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Table 1 Screening, primary and secondary outcome measures

From: Physical Activity after Cardiac EventS (PACES) – a group education programme with subsequent text-message support designed to increase physical activity in individuals with diagnosed coronary heart disease: study protocol for a randomised controlled trial

 

Measurement type

Measurement (units)

Baseline

6 months

12 months

Screening

Demographic data

Date of birth, age, gender, ethnicity,

x

  

smoking status, alcohol status employment status

x

 

x

Health history

Type of cardiac event defining as eligible, date of CHD diagnosis,

X

  

medical history and medications, whether family history of CHD

x

 

x

Primary outcome measure

Physical activity

Accelerometer (average daily physical activity - milli-gravitational units (mg))

x

x

x

Secondary outcome measures

Aerobic fitness

Incremental Shuttle Walk Test (metres)

x

 

x

Anthropometric

Height (cm) and body mass (kg)

x

 

x

Body Mass Index (kg/m2)

Waist circumference (cm)

Hip circumference (cm)

Waist to hip ratio

Cardiovascular

Blood pressure (mmHg) and resting heart rate (bpm)

x

 

x

Blood samples (all non-fasting)

Lipid profile (cholesterol, HDL, LDL, triglycerides)

x

 

x

HbA1c (mmol/mol, %)

Questionnaires

Jenkins Self-efficacy for Exercise Expectations Scale [45]

x

x

x

Hospital Anxiety and Depression Scale (HADS) [58]

x

x

x

MacNew Heart Disease [43, 44]

x

x

x

Recent Physical Activity Questionnaire (RPAQ) [40]

x

x

x

EuroQoL (EQ-5D-5L) health-related quality of life instrument [43, 44]

x

x

x

Morningness-Eveningness Questionnaire [49, 50]

x

  

Exploratory endpoint

Stored serum and plasma samples

Biomarkers of inflammation, proteomics, metabolomics and novel markers of cardiovascular health

x

 

x

  1. CHD coronary heart disease, HbA1c glycosylated hemoglobin, HDL high-density lipoprotein, LDL low-density lipoprotein