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Validation of accelerometer cut-points for physical activity intensities in people with coronary heart disease.

Validation of accelerometer cut-points for physical activity intensities in people with coronary heart disease.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12623000605695
Enrollment
90
Registered
2023-06-02
Start date
2023-06-10
Completion date
2025-02-06
Last updated
2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Physical inactivity is an independent risk factor for all causes of death in people with heart disease. Thus, accurate measurement of physical activity is essential to ensure optimal physical activity levels are achieved. Wearable activity monitors (accelerometers) offer a method for objective quantification of physical activity frequency, duration and intensity, however, a limitation of the few studies that measure physical activity using accelerometers in this population, is the use of inappropriate accelerometer intensity cut-points derived from healthy populations. Given people with heart disease may have reduced exercise capacity resulting in greater effort for the same activities, this may lead to inaccurate intensity classification (i.e., under-reporting) of physical activity levels. Here we will recruit 164 participants with heart disease to complete a treadmill test and a series of activities-of-daily-living with simultaneous measurement of oxygen uptake and activity counts taken from accelerometers, developing heart disease specific cut-point equations for different physical activity intensities. This project will generate new knowledge, allowing the disease-specific relationship between physical activity and health outcomes to be accurately established. This will guide future physical activity recommendations and interventions, helping more people live longer and healthier after a cardiac event.

Interventions

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

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.

Sponsors

A/Prof Nicole Freene
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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).

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Aug 31, 2026