Table 4 Tests and relevant parameters measured necessary to achieve trial objectives
Test | Parameters studied (primary outcome, all sites) |
Exercise test on cycle ergometer (cardiopulmonary exercise test (CPET)) using a ramp protocol | Cardiorespiratory fitness (VO2PEAK) |
Test | Parameters studied (secondary outcomes (selected sites and/or ancillary studies)) |
Exercise test on cycle ergometer (cardiopulmonary exercise test (CPET)) using a ramp protocol | Pre-exercise spirometry, HR and rhythm, oxygen saturation, blood pressure, and ventilatory response to exercise |
Strength testing | 1-repetition maximum (1RM) for leg press, seated row and chest press |
Near-infrared spectroscopy (NIRS) | Skeletal muscle oxidative capacity |
Flow-mediated dilation | Brachial artery diameter and assessment of endothelial function |
Dual-energy X-ray absorptiometry (DEXA) | Lean appendicular muscle mass, fat mass, bone mineral content, and bone density |
Accelerometer (ActiGraph GT9X Link device) for participants | 7-day measurement (minimum 3 days each 8 h) for each group of parameters pertinent to physical activity, activity intensity, sedentary time, and sleep and sleep quality |
Automated Self-Administered Recall System (ASA24), Gastrointestinal Symptom Rating Scale (GSRS), and Subjective Global Assessment (SGA) | Dietary intake history compiled by recalling type and quantity of nutrition ingested Gut function assessed by self-evaluation of the following five symptom clusters: reflux, abdominal pain, indigestion, diarrhoea, and constipation State of nourishment (well-, mal-) clinically assessed using functional capacity, solids/fluids intake, metabolic requirement, and physical examination |
Self-administered digital Cogstate assessment—tests include detection, identification, one card learning, one back test, Groton maze chase, Groton maze learning, international shopping list, and social emotion cognition | Cognitive function assessed for the following domains: p sychomotor function, attention, visual learning/memory, working memory, processing speed, executive function, verbal learning/memory, and social emotional cognition |
Duke Activity Status Index, Self-assessed NYHA functional classification | Self-assessed functional capacity determined by ability to participate in daily activities of living such as self-care, housework, gardening, and recreational physical activities, and presence/severity of symptoms (e.g. fatigue, palpitations, dyspnoea) accompanying each activity |
Fatigue Severity Scale | Self-assessed levels of fatigue for the past 7 days encompassing causes of fatigue, problems caused by fatigue, and effect of fatigue on daily activity types and levels |
EQ-5D [43] | Self-assessed health-related quality of life encompassing levels of mobility, self-care, physical activities, pain/discomfort, and anxiety/depression |
International physical activity questionnaire and exercise self-efficacy questionnaire [44] | Self-reported habitual physical activity and self-efficacy levels using volume of time spent in various physical activities |
Laboratory assessments via blood collection to capture relevant biomarkers (not all sites) | 1. Full blood count (FBC) 2. N-terminal pro hormone B-type natriuretic peptide (NT-proBNP) 3. Highly sensitive C-reactive protein (hsCRP) 4. Comprehensive metabolic panel including alanine aminotransferase (ALT), aspartate transaminase (AST), bilirubin, urea, creatinine, calcium, magnesium, phosphates, electrolytes, and fasting blood glucose levels (FBG) 5. Fasting insulin 6. Prealbumin 7. Fasting lipid profile plus apolipoprotein A1 and B100 8. Multi-omic analyses (plasma) |