Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Safety composite outcome |
This will be reported as the number of people who reach the composite safety outcome (the occurrence of at least one) of the following measured variables 1)cardiovascular death; 2)cardiac arrest; 3) appropriate or inappropriate ICD therapy; 4)exercise induced syncope; 5)sustained ventricular tachycardia; 6) non-sustained ventricular tachycardia; or 7)sustained atrial arrhythmias >30seconds post testing and at 6 months. |
6 months |
|
| Primary |
Feasibility (qualitative outcome) |
Feasibility will be reported qualitatively using an open ended questionnaire through analysis of the following a) response to invitation to participate and reasons for refusal; b) adherence to the cardiac rehabilitation programme; c) practical issues related to the programme including staffing and resource assessment; d) acceptability of the intervention and educational materials provided to patients and families |
12 weeks |
|
| Secondary |
Impact on exercise capacity; time to anaerobic threshold (tAT) (seconds) |
This variable will be assessed individually and compared to baseline values post testing and at 6 months. |
6 months |
|
| Secondary |
Impact on exercise capacity; total exercise time (tMax) (seconds) |
This variable will be assessed individually and compared to baseline values post testing and at 6 months. |
6 months |
|
| Secondary |
Impact on exercise capacity; VO2(ml/kg/min) at AT (VO2/kgAT) (ml/kg/min) |
The anaerobic threshold (AT) was calculated initially using the V slope method (visual estimation from the VCO2 and VO2 graphs at the point where the slope of the VCO2 curve exceeded the slope of the VO2 curve). This was checked manually using the raw data and 10 second averaging. All data was additionally averaged over 10 seconds at this point and the averaged VO2 ml/kg/min value used as the VO2 at the AT. This variable will be assessed individually and compared to baseline values post testing and at 6 months. |
6 months |
|
| Secondary |
Impact on exercise capacity; peak VO2(ml/kg/min) (VO2/kgMax) (ml/kg/min) |
CPET analysis was performed using COSMED Quark CPET metabolic cart (Rome, Italy). This automatically calculated peak VO2 ml/min and converted it to ml/kg/min using the patient's weight which had been inputted into the program prior to commencing the CPET. This variable will be assessed individually and compared to baseline values post testing and at 6 months. |
6 months |
|
| Secondary |
Impact on exercise capacity; VE/VCO2 slope (ratio) |
This variable will be assessed individually and compared to baseline values post testing and at 6 months. |
6 months |
|
| Secondary |
Impact on exercise capacity; physical activity levels (hours/week) |
This variable will be assessed individually and compared to baseline values post testing and at 6 months. |
6 months |
|
| Secondary |
Impact on cardiovascular risk factors; blood pressure (BP) (mmHg) |
This variable will be assessed individually and compared to baseline values post testing and at 6 months. |
6 months |
|
| Secondary |
Impact on cardiovascular risk factors; body mass index (BMI) (kg/m2) |
This variable will be assessed individually and compared to baseline post testing and at 6 months. |
6 months |
|
| Secondary |
Impact on cardiovascular risk factors; lipid profile (mmol/l) |
This variable will be assessed individually and compared to baseline values post testing. |
12 weeks |
|
| Secondary |
Impact on cardiovascular risk factors; HbA1c (mmol/mol) |
This variable will be assessed individually and compared to baseline values post testing. |
12 weeks |
|
| Secondary |
Impact on QoL and psychological parameters; Short form 36 (SF36) scores |
This variable will be assessed individually and compared to baseline values post testing and at 6 months. The SF-36 is comprised of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is converted into a 0-100 scale, with a lower score denoting greater disability. |
6 months |
|
| Secondary |
Impact on QoL and psychological parameters; Hospital anxiety and depression scale (HADS) scores |
This variable will be assessed individually and compared to baseline values post testing and at 6 months. The HADS questionnaire consists of seven items each for depression and anxiety. Each item is scored from zero to three, with three the highest anxiety or depression level. Either an anxiety or depression score of >8 points (total 21) denotes considerable symptoms of anxiety or depression. |
6 months |
|
| Secondary |
Impact on QoL and psychological parameters; WHO disability assessment scale II (WHODAS II) scores |
This variable will be assessed individually and compared to baseline values post testing and at 6 months. The WHODAS II score can be calculated using simple scoring where the following scores are assigned to each item - none (1), mild (2) moderate (3), severe (4) and extreme (5). The scores are then summed, with a higher score denoting greater disability. |
6 months |
|
| Secondary |
Impact on disease phenotype-cardiac biomarkers; troponin (ng/l) |
This variable will be assessed individually and compared to baseline values post testing. |
12 weeks |
|
| Secondary |
Impact on disease phenotype-cardiac biomarkers; BNP (ng/l) |
This variable will be assessed individually and compared to baseline values post testing. |
12 weeks |
|
| Secondary |
Impact on disease phenotype-echocardiographic outcomes; LA volume (ml) |
This variable will be assessed individually and compared to baseline values post testing. |
12 weeks |
|
| Secondary |
Impact on disease phenotype-echocardiographic outcomes; LVEDD (mm) |
This variable will be assessed individually and compared to baseline values post testing. |
12 weeks |
|
| Secondary |
Impact on disease phenotype-echocardiographic outcomes; LVWT (mm) |
This variable will be assessed individually and compared to baseline values post testing. |
12 weeks |
|
| Secondary |
Impact on disease phenotype-echocardiographic outcomes; diastolic parameters (E/E', E/A)) |
This variable will be assessed individually and compared to baseline values post testing. |
12 weeks |
|
| Secondary |
Impact on disease phenotype-ventricular ectopic burden; |
The absolute number of ventricular ectopics will be assessed and compared to baseline values post testing post testing and at 6 months. |
6 months |
|
