of-daily-living. Participants will be asked to wear the accelerometer around their waist, over their right hip throughout the testing, as well as around their non-dominant wrist on the dorsal aspect. The data collected by the accelerometer, counts, will be compared to oxygen consumption (VO2).

Peak treadmill test:
Direct measurement of aerobic fitness (oxygen consumption, VO2) will be determined via an incremental exercise test on a treadmill. Participants will begin walking at an easy level and the treadmill speed and/or gradient will be increased incrementally to volitional or symptom-limited exhaustion. The participants will be fitted with a facemask to enable the analysis of expired gases, measuring VO2. Prior to the treadmill test participants will complete a seated resting-metabolic-rate assessment. Expired gases will be collected continuously and individual resting-metabolic-rate will be determined. During the treadmill test, participants will also be fitted with a 12-lead ECG and blood pressure cuff, and their ECG and blood pressure will be monitored by a medical practitioner with advanced cardio-pulmonary resuscitation (CPR) qualifications throughout the test.

Activities of daily living (ADL):
Following the treadmill test participants will complete a series of ADL simulations including; watching television (sedentary), seated stretching, standing stretching, floor sweeping and stepping in place (higher intensity). Each ADL will be completed for 5-minutes according to standardized instructions, with 10-minutes seated rest between tasks or until heart rate returns to resting level. Throughout activity simulations participants will be fitted with a facemask to enable the analysis of expired gases.

Other outcome measures are:
- video recording of lower limbs to accurately record steps completed throughout the treadmill test
- height and weight measures
- completion of a demographic and clinical questionnaire.

164 participants with coronary heart disease will be recruited to this trial, including a small cohort of participants that also have class I-II heart failure (n=20). For the data analysis, the study sample (n=164) will be randomly split into a learning set and an independent validation set (2:1), allowing for a cross validation statistical procedure using a sub-sample of participants. No participants will be required to undergo further testing.
Intervention code [1] 325888 0
Early Detection / Screening
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334490 0
Accelerometer counts.
An ActiGraph triaxial commercial accelerometer will be used to objectively assess physical activity during the treadmill test and the activities-of-daily-living. Participants will be asked to wear the accelerometer around their waist, over their right hip throughout the testing, as well as around their non-dominant wrist on the dorsal aspect. To record timing of activities, a clock will be used that is synchronised with the accelerometer clock. All accelerometers will be initialized at 30 Hz and data will be downloaded in 1-second epochs and counts-per-minute (cpm).
Timepoint [1] 334490 0
Assessed continuously while completing the treadmill test and activities of daily living.
Primary outcome [2] 334491 0
Oxygen consumption.

Oxygen consumption will be assessed continuously using a facemask to enable the analysis of expired gases, measuring VO2, while completing the treadmill test and activities of daily living. This will be a composite measure.
Timepoint [2] 334491 0
Assessed continuously while completing the treadmill test and activities of daily living.
Secondary outcome [1] 421444 0
Step rate from the incremental peak treadmill test.

To objectively assess steps one of the research team will manually count steps using a hand tally counter throughout the treadmill test. A video will also record the participants lower limbs throughout the treadmill test to verify the manually counted steps.
Timepoint [1] 421444 0
Assessed continuously while completing the treadmill test.

Eligibility
Key inclusion criteria
Participants will be eligible to take part in the study if they are aged 18+, have stable coronary heart disease (CHD) and are receiving optimal medical treatment +/- revascularisation, that is, coronary artery bypass graft surgery (CABG), percutaneous coronary intervention (PCI), or have had a myocardial infarction (MI).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they have primary atrial fibrillation, New York Heart Association class III-IV symptoms of heart failure (or documented signs and symptoms of chronic heart failure, with ejection fraction < 45%), uncontrolled arrhythmias, severe chronic obstructive pulmonary disease, uncontrolled hypertension, symptomatic peripheral artery disease, unstable angina, uncontrolled diabetes, are unable to perform a maximal walking test on a treadmill, or are unable to wear an accelerometer due to disability, for example, if they are confined to a wheelchair. Medical clearance to participate in the study will be required from the participants cardiologist or cardiothoracic surgeon and/or the medical practitioner (Sports Physician) conducting the pre-exercise screening. Eligible participants must have adequate language (English speaking only) and cognitive skills.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The last minute of each stage will be used to reflect counts-per-minute, step rate and gas analysis (VO2) for each stage interval on the treadmill and each ADL. Measured metabolic equivalent of tasks (METs) will be calculated for each stage by dividing steady-state VO2 by actual resting-metabolic-rate. Percentage peak VO2 will also be calculated for each stage. Counts-per-minute cut-points will be calculated by rearranging regression equations to solve for upper and lower margins of light, moderate and vigorous absolute (METs) and relative (%VO2peak) intensity, and sedentary behaviour. Therefore, two equations will be developed, one for absolute and one for relative intensity, adjusted for covariates. Also, counts-per-minute cut-points will be developed for the accelerometer y-axis (vertical axis) and vector magnitude counts (vector magnitude is a composite measure of all three accelerometer axes (vx2+y2+z2)), and for the different accelerometer wear sites (i.e., hip vs wrist).

Bland-Altman plots will be used to determine differences between the actual and developed cut-points (absolute and relative) for moderate-to-vigorous physical activity counts-per-minute and the average of the two measures, with mean differences and 95% limits of agreement, in a sub-sample of participants (validation set). Linear regression will be used to check whether the mean difference and limits of agreement varies across average values of actual and developed moderate-to-vigorous physical activity counts-per-minute after visual examination of the plots.

Mean values for the two newly developed cut-points (absolute and relative intensity) time spent in daily minutes of moderate-to-vigorous physical activity will be compared to commonly used accelerometer cut-points (e.g. Sasaki VM cut-points) using paired Wilcoxon signed rank sum tests in the international cardiac rehabilitation accelerometer data (Australia and Sweden, n=520) that has been collected by the research team in previous studies. The proportion of those meeting the moderate-to-vigorous physical activity guidelines between the three cut-points will be compared using a chi-square analysis. Significance level will be set at p<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/06/2023
Actual
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
31/10/2024
Actual
Sample size
Target
164
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 313662 0
Commercial sector/Industry
Name [1] 313662 0
ActiGraph
Country [1] 313662 0
United States of America
Funding source category [2] 313663 0
University
Name [2] 313663 0
University of Canberra
Country [2] 313663 0
Australia
Primary sponsor type
Individual
Name
A/Prof Nicole Freene
Address
Faculty of Health
11 Kirinari St
University of Canberra
Bruce ACT 2601
Country
Australia
Secondary sponsor category [1] 315462 0
Individual
Name [1] 315462 0
Prof Rachel Davey
Address [1] 315462 0
Health Research Institute
11 Kirinari St
University of Canberra
Bruce ACT 2601
Country [1] 315462 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312829 0
University of Canberra Human Research Ethics Committee
Ethics committee address [1] 312829 0
Ethics committee country [1] 312829 0
Australia
Date submitted for ethics approval [1] 312829 0
28/02/2019
Approval date [1] 312829 0
09/04/2019
Ethics approval number [1] 312829 0
HREC -1872

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

Contacts
Principal investigator
Name 126066 0
A/Prof Nicole Freene
Address 126066 0
Faculty of Health
11 Kirinari St
University of Canberra
Bruce ACT 2601
Country 126066 0
Australia
Phone 126066 0
+61262015550
Fax 126066 0
Email 126066 0
[email protected]
Contact person for public queries
Name 126067 0
Nicole Freene
Address 126067 0
Faculty of Health
11 Kirinari St
University of Canberra
Bruce ACT 2601
Country 126067 0
Australia
Phone 126067 0
+61262015550
Fax 126067 0
Email 126067 0
[email protected]
Contact person for scientific queries
Name 126068 0
Nicole Freene
Address 126068 0
Faculty of Health
11 Kirinari St
University of Canberra
Bruce ACT 2601
Country 126068 0
Australia
Phone 126068 0
+61262015550
Fax 126068 0
Email 126068 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)?
2025-2030
Available to whom?
Researchers wishing to use the data for further analyses, if the request is reasonabale.
Available for what types of analyses?
Accelerometer 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
No additional documents have been identified.